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. -

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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.


BioPharm International
Volume 24, Issue 7, pp. 44-60

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,
.

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).


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