Abstract
Managing quality control (QC)/quality assurance (QA) is a challenge in biopharmaceutical manufacture and product release. While many of the quality systems which are applied to biopharmaceutical products are also employed in the control of chemical pharmaceutical products and traditional biological products, there are special QC/QA concerns associated with the control of biopharmaceutical products. The main component that is used in the production process is a living organism which has been genetically altered. The manufacturing processes used to produce biopharmaceuticals, whether recombinant DNA methods or hybridoma technologies, can be fairly complicated with extended production times. Adequate in-process testing, thorough process validation, and a comprehensive assessment of final product quality using a complete battery of analytical methodologies, is needed to demonstrate lot-to-lot consistency. How a biopharmaceutical company that is not a fully integrated pharmaceutical company, but instead either a loosely structured or even virtual (fully contracted out operations), pharmaceutical company, can manage these quality needs will be presented.
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