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| home > ebr > autumn 2002 > strategic process development to complement commercial and regulatory requirements |
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European BioPharmaceutical Review
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| Commercial Pressures
The need to take products through to the market rapidly is driven by patent expiry and the loss of time on the market at peak sales. The need to recoup costs in an increasingly price-conscious market also drives cost containment during the development of the product. There is still a need to meet the standards set out by the regulatory authorities. The approach to the optimal route to the market differs between small and large companies. A large profitable organisation is more likely to focus on speed to market, but may not have the co-ordinated infrastructure to direct early development towards this aim. A small company will be concerned with rapid progression into Phase I and II trials and compromises are inevitable. In either case, the early phase process may not be applicable to large-scale or commercial manufacture.The rapid development of a process for use in Phase I or II can lead to considerable, lengthy re-development of the process when facing the requirements of process validation for Phase III. |
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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