Avid Bioservices Executive Explains How to Select the Right CMO to Achieve Biosimilar Success.--Attend Avid SVP SVP S'il Vous Plaît (French: Please) SVP Senior Vice President SVP Schweizerische Volkspartei (Swiss People~s Party) SVP Society of Vertebrate Paleontology SVP Social Venture Partners SVP St Vincent de Paul Richard Richieri's Presentation Wednesday at 4:30 pm at GEN Theater at BIO 2009 International Convention, Booth #5807-- TUSTIN, Calif. & ATLANTA -- Avid Bioservices, Inc., a leading provider of cGMP contract manufacturing of biologics and other key services, today announced that senior vice president Richard Richieri will give a presentation at the 2009 BIO International Convention highlighting the key role contract manufacturing organizations (CMOs) can play in achieving market exclusivity for biosimilar products. In his talk, Mr. Richieri will describe the many important parameters developers of biosimilars must consider in selecting a CMO CMO See: Collateralized mortgage obligation CMO See collateralized mortgage obligation (CMO). and provide specific guidance on how to evaluate their suitability. The talk, "The Importance of CMO Partnership for Bio-Similar Production: Market Exclusivity," will be presented at the GEN Theater, Booth #5807, May 20 at 4:30 pm EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . Under proposed federal legislation promoting the development of biosimilar versions of marketed protein drugs, manufacturing will play a critical role in determining whether and when biosimilar candidates will obtain regulatory approval. Timing is particularly important since the proposed legislation awards a period of market exclusivity only to the first company to demonstrate product interchangeability in·ter·change·a·ble adj. That can be interchanged: interchangeable items of clothing; interchangeable automotive parts. in with the marketed product. Mr. Richieri notes, "My talk will illustrate how an experienced, quality-focused CMO can be critical to achieving timely approval and will help biosimilar developers unravel the many factors they must assess to ensure their CMO partner helps maximize their chances for success." Mr. Richieri will focus on how to evaluate critical CMO capabilities, including: * Facility suitability and capability--does the CMO have experience with similar products? * Is the requisite capacity in place and available? Are there flexible options? * What is the status of quality systems and in-house testing capabilities? * How good are process and assay validation procedures and what is their record of success? * Is there a robust regulatory and inspection history? * Are personnel at all levels experienced? What is the status of training requirements? * Are there options throughout to ensure reasonable process and production costs? * Does the corporate culture promote excellence and a collaborative spirit? Mr. Richieri added, "Biosimilar developers should understand that CMO relationships can impact their success in fundamental ways. It is therefore well worth the effort to become educated on how to optimize the selection of a CMO partner, and I look forward to sharing our insights as an innovative contract manufacturer and process developer with successful experience serving a growing roster of clients and products." A copy of Mr. Richieri's presentation will be available on the Avid website beginning May 21, 2009 at www.avidbio.com. Avid Bioservices is a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM PPHM Peregrine Pharmaceuticals, Inc (stock symbol) pphm Parts Per Hundred Million ). Avid is exhibiting at Booth #5801 and hosting an open reception on May 19 beginning at 5:00 pm EDT. About Avid Bioservices Avid Bioservices provides a comprehensive range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid manufactures cGMP commercial product, as well as clinical supplies for all phases of clinical trials. The company's comprehensive range of cGMP services includes cell banking, stability testing Stability testing can refer to:
1. the act of pouring over or through, especially the passage of a fluid through the vessels of a specific organ. 2. a liquid poured over or through an organ or tissue. modes. For more information about Avid, visit www.avidbio.com. About Peregrine Pharmaceuticals Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections viral infection, n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. . The company is pursuing three separate clinical programs in cancer and hepatitis C virus
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