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mAbs Final Product Release Testing

GMP biosafety testing for mAb product release

Every lot of monoclonal antibodies produced for preclinical and clinical studies requires a series of tests to ensure that active ingredients are free of contaminants according to 21 CFR 211.165 and 21 CFR 610. Our comprehensive spectrum of cGMP-compliant final product testing services provides assurance of patient safety and regulatory compliance in any geography, with service provision on three continents and backup facilities to ensure continuity of supply.

You can rely on our knowledge, capabilities, and vision with complete confidence at any stage of the biomanufacturing process. Our recommended final product release testing services include:

  • Sterility by membrane filtration
  • Sterility by direct inoculation (14 day Sterility)
  • Endotoxin (LAL)
  • Characteristics of the final product

To discuss your final product release testing needs, use our reply form and get in touch today.

Related Product Literature

Flyer: Comprehensive Lot Release Testing

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Related Applications
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing requires scalable solutions ensuring high therapeutic concentration and process safety for immunotherapy.
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Viral Clearance studies are critical to the validation of downstream processes, ensuring viral clearance process steps are effective and reproducible in the biopharma manufacturing setting.
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.
mAb Product Characterization
When moving your monoclonal antibody (mAb) from concept to clinic, our product characterization services and assay packages help ensure your biotherapy’s safety, purity, and potency while expediting quality decisions at every stage.
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