Depth filters composed of Cellulose and Diatomaceous Earth are widely used for cell culture clarification in biopharmaceutical industry. The cellulosic component of these filters are known to contain trace levels of β-(1-3) Glucan impurities which can potentially leach into product stream during processing. As leached β-(1-3) Glucan are considered process impurity, levels need to be maintained below defined threshold as per ICH Q6B guidance. β-Glucan leachable levels originating from different grades of depth filter media will be presented. A comparative performance of novel fully synthetic depth filter media with no Glucan leachables will be provided.

Assessment of beta glucan leachables originating from cellulose based depth filtration media

251st National Meeting (2016)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.