Articles by James E. Seely, Ph.D. - BioPharm International

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Articles by James E. Seely, Ph.D.

Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration

Constraints associated with equipment can make scale-down a challenging exercise.
Apr 1, 2005

Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.

Making Site-specific PEGylation Work

Purification and analysis of PEGylated protein pharmaceuticals presents many challenges.
Mar 1, 2005

There are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.

A Rational, Step-Wise Approach to Process Characterization

Aug 1, 2003

Process characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.

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