Monday, 30 April 2018

Phase Appropriate GMP for Biological Processes


A new book of interest: "Phase Appropriate GMP for Biological Processes:  Pre-clinical to Commercial Production", edited by Trevor Deeks.

The book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process.

Details of the book can be found at the PDA bookstore.

I have contributed two chapters:

Sandle, T. (2018) Microbiological Control and Testing for Phase Appropriate GMP. In Deeks, T. (Ed.) Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production, PDA / DHI Books, Arlington Heights, IL, U.S.

Sandle, T. (2018) Sterility Assurance in Early Phase Development. In Deeks, T. (Ed.) Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production, PDA / DHI Books, Arlington Heights, IL, U.S.

Posted by Dr. Tim Sandle

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