Articles by Ken Green

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities

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

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

Process-modeling tools can ensure smooth technology transfer of microbial and mammalian processes from bench to commercial scale.
Jun 1, 2008
By: Anurag S. Rathore, PhD, Ken Green, Yas Hashimura, Greg Nyberg

Process-modeling tools can ensure smooth tech transfer.