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.

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.

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.

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).

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.

Meningitis Vaccine Purification: Quality Control of Ultrafiltration Membrane Porosity

August 1, 2010

How to balance porosity, plugging, and lot-to-lot variability in filters.

Downstream Disposables: The Missing Link in the Disposables Chain

August 1, 2010

Although single-use systems are widely used in upstream unit operations, their acceptance in downstream processes has been slow.

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