Jerusalem, Israel, June 4, 2013 / B3C newswire / - RegeneCure Ltd., a  developer of novel regenerative membrane implant technology for the treatment of human and animal bone fractures,  announced today that the company has started to distribute its BoneCure® Membrane product to the veterinary market around the world.

The distribution follows the successful results of a recent clinical study in several EC countries and Israel.  BoneCure Membrane was used by European Veterinary Surgeons in pets for the following indications: non-union, large bone gaps, arthrodesis and severe fractures. The study showed that the healing time was about 40 percent quicker than normally observed using current Standard of Care therapies.

"Based on the outstanding safety and efficacy results of our clinical and pre-clinical studies, we expect BoneCure to enable veterinary surgeons to treat a larger number of severe fracture types and to significantly reduce the healing time and complication rate," said Moshe Tzabari, CEO of RegeneCure.

Distribution with dealers is now underway throughout Europe, Asia, Australia and the United States.

The use of the BoneCure Membrane for carpal arthrodesis is a major breakthrough in the surgery of companion animals that offers many advantages over the traditional “Gold Standard” procedure of harvesting an autogenous bone graft. This procedure, described at the BoneCure website, prevents patient morbidity and pain, reduces the risks of infection and fracture at the donor site, saves operating time and eliminates the need for a second incision.

Carpal Arthrodesis by BoneCure® Membrane
First reported case with no use of bone graft

Caption: Carpal Arthrodesis treated with the BoneCure Membrane:  First reported case without the use of a bone graft. For details see here.
(For high resolution picture please click the image)

Course on Small Animal Arthrodesis Sept. 27-28 in Germany

RegeneCure’s major distributor in Europe, Eickemeyer Veterinary Equipment, is organizing a practical two day course called “Small Animal Arthrodesis” on September 27 -28, 2013 at the Eickemeyer Centre for Veterinary Continuing Education, Tuttlingen, Germany. The course will be conducted by Ignacio Calvo, Ldo Vet, CertSAS, MRCVS, Head of Small Animal Orthopaedic Surgery, University of Glasgow, and Michael Farrell, BVetMed, CertVA, CertSAS, MRCVS, Senior Surgeon, Fitzpatrick Referrals. The course participants will develop theoretical and practical clinical decision-making skills about how and when to perform arthrodesis.

About BoneCure
RegeneCure's regenerative BoneCure membrane implant is cationic and has a microporous surface. Due to its osteoconductive stimulation, the membrane optimizes proliferation and differentiation of the MSCs into bone tissue in the area of need. This helps promote rapid bone healing by Guided Bone Regeneration.
The BoneCure membrane is thin and flexible, drillable and easily sutured in the treated area. It is easy to use in orthopedic surgery and requires no special surgical knowledge or preparation prior to use.

About RegeneCure
RegeneCure Ltd. was founded in July 2010 to develop, produce and market synthetic implants for bone reconstruction and fracture fusion for the orthopedic, dental and aesthetic fields. AMCA Membrane Implant technology is protected by worldwide patents. The company submitted a 510(k) application to the FDA in April 2012 for an initial trauma indication. The privately owned company has manufacturing facilities capable of meeting the high production standards required by European and United States authorities. In 2012, the company received ISO 13485:2003 certification.

Contacts

Dr. Harry Langbeheim
VP Business Development
RegeneCure Ltd.
harry@regenecure.co.il

Aiz Baig BVSc, MBA, MRCVS
Eickemeyer Veterinary Equipment Ltd.
Aiz@eickemeyer.co.uk

Konstanz, Germany, June 5, 2013 / B3C newswire / – GATC Biotech, the European leader for DNA sequencing, has designed InView™ 1-Week Exome Diagnostic especially for diagnostic purposes. This service enables early detection of multiple genetic variants presumably responsible for diverse genetic disease markers within just 7 days, the world’s fastest turn-around time available. With its DIN EN ISO/IEC 17025 certified Next Gen Sequencing laboratories, GATC Biotech offers this application e.g. for detection of cancerous cells or early detection of other genetic diseases.

The application supports clinicians to initiate urgent treatments and opens the way to a more personalised patient care in the field of cancer, metabolic dysfunctions and immunological diseases. With a combination of standardised workflows and highest quality standards, InView™ 1-Week Exome Diagnostic is an overall solution for fast and reliable variant detection. Focusing on the functional relevant coding regions, only approx. 1% of the human genome (the exome) needs to be sequenced. This provides an efficient advantage for diagnostics and clinical research.

“Next Generation Sequencing technologies have set a new level in the field of clinical research and diagnostics. 1-Week Exome Diagnostic is an all-in-one service delivering rapid results for early detection of diseases for our customers in diagnostics, clinical and pharmaceutical research”, tells Dr. Marcus Benz, COO at GATC Biotech. “Being the leading service provider for NGS solutions, scientists can profit from our thorough experience in exome analysis while receiving accurate results in only 7 days.”

Essential requirements for the competence of analysis and calibration laboratories such as DIN EN ISO/IEC 17025 and DIN EN ISO 9001 by the national accreditation body for the Federal Republic of Germany (DAkkS) have been fulfilled by GATC Biotech’s NGS laboratories. The application is based on Agilent SureSelectXT Human All Exon V5 enrichment and Illumina MiSeq.

About GATC Biotech
GATC Biotech is Europe’s leading service provider of DNA sequencing with more than 10,000 academic and industrial customers worldwide. For over two decades, we have offered sequencing and bioinformatics solutions from single samples up to large scale projects. GATC Biotech has sequenced more than 5 million samples, ten thousands of bacterial, plant and other whole genomes as well as hundreds of whole human genomes.

Having Agilent and Illumina Certified Service Provider status, GATC Biotech offers true multiplatform sequencing using all leading sequencing technologies in its own labs. In order to evaluate these immense data quantities professionally, GATC Biotech keeps its own IT farm.

Headquartered in Constance Germany, the company houses its ISO 17025 certified Genome and Diagnostic Centre with a focus on Next and Third Generation sequencing. The European Custom Sequencing Centre located in Cologne focuses on Sanger Sequencing and serves as the logistical hub within Europe. All laboratories have highly integrated and fully automatic processing pipelines and enable full compliance with latest state-of-the-art quality standards. Since 2010, GATC Biotech has been a key supplier for the International Cancer Genome Project.

GATC Biotech´s subsidiary LifeCodexx emphasizes the development of clinically validated molecular diagnostic tests and offers a risk-free alternative to common invasive examination methods such as amniocentesis.

Contact

Lisa-Annina Quintes
GATC Biotech AG
Jakob-Stadler-Platz 7
78467 Konstanz
Germany
Phone: +49 (0) 7531-81604117
Fax: +49 (0) 7531-816081
 l.quintes@gatc-biotech.com

Penzberg, Germany, June 6 2013 / B3C newswire / - Roche today announced the global launch of new software updates, including advanced high- resolution melting analysis and qualitative detection modules for the LightCycler 96 and new support features for the LightCycler Nano system.

The new LightCycler 96 module for high- resolution melting analysis will be particularly valuable in human genetic disease research applications. It enables easy and fast detection of known and unknown gene mutations, including Single Nucleotide Polymorphisms, deletions and methylated regions. The novel dedicated qualitative detection module for LightCycler 96 enables direct detection and validation of a target gene´s presence or absence. This module also employs a novel control concept and is designed mainly for customers doing research in the field of infectious diseases.    

The new features of the LightCycler Nano include advanced gene expression analysis mediated by the import of external standard curves. It also offers an enhanced analysis method for high- resolution melting experiments.

 “The launch of these new software tools underlines our ongoing commitment to broadening the innovative features offered by our PCR systems,” said Gerd Haberhausen, Head of qPCR and Sample Preparation Systems. “We can build on almost 15 years of expertise in developing high-performance PCR systems that enable research breakthroughs for our customers around the world.”    

Roche launched the LightCycler 96 System in October 2012 with a variety of analysis methods including endpoint genotyping and absolute and relative quantification. Data generated by the system can be analyzed directly or remotely for translation into publication-ready results in line with MIQE* guidelines. With the new software it will also be possible to create PDF or HTML reports.                 

The new software tools for the LightCycler 96 and LightCycler Nano systems will be supplied on a USB stick and will also be available to all customers for immediate download at www.lightcycler.com.      

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

LIGHTCYCLER is a trademark of Roche
All other product names and trademarks are the property of their respective owners.

For life science research only. Not for use in diagnostic procedures.

*MIQE: Minimum information required for publication of quantification experiments

For further information please contact:

Roche Diagnostics
Dr. Claudia Schmitt
Phone: +49 8856 60 10210
Email: claudia.schmitt@roche.com

Hørsholm, Denmark, and London, UK, 10th June, 2013 / B3C newswire / – Biotech company ExpreS²ion Biotechnologies today announced that they have signed a research license agreement to provide the Protein Purification Facility at Cancer Research UK’s London Research Institute  with access to its Drosophila Schneider-2 cell-based technology platform - ExpreS² - for protein production. The stable, non-lytic protein expression platform, which is fully cGMP compatible, will complement the existing capabilities in protein expression at the Protein Purification Facility. The platform will be used to address expression of complex and “challenging” proteins, including Fab fragments and other proteins.

This license is a relevant addition to ExpreS²ion Biotechnologies’ vision of making its production platform available to academic centers of excellence globally, in complement to the Company’s strategy of making S2 one of the standard protein production platforms in the immunotherapy and therapeutic protein segments.

Dr. Charlotte Dyring, CEO of ExpreS²ion Biotechnologies, said: “We are excited to sign this license agreement with the Protein Production Facility of Cancer Research UK, one of the world research centers of excellence for cancer biology. We have in the past used the ExpreS² protein expression system to enable the advance of cancer projects, and this Research License confirms the relevance of the system in complementing existing protein needs in cancer research.”

Dr. Svend Kjaer, Head of the Protein Purification Facility at the London Research Institute commented: “We are very pleased with the capabilities demonstrated by the ExpreS² platform, which we have employed for a number of our taxing projects. The technology complements our baculovirus-based protein expression activities perfectly and we look forward to expanding the application range of the technology to other projects involving other promising protein targets implicated in cancer.”


About ExpreS²ion Biotechnologies 
ExpreS²ion Biotechnologies has developed a complete proprietary protein expression platform, ExpreS², based on engineered Drosophila Schneider-2 (S2) cells to serve recombinant protein production needs in the biopharmaceutical industry as well as in academia.  ExpreS² allows quick access to proteins, excellent protein expression capability, scalability, applicability to high cell density production processes and regulatory friendliness. ExpreS²ion Biotechnologies is collaborating with teams developing manufacturing processes for malaria recombinant subunit vaccines. Expression of notoriously challenging malaria proteins in ExpreS² platform has enabled progress in these projects that address a huge medical need. ExpreS²ion Biotechnologies offers technology platform licensing opportunities for use in R&D and commercial protein manufacturing.

About the London Research Institute (Cancer Research UK)
Cancer Research UK (CR-UK) is a cancer research and awareness charity with the aim of reducing the number of deaths from cancer. The London Research Institute (LRI) is one of the CR-UK sponsored flagship research institutes and has an emphasis on basic research into the molecular and cellular mechanisms underlying development of the many different forms of cancer known today.

Contacts

Sancha Salgueiro, Ph.D., MBA
Vice President Business Development
ExpreS²ion Biotechnologies
Agern Allé 1, DK-2970 Hørsholm, Denmark
sas@expres2ionbio.com

Dr Svend Kjaer
Head of Protein Purification Facility (PPF), LRI
44, Lincoln's Inn Fields, Room 436-7
WC2A 3LY London
United Kingdom
Tel: +44 (0) 20 7269 3171

• apceth's first innovative cellular anti-cancer drug based on modified mesenchymal stem cells enters Phase I / II of clinical testing
• multicenter trial will start in Munich in Q2 2013
• already broad international interest from industry and academia

Munich, Germany, June 13, 2013 / B3C newswire / - As the first biopharmaceutical company worldwide, apceth GmbH & Co. KG with its headquarters and manufacturing sites in Munich and Ottobrunn (near Munich) has received approval to conduct a clinical cancer trial with its genetically modified, adult mesenchymal stem cells. This is an entirely new approach for the treatment of advanced types of cancer for which  there is currently no effective treatment available.

The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract. This innovative therapy is based on mesenchymal stem cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. The stem cells thus modified specifically target the tumor and the cytotoxic gene product is selectively activated at the site of the tumor or its metastases to increase local efficacy and to reduce systemic toxicity, one of the main problems of systemic chemotherapy. This unique principle is also applicable to other cancer types.

This clinical trial will be initiated at the University Hospital Grosshadern in Munich in the next few weeks in collaboration with experts from the National Center of Tumor Diseases (NCT) in Heidelberg and the Karolinska Institute in Stockholm.

There is already broad international interest in expanding this trial and further developing this innovative therapy option. John Marshall, Professor of Oncology and Director at the Lombardi Cancer Center of the Georgetown University in Washington, DC: "This is a very exciting new class of drugs based on adult stem cells delivering a true innovation for patients with advanced cancer. There is a clear unmet medical need for this and we are hopeful that we can begin testing in the US soon."

Also other leading cancer centers in the USA have already expressed their interest, such as the M.D. Anderson Cancer Center in Houston and the Fred Hutchinson Cancer Research Center in Seattle.

This to date unique and innovative approach in the treatment of cancer is part of apceth's corporate strategy of developing sustainable cell-based therapeutics. Other clinical trials are already testing the treatment of advanced vascular diseases, while other cellular drugs are under development.

Besides its own internal research and development programs, apceth also collaborates with international pharmaceutical and biotech companies, who are showing increasing interest in cell- and gene therapeutics as a next-generation treatment option and entering the emerging field of "regenerative medicine".

While apceth is already being supported by numerous national and international grants, the company has just concluded another round of financing of € 22 m from  their existing investors. This will enable apceth to further develop its innovative cellular therapeutics right up to the clinical testing stage.

About apceth
apceth is one of the leading European pioneers in the development, GMP manufacturing and clinical implementation of innovative (stem) cell-based therapies for the treatment of malignant and non-malignant diseases. apceth combines the principles of stem cell biology with groundbreaking technologies, applying the highest standards for GMP manufacturing, safety regulations and quality control according to the European Regulation for “Advanced Therapy Medicinal Products” (ATMPs). apceth provides novel cell therapy solutions for the treatment of clinical conditions for which no satisfactory treatment options are available to date. Its proven know-how in all aspects of ATMP pharmaceutical development and production (GMP manufacturing license in accordance with §13 and §20b AMG) also enable apceth to offer GMP/GCP-compliant contract manufacturing services for various ATMPs.
apceth was founded in 2007 as a start-up company and is privately owned by its founders and the Strüngmann Family Office as a private investor.

Contact:
Dr. Christine Günther, CEO
Prof. Dr. Ralf Huss, CSO
apceth GmbH & Co. KG
Max-Lebsche-Platz 30
D-81377 Munich
Germany
Phone: +49 (0)89-7009 608-0
Email:  contact@apceth.com

PCR test reduces time for mycoplasma detection from one month to one day

Penzberg, Germany, 13 June 2013 / B3C newswire / - Today Roche announced that the Canadian Health Authority has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. The test can replace conventional and time-consuming mycoplasma detection assays based on culture methods and was also accepted by the FDA end of last year.

Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret.

“Mycoplasma contamination represents a significant issue during biological drug production,” commented Ruedi Stoffel, Head of Custom Biotech at Roche. “Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products.”

A lecture about the MycoTOOL test will be offered at the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Munich.

About the MycoTOOL PCR Mycoplasma Detection Kit
The MycoTOOL PCR Mycoplasma Detection Kit provides all critical reagents for performing an easy to use sample preparation and PCR. It offers a high sensitivity (<1 CFU/ml for most isolates) and is compatible with a diverse spectrum of sample types as cellular matrices (Human cells, primary and continuous), canine cells, nonhuman primate cells, many different rodent cell types and cell-free matrices (culture supernatants of CHO or human stem cells, egg derived samples). It detects the broad panel of Mollicute species too, including over 150 species due to universal primer design (e.g. Mycoplasma, Spiroplasma, and Acholeplasma). 

The test also minimizes the risk of false negative and false positive test results: lysis controls of the matrix eliminate the risk of undetected intracellular Mycoplasma and positive controls verify potential PCR inhibition. Nucleic acid free reagents also prevent false positives and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

For use in quality control/manufacturing process only.

MYCOTOOL is a trademark of  Roche.
All other product names and trademarks are the property of their respective owners.

For further information please contact:

Roche Diagnostics
Dr. Claudia Schmitt
Phone: +49 8856 60 10210
Email :  claudia.schmitt.cs2@roche.com

Vienna, Austria, June 17, 2013 / B3C newswire / - AOP Orphan Pharmaceuticals AG today announced the spin off of its 80 % stake in Activartis GmbH, a Vienna-based biotech company with a strong platform for immune-based cancer vaccines, to a group of private investors. The dendritic cell-based technology for individualized tumor therapy developed by Activartis is well patented and represents a unique therapeutic approach. Clinical development is at an advanced stage for glioblastoma, an incurable disease, and data from a multicentric, prospective trial are expected soon. Beyond glioblastoma, other indications are being pursued, since the technology can be used for virtually any kind of tumor.

“This spin-off has to be seen in the context of our development and commercialization strategy at AOP Orphan and is a consequence of Elan’s offer to acquire AOP Orphan,” commented Rudolf Widmann, CEO of AOP Orphan. “The goal of the Elan scenario would have been to pursue a course of rapid territorial expansion and the addition of several new orphan projects. However, AOP was a minor part of Elan’s management strategy, which included four business proposals, the main one being a royalty-based deal. This strategy was turned down by Elan’s shareholders.”

“AOP Orphan is in a financial position to pursue its research programs as a stand-alone company, and the divestment of Activartis allows it to go for a separate global commercial business case for the cancer vaccine program. AOP Orphan will continue its research projects as planned in a timely manner and will launch at least two products within three years in the areas of hematology and cardiology.”

Besides the focus on its own pipeline, AOP Orphan is constantly seeking to add products to its commercialization platform. “We are a unique partner in our field for hospital and orphan products. Being a fully integrated company, we offer a one-stop solution in Central/Eastern Europe, the Middle East and the CIS countries. In order to achieve a successful commercialization strategy with medical marketing, selling and distribution in this field, it is essential to have our own staff on the ground to handle this complicated field”, Rudolf Widmann added. “Based on our successful approach, we are currently adding two further products to be launched in 2013 by partners in North America to our portfolio, and we are negotiating a highly interesting research program for a genetic disease in phase I/II”, continued Rudolf Widmann. “All in all, our fifteen years of experience and consistent, double-digit growth allows us to pursue our unique business strategy in the area of hospital and orphan products with a focus on emerging markets.”

Activartis Biotech GmbH: www.activartis.com

Contact
AOP Orphan Pharmaceuticals AG
Dr. Rudolf Widmann
Wilhelminenstraße 91/IIf
1160 Vienna/Austria
Phone +43 1 503 72 44-22
E-Mail rudolf.widmann@aoporphan.com

Hamburg/Regensburg, Germany, June 19, 2013 / B3C newswire / - Bionamics GmbH, the coordinator of the NEU² consortium,and Lophius Biosciences GmbH announced today that Lophius Biosciences has joined the NEU² program with a project addressing the development of T-Track® MS as a novel blood-based diagnostic test supporting the initial diagnosis of multiple sclerosis (MS) and enabling the monitoring of MS disease progression. This new project is to last for about two years with a funding of > 350.000 EUR proportionally supplied by The Federal Ministry of Education and Research (BMBF) under the BioPharma initiative.

Lophius Biosciences is a leading developer of innovative T cell based diagnostic test systems. One of the company’s platform technologies, the “Reverse T Cell Technology (RTT)”, represents a novel strategy for the diagnosis of T cell-mediated diseases. In contrast to available methods, RTT exploits the maturation processes induced in antigen presenting cells (APC) via a specific interaction with activated T helper (Th) cells thus representing an indirect measure for activated Th cells. Due to the high specificity of RTT for activated Th cells, the intended use of the RTT assay is the reliable detection of disease-specific activated Th cells as a novel biomarker for the diagnosis and monitoring of ongoing autoimmune diseases such as MS. The T-Track® MS test is aimed to fulfill unmet clinical needs offering a blood-based rapid and reliable differential diagnosis of MS complementary to the today’s state of the art clinical and MRT based diagnosis. Initial data from a collaboration between Lophius Biosciences and the Clinic and Policlinic for Neurology, University of Regensburg, and the Institute for Neuroimmunology and Clinical MS Research, Center for Molecular Neurobiology Hamburg, demonstrated preliminary clinical proof of principle for this MS test.

Dr. Michael Lutz and Prof. Dr. Ralf Wagner, Managing Directors of Lophius Biosciences commented: “We are very pleased to join the NEU² consortium. Both the opportunity to interact with leading experts in the MS field as well as the substantial funding will accelerate the development of our highly innovative T cell based diagnostic T-Track® MS test kit and help Lophius to initiate a broader clinical discovery and development program.”

Dr. Timm Jessen, CEO of Bionamics GmbH and founder of NEU², about the further expansion of the NEU² consortium: “With Lophius Biosciences we could attract an attractive new partner for the consortium. Its expertise in the diagnostic area will complement our expertises within NEU², also to the benefit of our current consortium members.”

 
About Lophius Biosciences GmbH
Lophius Biosciences GmbH, a German biotech company, is focusing on the development and marketing of innovative T-cell based diagnostic systems for the diagnosis and immunomonitoring in the fields of transplantation, infectious and autoimmune diseases. With its innovative products, the company also aims towards enabling therapy control and personalized treatment in the above fields of application.

About NEU²
The NEU² consortium, including, amongst others, Merck KGaA, Evotec AG, European ScreeningPort GmbH, Bionamics GmbH, and the University Medical Center Hamburg-Eppendorf was successful in the nationwide “BioPharma” strategy competition of The Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung – BMBF). This initiative aims to promote innovative partnerships between academic institutions, biotechnology and pharmaceutical companies in order to strengthen the pharmaceutical value chain in Germany. The NEU² consortium focuses on the development of novel therapies against neurological diseases with a specific focus on multiple sclerosis. The NEU² consortium is coordinated by Bionamics GmbH, an independent project management company and founder of NEU².

Contact:
Lophius Biosciences GmbH
Prof. Dr. Ralf Wagner
Josef-Engert-Str. 13
D-93053 Regensburg
Phone: +49 941 6309 19785
Email: ralf.wagner@lophius.de
www.lophius.de

Explore cutting-edge Nordic science and technologies in Stockholm Waterfront, 14-15 October 2013

Stockholm, Sweden, June 19, 2013 / B3C newswire / – SwedenBIO, in conjunction with its sister organisations in Denmark, Finland and Norway, invites you to attend Nordic Life Science Days 2013.

With focused academic resources and support from both the local investment community and government, the Nordic area is well placed to exhibit itself as a European life science hotspot.  Nordic Life Science Days will showcase this innovation and highlight the best of the region’s pharmaceutical, biotechnology, diagnostic, medtech and digital health industries.

Key presentations include:

Early Financing: Soft Money
Dr Björn Kull, Head of the Karolinska Institutet Grants Office, will chair a discussion on financing through the EU framework and Nordic public programmes which support innovative SMEs and philanthropic funding.

Open Innovation: Collaboration in the Precompetitive Space
Explore the European Commission’s Innovative Medicines Initiative featuring including case studies of successful public and private partnerships   which have discovered new medicines using open access research.

Nanomedicine: The Little Big Revolution
Explore the impact of nanotechnologies in medicine, illustrated by a series of presentations from leading experts in the field.

The European and Nordic Regulatory Landscape
Join The European Confederation of Pharmaceutical Entrepreneurs who will present the new EMA Transparency policy and its impact on access to data.

Personalised Medicine & BioBanks: Transforming Healthcare by Improving Health Outcomes
Insight on updates on regulatory and business issues, policy, as well as advances in the personalised medicine space.

Special Session on Stockholm Uppsala
Delve into Stockholm’s successful strategic collaborations – industry, academic and research opportunities. Presentations from Karolinska Institute, Royal Institute of Technology, Stockholm University, Science for Life Lab and the AstraZeneca Translational Science Center will showcase successful business development in Stockholm.

To register for your free media pass, please email gemma.howe@collegehill.com.

For more information and to register, please contact:

SwedenBIO
Karina Eskilsson
+46 8 213132
karina.eskilsson@swedenbio.com

College Hill Life Sciences
Gemma Howe
+44 (0) 20 7866 7860
gemma.howe@collegehill.com

Barcelona, Spain, June 19, 2013 / B3C newswire / – Medical diagnostics company STAT-Diagnostica has appointed Gérard Vaillant as chairman of the company’s board of directors. With more than three decades of senior leadership experience in the medical device and diagnostics sector, he brings expert industry perspective and guidance to the company as it prepares for the successive European and U.S. launches of its novel DiagCORE Near Patient Testing platform.

Vaillant is a career veteran of Johnson & Johnson Worldwide who has held of number of senior executive positions within the organization. These include managing director, Ortho Clinical Diagnostics France (1981 – 1987); vice president, Johnson & Johnson International (1987 – 1992); worldwide president, LifeScan, a Johnson & Johnson company (1992 – 1995); and company group chairman, Diagnostics Worldwide (1995 – 2004). He was also a member of Johnson & Johnson’s Medical Devices and Diagnostic Group Operating Committee until retiring in 2004. After his retirement from Johnson & Johnson, he remained active in the industry as board member of both Luminex and Vivacta. In addition to his current position with STAT-Diagnostica, Vaillant currently serves as chairman of the board of SafeOrthopaedics and PathoQuest; board member of Tecan CH; and venture partner at KLS Partners.

“We are very privileged to have Gérard join as the chairman of our board of directors,” said Jordi Carrerra, CEO and co-founder of STAT-Diagnostica. “His deep industry pedigree and proven track record of success will be invaluable to us as we move towards European and U.S. approval and commercialization of our DiagCORE platform.”

Vaillant joins STAT-Diagnostica following the company’s closing of a Series B financing round totaling 22.1 million USD/17 million Euros, which was announced May 6, 2013. Led by new investor Kurma Life Sciences Partners, the round also drew participation from new investors Idinvest; Boehringer Ingelheim Venture Fund; and, Caixa Capital Risc, the venture capital division of “la Caixa;” as well as existing investors Ysios Capital and Axis. The proceeds of the funding are being used to complete development of the company’s DiagCORE platform and clinical validation of its first products.

“The DiagCORE platform represents a significant breakthrough in the area of Near Patient Testing that stands to change clinical practice in the critical care setting,” said Vaillant. “In addition to its unique technology, STAT-Diagnostica’s excellent leadership and strong investor support are what attracted me to the board chairman position. I look forward to being part of the company’s future success.”

STAT-Diagnostica’s DiagCORE Near Patient Testing platform is designed to simplify and reduce time to results for the diagnosis of certain medical conditions. The in vitro diagnostic system is a versatile, easy-to-use platform that consolidates molecular and immunoassay techniques in a single device. The first clinical applications will be directed at infectious disease detection, antibiotic resistance determination and detection of biomarkers in critically ill patients.

STAT-Diagnostica’s DiagCORE platform not only offers multi-analyte and multi-sample capabilities, but it also reduces current diagnosis times (which can take up to several days) by providing results in less than 30 minutes. The system’s rapid performance will enable improved clinical decision making by medical practitioners, delivering better patient management with direct and indirect savings to the healthcare system.

 
About STAT-Diagnostica
Founded in 2010 in Barcelona, STAT-Diagnostica is focused on the development of Near Patient Testing solutions where fast and accurate diagnostic results are needed. Its DiagCORE in vitro diagnostic system is a versatile, easy-to-use platform that consolidates molecular and immunoassay techniques in a single device.

 
Contacts:

STAT-DIAGNOSTICA MEDIA CONTACT/U.S.: 
Laura Nobles
Nobles Global Communications
310-795-0497
laura@noblesgc.com   

STAT-DIAGNOSTICA MEDIA CONTACT/EUROPE:
Danièle Castle
Genevensis Communications
+41 79 202 6667
info@genevensis.com

Penzberg, Germany and Madison, WI, USA, June 21, 2013 / B3C newswire / - Roche today announced the global launch of the NimbleDesign tool, an online software  that enables customers to easily design optimized SeqCap EZ Choice Libraries in as little as one hour. The software’s industry-leading design algorithm offers an empirically optimized probe database allowing customers to obtain and review designs in an automated setting before making the purchase decision.

“NimbleDesign is based on years of target enrichment design experience from our bioinformatics experts,” said Thomas Schinecker, President of Roche Sequencing Solutions. “Following the very positive feedback we received from pilot users in selected regions we are excited to offer this software tool globally now. It marks another step in our ongoing efforts to improve the customer convenience of our target enrichment portfolio.”

The NimbleDesign tool enables customers to take full advantage of Roche’s superior SeqCap EZ library technology, delivering more efficient discovery of Single Nucleotide Polymorphisms and better uniform coverage than many other commercially available technologies. In addition, the easy-to-use interface offers the opportunity to develop multiple designs simultaneously with very quick turnaround time. Adding to the already improved customer convenience with the launch of SeqCap EZ Reagents earlier this year, the NimbleDesign tool further streamlines the design workflow and ordering process.

For more information about Roche NimbleGen, please visit www.nimblegen.com

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

For life science research only. Not for use in diagnostic procedures.

NIMBLEDESIGN, NIMBLEGEN and SEQCAP are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.

For further information please contact:

Roche Diagnostics
Dr. Claudia Schmitt
Phone: +49 8856 60 10210
Email: claudia.schmitt.cs2@roche.com

Free choice of purification conditions and enhanced protein stabilization in a pre-packed format                    

Penzberg, Germany, June 26, 2013 / B3C newswire / - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its new cOmplete His-Tag Purification Column for researchers performing histidine-tagged protein purification from lysates. The new column uses Roche’s proprietary nickel-chelate chemistry and is compatible with commonly used reducing agents (DTT), metalloproteinase inhibiting reagents such as EDTA, and different buffer and salt environments. This allows researchers to choose optimal buffer conditions for the target protein in a convenient pre-packed format.

“We have received very positive feedback from pilot users who appreciate the flexibility of being able to purify proteins under protein protecting conditions,” said Ruedi Stoffel, Head of Biochemical Reagents & Custom Biotech. “It enables our customers to apply any buffer required to obtain proteins of high purity, stability and function.”

Following the purification step, the new column does not require buffer exchange or resin recharging therefore avoiding a costly and time consuming process. In addition, the resin’s minimized nickel ion leakage not only reduces toxic nickel waste, but also stabilizes the target protein by preventing nickel ions from catalyzing protein oxidation.  

Thanks to the additional format, researchers can choose their preferred method of purification. The cOmplete His-Tag Purification Resin can be used for batch purification as well as on automated systems based on FPLC.  Pre-packed cOmplete His-Tag Purification Columns are available in two sizes (1 ml and 5 ml) and are compatible with standard instruments for protein purification.

Visit www.complete.roche.com for more information.

 
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

COMPLETE is a trademark of Roche.
All other product names and trademarks are the property of their respective owners.
For life science research only. Not for use in diagnostic procedures.

For further information please contact:

Roche Diagnostics
Dr. Claudia Schmitt
Phone: +49 8856 60 10210
Email: claudia.schmitt.cs2@roche.com

Vienna, Austria, July 1, 2013 / B3C newswire / - The US FDA notified the Austrian biotech company Activartis on Wednesday, June 26th, that Orphan Drug Designation (ODD) has been granted for its innovative Cancer Immunotherapy AV0113. The ODD applies specifically to the use of AV0113 for the treatment of malignant glioma, a very aggressive type of brain cancer. The European drug agency EMA already granted ODD at the end of last year.

In principle, Activartis’ AV0113 Cancer Immunotherapy may be used to fight any type of cancer. The individualized therapeutic technology is based on a patented procedure in which a cancer patient’s immune system is primed to fight the tumor and eventually control its growth. This concept is based on the use of Dendritic Cells, the key regulatory elements of the immune system, that are the same as the tumor tissue derived from the patient.

Active cancer immunotherapy based on Dendritic Cells
AV0113 activates the patient’s immune system, with tumor cells being identified on the basis of their antigens and destroyed. The therapy makes use of elements and mechanisms of the immune system and gets to work where these fail. As tumor cells are the body’s own tissue, the immune system does not normally identify them as dangerous. Activartis’ AV0113 Cancer Immunotherapy “tricks” Dendritic Cells and, consequently, a cancer patient’s immune system, into doing the right thing, i.e. to perceive the tumor as a threat and to trigger adequate defense mechanisms.

The Dendritic Cells are charged with tumor-derived antigens, determinants that distinguish a tumor cell from a normal cell. These antigens are processed by the Dendritic Cell and shuttled to the cell surface in order to present them to T-cells. This, however, is not sufficient to prime an immune response against the tumor antigens. The “trick” referred to above is contacting Dendritic Cells with a microbial danger signal. Certain molecules that are present in microorganisms but not in higher organisms signal to the Dendritic Cell the presence of a microbial invasion in its surroundings and hence danger to the organism.

As tumor cells originate from a cancer patient’s normal cells, they do not provide danger molecules which are recognized by the Dendritic Cell. The critical and unique part of Activartis’ AV0113 technology is exposing tumor antigen-charged Dendritic Cells to one of these danger molecules: lipopolysaccharides, the bacterial endotoxins. This causes the Dendritic Cell to assume a potently immune stimulatory and pro-inflammatory mode of action. Upon returning these Dendritic Cells to the patient, they activate tumor-specific T-cells, most importantly the so-called cytotoxic T-cells, which become able to recognize and destroy tumor cells.

Early results of the Activartis AV0113 trial reveal a promising trend.
At the beginning of 2013, Activartis completed recruitment of 78 brain cancer patients to a multi-centre, randomized, phase II clinical trial. This randomized study aims to deliver safety and efficacy data for the first time. Preliminary results presented at the AACR Annual Meeting (April 6-10, 2013, Washington) revealed a very promising trend suggesting a survival benefit of patients in the AV0113 treatment group compared to the randomized control group.

Confirmation of that trend is expected by the end of 2013. If the trend currently observed is confirmed, AV0113 is bound to become part of the standard therapy for GBM.

  
About Activartis
Activartis is a biotech company based in Vienna and was founded in 2003 as a spin-off of the St. Anna Children’s Cancer Research Institute, Vienna, Austria. Activartis is currently in phase II of clinical trials for a new kind of Cancer Immunotherapy. The therapeutic technology combines a completely new, patented approach, AV0113, which uses a bacterial danger signal together with the patient’s tumor antigens. The aim is to enable the immune system to gain control of the cancer.
Contact

Activartis Biotech GmbH
Mag. Daniela Gruber
Zimmermannplatz 10 I A-1090 Vienna, Austria
Phone: +43 664 3037178
E-Mail: daniela.gruber@activartis.com
Web: www.activartis.com

Supports Quality by Design process in biopharmaceutical development

Penzberg, Germany, 1 July 2013 / B3C newswire / - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its new alpha-2,6-Sialyltransferase for in vitro sialylation of glycoproteins and complex molecules as human monoclonal antibodies (mAbs). The enzyme, which is offered for research and pilot scale applications, is produced under animal-origin free conditions and offers a very high lot-to-lot consistency.       

“This launch is the first in a series to offer a complete glyco-engineering portfolio of key enzymes and activated sugars covering a broad spectrum of applications,” said Ruedi Stoffel, Head of Biochemical Reagents & Custom Biotech. “The initial feedback from bio-manufacturing customers showed that our continuous scientific and technical support throughout the up-scaling and development process differentiates Roche as a strong partner.”           

The alpha-2,6-Sialyltransferase delivers up to 95% bi-antennary sialylation of N-Glycan chains within 6 – 8 hours, a performance which is currently not offered by competitor products. It is based on a human genome sequence and expressed in mammalian expression systems. Over the coming months, Roche plans to complete the portfolio through launches of additional Sialyl-and Galactosyltransferases. 

Glycosylation is considered to be one of the main sources of biologics’ heterogeneity and is seen as a critical quality attribute by regulatory bodies. The implementation of Quality by Design Standards in the manufacturing of Active Pharmaceutical Ingredients such as mAbs with specific glycosylation patterns is expected to play a central role in future bio-manufacturing processes. 

 
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

All trademarks used or mentioned in this release are protected by law.

For further information please contact:

Roche Diagnostics
Dr Claudia Schmitt
Phone: +49 8856 60 10210
Email: claudia.schmitt.cs2@roche.com

Dortmund, Germany, July 2, 2013 / B3C newswire / - Protagen AG, Dortmund, divested its 100% subsidiary Protagen Protein Services GmbH (PPS), to Zukunftsfond Heilbronn. The company was spun out in January 2012 and continued the business of the former operational division Protein Services, which accumulated unique expertise in the GMP-compliant protein analytics over the years.

“The sale of this profitable service business to a potent investor with complementary portfolio companies secures a sustainable growth for PPS, an internationally renowned specialist for protein characterization and biosimilar comparability. On the other hand, the capital injection generated by this transaction is a solid mid-term financing opportunity for the Protagen strategy in the area of novel diagnostics, i.e. Dx and CDx, and enables to start the development of own products for this growing market immediately. With this step, Protagen positions itself as highly attractive target for new VC investors”, states Dr. Stefan Müllner, CEO.

About Protagen
PROTAGEN AG is a leading specialist in the development of novel diagnostic tests in autoimmune diseases. The company focuses its assay development programs on disease specific autoantibodies.
PROTAGEN expects to become the dominating provider for novel products in autoimmune-Dx and CDx.

Contact
Dr. Stefan Müllner
CEO
Protagen AG
Otto-Hahn-Str. 15
44227 Dortmund
T: +49 (0) 231 9742 6300
F: +49 (0) 231 9742 6301
bd@protagen.com

Press Inquiries
Dr. Georg Lautscham
CBO
Protagen AG
Otto-Hahn-Str. 15
44227 Dortmund
T:+49 (0) 231 9742 6300
F:+49 (0) 231 9742 6301
bd@protagen.com

• Innovative system for pre-use testing of bags after installation
• Accurate and reliable pressure drop technology

Goettingen, Germany / Aubagne, France, July 2, 2013 / B3C newswire / -Sartorius Stedim Biotech (SSB), a leading international equipment supplier for the pharma and biotech industries, has launched the new Sartocheck 4 plus Bag tester, the latest addition to its well-established Sartocheck line. The new system is the first device allowing reliable pre-use testing of single-use bioreactors after installation, based on the proven pressure decay measurement method. The Sartocheck 4 plus Bag tester directly responds to the market needs for increased security and quality assurance when single-use components are used. Designed for cell cultivation, single-use BIOSTAT CultiBag STR bioreactors with working volumes of 50 liters and 200 liters can now be conveniently tested by this new system. Later this year, the newly developed technology of this device will be extended to permit testing of 500-liter and 1,000-liter BIOSTAT CultiBag STR systems.

The Sartocheck 4 plus Bag tester performs a pre-use test of the entire bioreactor, including tubing. This device is capable of detecting typical leaks that might have been caused by operator handling errors upon installation of a bioreactor. Therefore, the bag tester is ideal for eliminating the risk of filling a defective single-use bioreactor with expensive cell cultures. The reason is its unique, patented fleece, which is inserted between the plastic film of the BIOSTAT CultiBag STR and the bag holding device of the tester. This fleece acts as a porous spacer, preventing direct contact between the bag and the smooth stainless steel surface of the holder. In addition, the fleece substantially reduces environmental heat transfer and, most importantly, eliminates the effects of masking of any potential pinholes. The high accuracy of the Sartocheck 4 plus Bag tester in measuring the pressure drop, along with its patented fleece technology, provides unrivaled reliability and reproducibility for testing.

The Sartocheck 4 plus Bag tester is an important contribution by Sartorius Stedim Biotech towards enhancing risk mitigation for single-use equipment in biopharmaceutical manufacturing.

Image File:
SSB’s Sartocheck 4 plus Bag tester performs a pre-use test of the entire bioreactor.
Link for downloading: 
 http://www.sartorius.com/fileadmin/media/global/company/sartocheck_4_bag_tester.jpg

A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions”. Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs around 3,000 people and in 2012 earned sales revenue of 544 million euros.

Press contact
Dominic Grone
Sartorius Group Corporate Communications
Phone: +49.(0)551. 308.3324
Fax: +49.(0)551.308.3410
dominic.grone@sartorius.com

Adding iron and phosphate tests to Cedex Bio test menu 

Penzberg, Germany, July 3, 2013 / B3C newswire / - Roche today announced the launch of new metabolite-testing reagent sets to determine the concentration of iron and phosphate, two parameters relevant for cell growth and productivity during fermentation processes. The tests are designed for applications in research and bio-manufacturing process development and will allow the measurement of iron (complexed iron /Fe3+ ions) and phosphate on Cedex Bio instruments.

“The new tests ideally expand our metabolite testing portfolio for mammalian cell fermentation analytics. It is currently the most comprehensive portfolio combining iron and phosphate testing with other relevant parameters such as IgG, LDH and other standard metabolites,” said Ruedi Stoffel, Head of Biochemical Reagents and Custom Biotech. “Thanks to their reliability, precision, and ease of use, our Cedex instruments and the new testing portfolio are perfectly designed to optimize process development and monitoring of bio-pharmaceutical production particularly when using chemically defined media. The rapidly increasing customer base of our Cedex instruments will benefit from our continuously expanding testing portfolio.”

The new tests can be easily installed by barcode reading through the customer supporting the flexible testing concept. Offered as liquid-stable formulation, they are ready for use and do not require manual dilution or pipetting steps. With their increased precision, accuracy and long calibration intervals, the new iron and phosphate tests offer cost-effective and convenient testing with less hands-on time for users.

 
About the Cedex product family
Roche supplies reliable systems for all types of in-process control of fermentation processes using mammalian and microbial cells in the form of its Cedex Bio Analyzer for low-throughput and its new Cedex Bio HT Analyzer for high-throughput applications. To obtain even more comprehensive in-process manufacturing information, Roche recommends combining its Cedex Bio instruments with its Cedex HiRes Cell Analyzers.  

By minimising hands-on time, the Cedex Bio HT Analyzer demonstrates greater precision, sensitivity and linearity than instruments that use membrane-based technology. It includes three different measuring methods, enabling the analysis of IgG (immunoglobulin G) and LDH (lactate dehydrogenase), as well as various substrates and metabolites such as glutamate, glutamine, sodium, potassium, glucose, lactate and ammonia, plus the newly launched iron and phosphate tests.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

CEDEX is a trademark of Roche.
For use in quality control/manufacturing processes only.

For further information please contact:

Roche Diagnostics
Dr Claudia Schmitt
Phone: +49 8856 60 10210
Email : claudia.schmitt.cs2@roche.com

Sartorius Stedim Biotech presents first App for Membrane Chromatography

Goettingen, Germany | Aubagne, France, July 3, 2013 / B3C newswire / – According to the motto “Sartobind goes mobile” Sartorius Stedim Biotech introduces its first smartphone application (App) for the Sartobind membrane adsorber portfolio. The Sartobind App provides mobile users with useful selection and training tools to complement the product portfolio, and provides links to all the literature available in the digital library.

The product finder feature enables the beginners and experts to select the appropriate membranes required for capture chromatography that is utilized in binding viruses or large proteins versus flow-through polishing processes, which is used to remove DNA, host cell proteins and other charged contaminants from a target molecule. Those new to chromatography will benefit from using the Ion Exchange Calculator to better understand the interplay between pH and the isoelectric point of the protein of interest. More experienced users will appreciate the flexible search function for downloading application notes and other literature by search parameters related to target molecule, membrane type, device format and scale. Other valuable features for all users are a flow rate calculator, an isoelectric point list for proteins and viruses, a comprehensive chromatography glossary, and a FAQ document.

The English-language Web App requires direct access to the Internet. It has been optimized for Apple iPhones, but will run on many android smartphones. The following link can be used to download this App on your smartphone: http://app.sartorius.com/sartobind/.

Image Files:

  
For high resolution, please click on image.

Links for downloading:

http://www.sartorius.com/fileadmin/media/global/company/sartobind_app_1.jpg
http://www.sartorius.com/fileadmin/media/global/company/sartobind_app_2.jpg
http://www.sartorius.com/fileadmin/media/global/company/sartobind_app_3.jpg
http://www.sartorius.com/fileadmin/media/global/company/sartobind.jpg

A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions”. Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs around 3,000 people and in 2012 earned sales revenue of
544 million euros.

Press contact:
Dominic Grone
Sartorius Group Corporate Communications
Phone: +49.(0)551. 308.3324
Fax: +49.(0)551.308.3572
dominic.grone@sartorius.com

Cologne, Germany, July 9, 2013 / B3C newswire / -Blackfield announced today that it has entered a collaboration with AstraZeneca, a global biopharmaceutical company. Under the terms of the agreement, Blackfield will apply its genomics technologies and computational biology capabilities to validate preclinical models in support of one of AstraZeneca’s oncology drug development programs. The collaboration with AstraZeneca marks Blackfield’s fourth partnership with a major pharmaceutical company within one year of starting up. Earlier this year Blackfield entered service agreements with Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson), Merck KGaA and Boehringer Ingelheim.

Professor Roman Thomas, Blackfield’s Scientific Director said: “We are pleased to help AstraZeneca make more informed decisions in the clinical stage of their compound development. By applying our unique background in genomics, cancer medicine, and computational biology, Blackfield mines genomic information to support our clients in developing targeted cancer therapies. We are delighted that Blackfield’s position as a preferred scientific partner for global pharma companies has been confirmed this quickly. It demonstrates that our science-driven partnering approach that leverages genome analysis and oncology experience to offer expertise from one source is of highest value to the pharmaceutical industry.”

About Blackfield
Blackfield is a Germany-based company that was founded by renowned cancer researchers Axel Ullrich and Roman Thomas. Professor Thomas heads the Department of Translational Genomics at the University of Cologne. His lab strives to identify, characterize and validate novel targets for therapy in cancer and to develop novel technology for cancer genome diagnostics. Blackfield offers a broad spectrum of genomics and sequencing-based technologies; the main product is a customizable multigene assay to test tumor samples for genome alterations (mutations, insertions/deletions, amplifications, rearrangements) in more than 300 cancer-relevant genes, thus supporting patient stratification and response prediction. With all its services, Blackfield offers outstanding computational biology expertise and technology to support the analysis and interpretation of genomics datasets. Blackfield’s business model is highly flexible and centered on customized collaborations to find optimized solutions that transfer the latest scientific findings and target specific know-how from the lab to the clinic.

Contact:

Dr. Jutta Fritz
Blackfield AG
Email: info@blackfield.de
Phone: +49 221 / 88 82 38-15

Ready-to-submit documentation for the USA and Europe, and now Japan 

Ravensburg, Germany, July 9, 2013 / B3C newswire / – Vetter has broadened its portfolio for lyophilized substances. The contract development and manufacturing organization (CDMO) is now offering its filling service for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data. Vetter’s stability data and bracketing concept allows a longer shelf life for drugs, and high flexibility while defining the filling volume. Vetter can also offer ready-to-submit documents for the sWFI service in Common Technical Document (CTD) format.  This can considerably abbreviate the approval process.

Because innovative drugs are becoming increasingly more sensitive to environmental influences, they are often lyophilized to increase their shelf life. In a freeze-dried state, these drugs maintain their bioactivity for longer periods of time. However, before being administered they have to be reconstituted and dissolved in a solvent, after which they are ready for injection. The filling service for syringes with sterile water-for-injection (sWFI) is Vetter’s intelligent solution for safe and simple handling of the reconstitution process. The system contains the exact defined amount of solvent required by the customer in order to produce the required dosage. This helps to assure patients that they will receive the exact amount of substance needed.

Vetter’s filling service for sWFI syringes is an ideal complement to lyophilized drugs in vials and is available in 1.5 ml formats with a volume of 0.5 ml to 1.3 ml, as well as a 3 ml format with a volume of 1.4 ml to 3.0 ml. The syringe features Vetter’s V-OVS^® tamper-evident closure, which is designed to give a prefilled syringe system effective protection features. Vetter supports its sWFI filling service with 5 years of stability data and can manufacture batches of up to 120,000 / 140,000 pieces. For the sWFI syringes, Vetter has ICH compliant and ready-to-submit documentation for the USA, Europe, and Japan. Validation and stability data according to USP, Ph.Eur., Ph.J., and ICH guidelines are also available.

“Lyophilized drugs are an international growth segment for CDMO’s,” says Peter Soelkner, Managing Director of Vetter. "An ever greater number of manufacturers are looking for options to enable a safe and simple administration of these drugs. Our filling service for WFI syringes represents a reliable and patient-friendly solution offering our customers high-flexibility due to Vetter’s bracketing concept, and fast time-to-market by using the ready-to-submit documents. In addition to documents for approval in the USA and Europe, we also have all the necessary documentation for Japan available for pharmaceutical and biotech firms, which can considerably abridge the approval process.”

 
Caption: Vetter’s 1.5 ml sterile Water for Injection (sWFI) syringe
For high resolution please click on the image.

About Vetter
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.

Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3706
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com