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.

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.

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

Designing in Quality: Approaches to Defining the Design Space for a Monoclonal Antibody Process

May 1, 2010

How to use risk assessment strategies to integrate operations.

Pandemic Response: Progress and Challenges

May 1, 2010

We all know that experience is the best teacher. With H1N1, we have a great opportunity to learn important lessons.

Developing a MAb Aggregate Removal Step by High Throughput Process Development

April 1, 2010

HTPD allows rapid screening of chromatographic parameters.

A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass Vials

April 1, 2010

A systematic approach facilitates formulation component selection.

The Challenge of Defining the Higher Order Structure of Biopharmaceutical Products

March 5, 2010

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

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