BioPharm International Supplements, November 2007 - BioPharm International

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BioPharm International Supplements, November 2007
Articles
Single-Use Technologies—A Contract Biomanufacturer's Perspective
By Imara Charles , Janet Lee , Yamuna Dasarathy
One of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.
Design and Testing of a Prototype Large-Scale Bag Freeze–Thaw System
By Philippe Lam , Samir Sane
A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank.
Antibody Purification with an Integrated Disposable Assembly
By Gazala Khan-Koticha , Lisa Nakakihara , Lee Tucker , John Scarcella , Eric Rudolph
Comparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.
Disposable Process for cGMP Manufacture of Plasmid DNA
By Paul Lloyd-Evans , Denise A. Phillips , Antony C.C. Wright , R. Keith Williams
Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.
A Next Step in Implementing Disposables: Transfer Lines
By John Boehm
Single-use systems reduce maintenance and capital expense by eliminating expensive vessels, valves, and sanitary piping assemblies.

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