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PDA Offers Help in Applying Single-Use Systems to Bio/Pharma Operations
Date:10/16/2014

BETHESDA, Md., Oct. 16, 2014 /PRNewswire-USNewswire/ -- 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

Duncan Low, Ph.D., AmgenMorten Munk, Team Co-Chair, CMC Biologics

Ingrid Markovic, Ph.D., U.S. FDAStephen Brown, Ph.D., BE Vaccines

Jerold Martin, Pall Life SciencesJeffrey Carter, Ph.D., GE Healthcare

Paul Priebe, Sartorius Stedim BiotechNiels Guldager, NNE Pharmaplan

Christopher J. Smalley, Ph.D., Merck & CoChristian Julien, Meissner Filtration Products, Inc.

Russell Wong, Ph.D., Bayer HealthCareContributors to the document were:

Robin Alonso, Genentech

James Robinson, Lachman ConsultantsEberhard Bill, Ph.D., Boehringer Ingelheim

Hillary Russak, GenentechOki Dzivenu, GE Healthcare

Robert Shaw, Finvector—FVT LtdBill Hartzel, Catalent Pharma Solutions

Ken Baker, NewAge Industries Inc.Eric Isberg, ATMI

Sally Kline, Ph.D., AmgenMaik Jornitz, G-Con

Mani Krishnan, EMD MilliporeMichael Kraich, Ph.D., Boehringer Ingelheim

Jessica Frantz, Sartorius Stedim BiotechAbout PDA – Connecting People, Science and Regulation®The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.

Media Inquiries: Walt Morris, 301-656-5900, x. 148; morris@pda.org

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SOURCE Parenteral Drug Association
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