Articles by Ken Green - BioPharm International



Articles by Ken Green

Ken Green

Principal Scientist at Amgen, Inc.

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
May 1, 2013

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances
August 1, 2011

The authors re-examine environmental controls in the context of technical advances in manufacturing.

Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit Operations
June 1, 2008

Process-modeling tools can ensure smooth tech transfer.



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