Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing now available
Bethesda, Md., October 16, 2014 – The Parenteral Drug Association (PDA) announces the completion of guidance on the application of single-use, or disposable , systems in the manufacturing operations for pharmaceutical and biopharmaceutical products with the publication of Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.
Single-use technology, often described as single-use systems (SUS) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, life-saving drugs. This success, however, is very much dependent on how effectively the industry approaches the development and implementation of single-use technology.
PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing is intended to provide the reader with critical concepts or points to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.
“PDA thanks the task force team of volunteers that produced Technical Report No. 66 for their hard work in ensuring that the document represents the most up-to-date best practices in the application of single-use systems,” said PDA President Richard Johnson. “The task force team of authors and contributors was diverse, representing large and small drug manufacturers, vendors to the industry and even the U.S. FDA.”
The team of authors was:
- Robert Repetto, Team Co-Chair, Pfizer
- Morten Munk, Team Co-Chair, CMC Biologics
- Stephen Brown, Ph.D., BE Vaccines
- Jeffrey Carter, Ph.D., GE Healthcare
- Niels Guldager, NNE Pharmaplan
- Christian Julien, Meissner Filtration Products, Inc.
- Duncan Low, Ph.D., Amgen
- Ingrid Markovic, Ph.D., U.S. FDA
- Jerold Martin, Pall Life Sciences
- Paul Priebe, Sartorius Stedim Biotech
- Christopher J. Smalley, Ph.D., Merck & Co
- Russell Wong, Ph.D., Bayer HealthCare
Contributors to the document were:
- Robin Alonso, Genentech
- Eberhard Bill, Ph.D., Boehringer Ingelheim
- Oki Dzivenu, GE Healthcare
- Bill Hartzel, Catalent Pharma Solutions
- Eric Isberg, ATMI
- Maik Jornitz, G-Con
- Michael Kraich, Ph.D., Boehringer Ingelheim
- James Robinson, Lachman Consultants
- Hillary Russak, Genentech
- Robert Shaw, Finvector—FVT Ltd
- Ken Baker, NewAge Industries Inc.
- Sally Kline, Ph.D., Amgen
- Mani Krishnan, EMD Millipore
- Jessica Frantz, Sartorius Stedim Biotech