Biomanufacturing

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Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

This revised extractables protocol for polymeric single-use components in biopharmaceutical manufacturing is based on an extensive scientific review and represents the combined opinion of the biopharmaceutical manufacturers and, crucially, the supply chain. It will reduce costs and focus people on the important data points. The protocol provides guidance on the suggested methods for extractables studies, including sample preparation, extraction conditions, recording test-article sampling conditions, and reporting data from the analysis of extracts. Flexibility is built-in, allowing suppliers to alter many study parameters due to restrictions based on the use of SUS, physical form factor, chemical compatibilities, etc.

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts.

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Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by: producing products with a more consistent quality attribute profile allowing greater flexibility to react to changes in market demands reducing up-front capital investment in facilities optimizing the cost of goods. However, despite these potential benefits,...

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