Manufacturing, Aseptic Processing

Jul 01, 2006
BioPharm International
By BioPharm International Editors
Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.
Jun 27, 2006
BioPharm International
On August 12, 2003, Johnson & Johnson began recalling certain batches of its anemia drug, Eprex (epoetin alfa, sold as Procrit in the US), in most countries outside of the United States.
Jun 27, 2006
BioPharm International
By BioPharm International Editors
A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.
Jun 01, 2006
BioPharm International
Disposables can be used for media preparation, clarification, filling in downstream processes . . .
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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