ACKNOWLEDGMENTS
The authors thank the following for their input by reviewing the article and providing benchmark information: Thomas Dazkowski,
vice-president of process technology, healthcare at Bayer Technology Services; Raul Santiago, head of engineering at BMS;
Steven Kreisher, head of engineering at Janssen; Paul Smock, head of quality at MedImmune; Petra Wawra, manager, downstream
operations at Merck Serono; Carl Johnson, principal engineer at Genentech; Benno Steinweg, head of technical compliance at
Sanofi; Thomas Sauer, head of new products and industrialization at Sanofi; and Beth Junker, senior director bioprocess R&D
at Merck. We also thank Marc Reifferscheid, Rene Fischer, and Markus Schneider from Novartis for their significant contribution
during the benchmarking phase of the collaboration.
Simon Chalk* is director at BioPhorum Operations Group, Ryan Taber is business unit leader, biologics manufacturing at Abbott, Scott Probst is a principal technology specialist at Bayer Technology Services, Paul Gil is in global regulatory affairs at Bayer HealthCare, Tim Palberg is a venture manager at Bayer HealthCare, Matt Kennedy is manager, process engineering at GlaxoSmithKline, Joe Rogalewicz is a quality director at GlaxoSmithKline, Jeff Johnson is engineering director, Global Engineering Services at Merck, and Ken Green is director, bioprocessing at Pfizer. *To whom correspondance should be addressed, simon@biophorum.com
.
REFERENCES
1. ISO, ISO 14644-1, Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness Cleanroom Standards (1999).
2. ISPE, Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 6: Biopharmaceuticals (ISPE, June 2004, Glossary, Updated June 23, 2010).
|
