Articles on chromatography, filtration, scale-up for proteins, MAbs, vaccines - BioPharm International

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Downstream Processing
The separation and purification steps of biotech processing, including chromatography and filtration. Vaccine and monoclonal antibody (MAb) manufacturing are also found here.

New Binary Gas Integrity Test Improves Membrane Quality Assurance

April 1, 2011

The authors developed a test for defects in filter membranes.

Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media

November 1, 2010

Making chemically defined media work.

Podcast: Answers to Your Questions about QbD

October 11, 2010

Hundreds of listeners tuned into our recent web seminar on Quality by Design, and we didn?t have time to answer all their questions. Fortunately, our speakers gathered to answer the common questions in this podcast.

Characterization of Aluminum Hydroxide Gel and Oil-in-Water Emulsion Formulations Containing CpG ODNs

October 2, 2010

Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Release and Stability Testing Programs for a Novel Virus-Like Particle Vaccine

October 2, 2010

Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.

An Alternative Platform for Rapid Production of Effective Subunit Vaccines

October 2, 2010

Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter Qualification

October 2, 2010

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.

Regulatory Challenges Impede the Adoption of New Downstream Processing Technologies

October 1, 2010

Can vendor—user partnerships overcome the typical wait-and-see attitude toward new technologies?

Design Space Development for Lyophilization Using DOE and Process Modeling

September 1, 2010

Develop a relevant design space without full factorial DoE.

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