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 of microbial contamination is inherent in most production scenarios for biologicals. Conditions in the upstream process, with controlled temperature and a nutrient-rich medium, support not only growth of the target cells, but also of other biological organisms.
Downstream operations also have their share of challenges. Open containers can be used to transfer product or handle buffers. Raw materials and processing aids that have contact with the product, such as chromatography resins and buffer components, are introduced. The transfer of equipment between rooms exposes a process to contamination. Unit operations such as chromatography frequently involve a large amount of manual handling, for example, during resin slurry preparation and column packing. Success is highly dependent on the skill and experience of personnel; and wherever humans intervene, there is a potential source of bioburden.
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