Article
Managing CMOs With Complementary Capabilities
May 17, 2010
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•Article: Managing CMOs With Complementary Capabilities
By Patheon Inc.
After an innovator organization decides to take a candidate drug through to clinical trials, it faces key decisions relating to managing the production and supply of material to the clinic. The requirements for progressing a drug through to clinical trials include analytical characterization of the molecule, production of drug substance, manufacture of drug product, analytical method development and validation, and formulation development of drug substance and drug product.
For parenteral preparations, the drug substance will be provided in a liquid form, which may need to be reformulated for the drug product. With other more conventional dosage forms, the drug substance may have to be supplied as a solid for use in manufacture. This raises two questions for the innovator organization.
Analytical methods for nonparenteral dosage forms will almost certainly need to be redeveloped and revalidated. In all likelihood, the formulation will not be readily compatible with the methods commonly used for protein analysis. There is a strong possibility of matrix components inter fering with the analysis. The development of a suitable method of extraction of the drug substance from the matrix also may be required. The innovator organization may be faced with a choice in relation to where the method (re-)development and (re-)validation activities for drug product are now best carried out.
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•Article: Managing CMOs With Complementary Capabilities
