Diosynth Biotechnology Announces Agreement with Talecris Biotherapeutics for Process Development and Clinical Production of Recombinant Plasminogen
- Category: Proteins and Peptides
- Published on Tuesday, 03 April 2007 03:00
- Hits: 3082
RESEARCH TRIANGLE PARK, NC, USA | Apr 2, 2007 | Diosynth Biotechnology announced today that it has signed an agreement with Talecris Biotherapeutics for process development activities and cGMP production of clinical trial material for a unique form of recombinant Plasminogen. Recombinant Plasminogen is an intermediate material used in the manufacture of recombinant Plasmin, a second-generation therapy Talecris is developing for both ophthalmic and thrombolytic indications.
"We are pleased to have the opportunity to work with Talecris as they are a dynamic, global company with an increasing interest in the development of recombinant therapeutics,” said Jacques van Kimmenaede, President of Diosynth Biotechnology. Van Kimmenaede added, “We look forward to interactions with our RTP neighbor as we develop the manufacturing process for recombinant Plasminogen and produce their clinical trial material.”
“We were confident in the selection of Diosynth Biotechnology as our CMO," said Steve Petteway, Senior Vice President, Research & Development, Talecris Biotherapeutics. “They have a strong track record in process development and cGMP production of both clinical and commercial products, which demonstrates a level of excellence in manufacturing and quality systems. Additionally, they have accomplished this across a range of molecule classes that goes beyond a typical CMO offering.”
Diosynth Biotechnology offers contract cGMP manufacturing of biopharmaceuticals. The company serves its customers by applying a full set of capabilities that range from cell line development to clinical and commercial manufacturing of both fermentation and cell culture derived drug substance, through fill and finish of drug product.
Diosynth Biotechnology is a division of Organon that supplies contract manufacturing services for the global biotechnology industry. The company has an 80-year heritage in biologics manufacturing and is a global leader in technology-driven process development and cGMP manufacturing of recombinant proteins, monoclonal antibodies and peptides. We help our customers succeed by developing scalable and robust processes and by driving products efficiently, rapidly and cost-effectively from preclinical development to market supply. Diosynth Biotechnology serves pharmaceutical and biopharmaceutical customers globally and operates FDA-, Health Canada- and EMEA-inspected cGMP manufacturing facilities in Research Triangle Park, NC USA, and Oss, the Netherlands. Diosynth Biotechnology is part of Akzo Nobel's human healthcare business unit Organon. The Akzo Nobel Safe Harbor Statement (below) applies to this press release. For more information: http://www.diosynthbiotechnology.com
Safe Harbor Statement (a)
This press release may contain statements which address such key issues as Akzo Nobel’s growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the company’s corporate website www.akzonobel.com. The 2006 Annual Report on Form 20-F will be available in the second quarter of 2007.
(a) Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
SOURCE: Diosynth Biotechnology