Bulk Lot Release Testing
Every lot of product produced, both for preclinical and clinical studies requires a series of tests on both unprocessed and purified bulk harvest material which should be separate from final container 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 biologicals for the pharmaceutical and biotech industries.
Our bulk harvest lot release testing services are cGMP compliant and are in compliance with quality assurance and regulatory guidelines.
The following services are recommended for bulk harvest lot release testing;
- Sterility Testing
- Mycoplasma Detection Assays
- Adventitious Virus Testing / Virology Testing
- Mouse Antibody Production Tests
- Transmission Electron Microscopy Services
- Residual DNA
- Endotoxin Detection, LAL Test
Contact an expert about your needs and for any custom bulk harvest lot release testing.
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