BioPharm International Supplements, November 2010 - BioPharm International

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BioPharm International Supplements, November 2010
Peer-Reviewed Research
Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal Antibody
By Emmanuelle Cameau , Georges De Abreu , Alain Desgeorges, PhD , Henri Kornmann, PhD , Elodie Charbaut, PhD
Despite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
Regulatory Expectations and Consensus Industry Recommendations for Extractables Testing of Single-Use Process Equipment
By Jerold Martin
BPSA eases confusion over extractables and leachables testing through guides.
Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical Manufacturing
By Keqiang Shen , Be Van Vu , Nikunj Dani , Bryan Fluke , Lei Xue , David W. Clark
A case study evaluates the performance, control of operations, productivity, and cost savings of a single-use system.
An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical Applications
By Michael LaBreck , Mark Perreault
Single-use TFF offers the greatest savings in clinical and contract manufacturing, where the scale is low and changeovers are frequent.
Disposable Bioreactors for Viral Vaccine Production: Challenges and Opportunities
By Jean-François Chaubard , Sandrine Dessoy , Yves Ghislain , Pascal Gerkens, PhD , Benoit Barbier , Raphael Battisti , Ludovic Peeters
Switching to single-use bioreactors can have financial and performance benefits.

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