We provide cGMP-compliant lot release testing for raw materials, purified bulk (drug substance), and final filled product (drug product). With facilities on three continents, we mitigate risk and ensure supply chain continuity.
Protect your investment by trusting the purity and quality of the materials used in your biologic to us.
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Bulk Harvest Lot Release Testing
Whether you’re preparing for clinic or manufacturing a life-saving therapeutic biologic in multiple countries, protecting your investment with cGMP-compliant lot release testing is critical. We provide lot release testing solutions to meet the requirements of your biologic for preclinical and clinical studies, as well as licensed biologics.
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 biologics market with facilities in US, UK, and Singapore* – each compliant with global regulatory guidance, meaning you have only one partner to audit – we provide comprehensive lot-release testing solutions to support every stage of the biomanufacturing process. Through close collaboration and open dialog, we appropriately leverage our unrivalled biologics expertise to ensure the quality of your bulk harvest material meets regulatory requirements in any geography.
Our bulk harvest testing packages include:
- Sterility or bioburden
- Mycoplasma detection
- Adventitious virus and virology testing, including quantification of retrovirus-like particles
- Residual DNA
*Service offerings by facility are subject to change.