Author Archives: David Westman

Bioburden: Current Innovations and Practices to Address Microbial Contamination in Downstream Bioprocessing

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Bioburden control is an area of serious concern for both manufacturers of biologicals and suppliers to the industry. This white paper considers some of the risks related to downstream processing and presents recent developments by suppliers that help manufacturers mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working. Challenges specifically related to the sanitization of protein A chromatography resins also are discussed. Bioburden Control in Biopharmaceutical Production The risk…

August 10, 2017

Collaborating to Address the Bioburden Challenge

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Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies and their suppliers must collaborate. To meet this challenge, GE Healthcare is committed to continuous improvement of its chromatography resins to enable delivery of products without detectable bioburden. For example, development of Protein A resins to withstand high NaOH concentrations…

August 9, 2017
Tsunami - Japan 2011

Supply Chain Challenges in the Biopharmaceutical Industry: A Case Study Following the 2011 Tsunami in Japan

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Global manufacturing of biopharmaceuticals for human use helps save the lives of millions of people and is a large commitment to public health. The industry operates in an environment with financial uncertainties and complex international supply chains, so the question of risk mitigation is paramount. There is an expectation that comprehensive risk mitigation programs should be in place to minimize the risk of supply chain interruptions that would negatively affect the manufacture of these vital therapeutics. Here we share how…

September 11, 2014