Harvest clarification: User requirement specification (URS)

The BioPhorum Harvest Clarification team has created a user requirements specification (URS) for a harvest clarification solution that will handle ultra-high density mammalian cell cultures.

Cell separation technologies can be challenging. They are not robust or cost-effective enough to handle ultra-high density, cell culture batch harvests, especially in single-use processing.

“Upstream departments have made great strides in increasing productivity in CHO cells,” said Ashley Hesslein, Associate Director in Isolation & Purification, Biological Development at Bayer. “This has resulted in some processes where cell concentrations are significantly increased and the removal of cells becomes a bottleneck.”

To remedy this situation, new technologies must be created as manufacturing will increasingly demand larger facilities and more classified spaces, which will both impact on costs. Without change, harvest clarification will become a limiting step.

So how can our industry give supply partners the information they need to develop the technologies of the future?

The answer is through the BioPhorum Harvest Clarification team. This group of eight biomanufacturers and four supplier companies has created a user requirements specification (URS) for a harvest clarification solution that will handle ultra-high density mammalian cell cultures.

Hesslein added, “This working group came together in anticipation of the need to remove cells from cultures that are up to 30–50% solids as measured by packed cell volume; a challenge for all currently existing clarification technologies.”

This URS is the first collaboration of its type to come out of the BioPhorum Biomanufacturing Technology Roadmap program. Manufacturers often do this work in isolation and customize their technology, rather than working together to standardize it.

Charles Heise, Subject Matter Expert - Primary Separations and Filtration at FUJIFILM Diosynth Biotechnologies, said his organization had participated in defining the URS to “ensure future single-use harvest solutions will debottleneck primary separation and enable greater productivity from batch processing.”

Benefits

Using the URS to help explain biomanufacturers’ business needs to suppliers will help drive the innovation needed to stop harvest clarification from becoming a bottleneck. The business drivers of cost, speed, quality and flexibility will all be improved with the successful implementation of new solutions driven by the specification.

It will also increase performance and ease of use, while reducing containment risk, the footprint of cell harvest facilities and the pressure on utility needs and waste management.

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