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About This Item
Full Description
The biopharmaceutical industry has adapted to reflect available technologies, products with more focused patient populations, regulatory conditions, and continued pressures on costs. The Guide develops concepts to reflect how these changes affect Biopharmaceutical Facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.
The Guide emphasizes the use of closed systems as an approach to mitigating risks associated with the production of biopharmaceuticals.
Concepts presented within the Guide apply to different scales of operation, from individual liters to tens of thousands of liters. The Guide applies to new Clinical and Commercial CGMP production facilities for the development and manufacture of biopharmaceutical Active Pharmaceutical Ingredients (or Drug Substances).
Types of Drug Substances considered in this Guide include:
- protein therapeutics
- synthetic proteins
- polypeptides
- monoclonal antibodies
- vaccines
- biopharmaceutical Drug Substances isolated from tissues or body fluids
- transgenic biopharmaceutical Drug Substances
- gene therapy biopharmaceutical Drug Substances
- stem cells
This Guide is not intended to be used in the retrofit of older facilities; however, the execution of these concepts and strategies can be evaluated and implemented as it benefits production in a major modification of an existing facility.
Document History
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ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
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ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities- Historical Version