Sartorius and Waters expand partnership with eye on continuous production

Sartorius will leverage its process scale multi-column chromatography with Waters’ process analytical technology to provide analytical data for downstream biomanufacturing.

In October 2021, bioprocess vendor Sartorius struck a partnership with Waters to use its BioAccord Liquid Chromatography (LC)–MS System as a new bioprocess analyzer for its Ambr multi-parallel bioreactor systems in an effort to accelerate speed and increase accuracy in bioprocessing analysis.

18 months on and the partnership has expanded, with the new integrated mix aiming to deliver analytical data in days, helping to reduce waste and help lower drug production costs.

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“Implementation of near real-time PAT (process analytical technologies) during the purification of recombinant protein biotherapeutics will give process developers and manufacturing engineers the opportunity to take critical and timely decisions to continuously control the process within the design space, resulting in more consistent drug substance quality and significant cost savings on out of spec product waste by early indication of quality deviations,” a spokesperson from Waters told this publication.

“This is particularly important to support the trend towards the adoption of continuous processing, as opposed to batch processing. Analytics that provide rapid, directly actionable, and integrated measurements for downstream process teams can be used for more advanced process control, deviation management, and ultimately real-time release of batches.”

Specifically, Waters PATROL UPLC Process Analysis System will be integrated with Sartorius’ Resolute BioSMB system, allowing continuous monitoring of critical quality attributes (CQAs) like aggregation and charge variant profiles in product streams.

“Ultimately, this contributes to raise the quality standards of life-saving therapeutics, allows for their greater accessibility to people in need, globally, and can potentially alleviate the shortages we’re now seeing with some brand name and generic drug products.”

When asked whether there would be further collaborations between the two firms, we were told: “Waters and Sartorius are committed to providing biologics manufacturers with the best tools to ensure efficient manufacturing of safe and effective drug products through the development of integrated production and analytical systems, and partnerships with our customers. Our collaboration will continue with those objectives in mind.”