Lot Release Testing

Perhaps the most critical of tests, lot release testing is the final requirement before reaching the patient population. Speed and reliability in a partner is crucial for a robust global supply chain. Our analytical assays are performed to GMP guidelines to evaluate the purity, potency, and identity of biologics as required by regulations.

Testing is performed at all stages of drug development:

• Raw Materials
• Unprocessed Bulk
• Purified Bulk (Drug Substance)
• Final Product (Drug Product)

Lot release testing relies on previously established specifications to demonstrate product identity, purity, and potency. With fast turnaround times and qualified scientists working with you to develop a customized lot release program, we are committed to helping you get a quality product to market sooner.