Articles by Ken Green

Ken Green

Principal Scientist at Amgen, Inc.

Articles

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
May 1, 2013
By: Simon Chalk , Scott Probst , Ken Green , Russell Moser , Frank Urbanski , Matthew Zicaro , Paul Smock , Larry Pranzo , Liz Dooley , Phil McDuff

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
By: Simon Chalk , Scott Probst , Paul Gil , Tim Palberg , Matt Kennedy , Joe Rogalewicz , Jeff Johnson , Ken Green

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
By: Anurag S. Rathore, PhD , Ken Green , Yas Hashimura , Greg Nyberg

Process-modeling tools can ensure smooth tech transfer.