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.

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.

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.

Technical and Economic Benefits of Membrane Chromatography During Polishing Steps

August 1, 2010

An analysis of flow rate, load density, viral clearance, and cost.

Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part 2

July 1, 2010

Will Protein A Be the Long-Term Solution for Your Purification Needs?

June 1, 2010

Biomanufacturers and vendors are now exploring more cost-effective purification technologies.

Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part I

June 1, 2010

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