mAbs Bulk Harvest Release Testing

Bulk harvest is the batch of materials taken from a bioreactor during the manufacture of a biologic. Typically comprising cells, spent media, the biologic, and any by-products of the reaction, this complex mixture requires rigorous testing to confirm the absence of any adventitious agents and ensure its suitability for downstream processing. Failure to identify contamination or investigate unexpected results at this early stage of the biomanufacturing process can lead to catastrophic downstream failure. 

Serving the worldwide mAb market with cGMP-compliant facilities in the U.S., U.K., and Singapore, our bulk harvest testing services investigate materials taken from bioreactors during the early stages of biomanufacturing to ensure that they are free of adventitious agents or unexpected results that can cause catastrophic failures in downstream processing.

We offer a comprehensive range of unprocessed bulk testing services, including:

• 14-days and 28-day in vitro virus assays
• 28-day mycoplasma
• qPCR for mycoplasma
• Mouse Minute Virus (MMV) qPCR
• MMV in vitro
• Sterility by membrane filtration
• Sterility by direct inoculation (14-day sterility)
• Residual CHO DNA
• Bioburden

Through close collaboration and open dialog, our talented advisors can offer you global regulatory guidance and unrivalled biologics expertise with only a single partner to audit – ensuring that the quality of your bulk harvest material meets regulatory requirements in any geography. If your molecule requires a specific complex project, we can respond with a group of PhD scientists offering deep content expertise for troubleshooting and guidance.*

*Service offerings by facility are subject to change.

Related Product Resources

• Flyer: Comprehensive Lot Release Testing

  We offer a comprehensive range of services and assays aimed at ensuring the quality and purity of unprocessed and purified bulk harvest materials used in the production of biologics for the biopharmaceutical industry.

• White Paper: Accelerating Bulk Harvest Testing using the Blazar^® CHO Animal Origin Free Virus Panel for Rapid Adventitious Virus Detection

  This white paper describes the Blazar^® CHO Animal Origin Free (AOF) panel for rapid adventitious virus detection, a degenerate PCR-based approach to broad virus screening.

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Related Webinars

Current Regulatory Expectations and Technical Advances in the Quality Control of Biological Medicinal Products

This webinar describes topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments will be discussed.