Preparing for the pivot to downstream continuous processing

By Nick Taylor

- Last updated on GMT

Pic:getty/salcle
Pic:getty/salcle

Related tags: Continuous bioprocessing, Repligen

Upstream processes were the focus of most early applications of continuous bioprocessing. That is now changing, with many biologic manufacturers evaluating downstream continuous processing and suppliers preparing their portfolios for the anticipated pivot toward the approach.

The first companies to move away from batch processing typically adopted continuous bioprocessing technologies such as perfusion for upstream processes but still used conventional purification for the downstream steps. Keeping production cells in the bioreactor for a month or more is associated with lower costs and increased productivity, although even in that upstream setting continuous processes remain the exception.

Biomanufacturers were using perfusion to make commercial products while developers of simulated moving bed systems and other continuous chromatography technologies were still working toward readiness for commercial-scale use. There remains work to do on such downstream applications of the continuous model but there are signs the industry is moving in that direction.

A 2020 survey of bioprocessing professionals by BioPlan Associates found 38% of biomanufacturers and 53% of contract manufacturing organisations (CMOs) planned to assess downstream continuous purification in the next year. That compares to the 46% biomanufacturers and 33% of CMOs that planned to evaluate upstream continuous processing in the coming 12 months.   

The finding suggests continuous downstream processes are being evaluated roughly as frequently as upstream continuous processes. Use of continuous processing in either context remains rare and the situation is changing slowly, but suppliers are already making plans to serve the market.

In late October, Repligen disclosed deals to buy ARTeSYN for $200m and Non-Metallic Solutions (NMS) for a smaller, undisclosed sum. News of the two takeovers came shortly after Repligen bought Engineered Molding Technology.

The deals gave Repligen ownership of single-use bioprocessing systems and flow paths and vertically integrated supply of certain products. John Kreger, an analyst at William Blair, said the acquisitions should “improve the company’s supply chain control​,” leading to “shorter production wait times​.”

Repligen talked up the near-term benefits of expanding its flow path and single-use systems portfolio but also framed the acquisitions as part of a longer-term strategy to get ready for greater use of continuous downstream bioprocessing.

These acquisitions in the longer term also position us well as our industry pivots to downstream continuous manufacturing​,” said Repligen CEO Tony Hunt.

How long the pivot will take remains to be seen. Barriers to the widespread adoption of continuous downstream bioprocesses on commercial scales remain. Even so, the direction of travel is becoming clearer.

Related topics: Downstream Processing

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