Manufacturing, Aseptic Processing

Apr 01, 2006
BioPharm International
In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.
Feb 01, 2006
BioPharm International
Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.
Sep 01, 2003
BioPharm International
By BioPharm International Editors
The author shares a case example that applies an eight-step structured approach to the front-end engineering of a vaccine R&D fill-and-finish facility project. Assumptions, issues, action items, owner interface, and interdisciplinary coordination are covered to meet the challenges of timing, technology, compliance, and cost.
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