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.

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.

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.

PEG Precipitation: A Powerful Tool for Monoclonal Antibody Purification

March 2, 2010

This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.

Advances in Monoclonal Antibody Purification

March 2, 2010

New technologies and adaptations of existing technologies can improve platform processes.

The Time Value of Information in Designing Downstream Purification Processes

March 2, 2010

To speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how.

Mixed-Mode Chromatography in Downstream Process Development

March 2, 2010

Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.

Downstream Processing: Promising Technologies are on the Horizon

March 1, 2010

The new technologies being developed to improve downstream systems go beyond traditional chromatography.

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