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Viral Contamination in Biological Manufacturing

October 2009

A major concern for many biologics is viral contamination. The ICH Q5A regulatory guideline indicates that a manufacturer of biological products for human use should demonstrate the capability of the manufacturing process to remove or inactivate known contaminants.

 

Bioreliance's new Genesis Freeze Dryer

One aspect of assessing the viral safety of a biopharmaceutical is to perform a viral clearance study. In order to assess the level of risk the removal/inactivating steps that are potentially the most effective are challenged with known or potential viruses which may be present in the product in question.

BioReliance provides testing and manufacturing services to pharmaceutical and biopharmaceutical companies that span the product cycle from early pre-clinical development to licensed production. Their goal is to advance the development and delivery of healthcare and consumer products by providing the highest quality testing, development and manufacturing services in partnership with clients worldwide. BioReliance is the largest provider of safety testing services focused on the rapidly growing biologics sector of the pharmaceutical and biotechnology industries.

To support such studies BioReliance purchased a new VirTis Genesis freeze drier earlier this year. This “state of the art freeze drier” has provided BioReliance with the flexibility to meet all their client’s demands in terms of their freeze drying steps.

Roslyn Cameron, Laboratory Director Process Operations says “our experience of BioPharma has been a very positive one. BioPharma provided a high level of support and understanding in BioReliance’s service requirements and worked in collaboration with BioReliance personnel to configure a custom built machine to fit the needs of our business. Our team were trained and fully supported in the installation of the freeze drier by BioPharma personnel who have provided a first class service which met our needs to a very tight timeframe.”

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More information about Genesis freeze dryer
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