Articles by Susan Powers, PhD - BioPharm International

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Articles by Susan Powers, PhD

A Rational Approach for Setting & Maintaining Specs for Biological & Biotechnology–Derived Products—Part 3

The Biologics and Biotechnology Working Group on specifications of the Pharmaceutical Research and Manufacturers of America presents new approaches to analyzing development and manufacturing data.
Aug 1, 2008

Set limits to provide incentives for process improvements.

A Rational Approach for Setting and Maintaining Specs for Biological & Biotechnology–Derived Products—Part 2

The Biologics and Biotechnology Working Group on specifications of the Pharmaceutical Research and Manufacturers of America presents new approaches to analyzing development and manufacturing data.
Jul 1, 2008

Resolve confusion about measurements.

A Rational Approach for Setting and Maintaining Specs for Biological and Biotech–Derived Products—Part 1

Currently, there is no industry-wide guideline about the process for establishing specifications for biologicals at different stages of the product lifecycle. The Working Group on Specifications and Formulations of the PhRMA Biologics and Biotechnology Leadership Committee set out to help fill this gap. The first of a three-part article.
Jun 1, 2008

A staged approach to limits should embrace future capabilities.

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