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BioReliance provides quality control testing on each production lot of a biopharmaceutical to ensure its safety, purity and potency, as specified by worldwide regulatory authorities, while meeting client production schedules and streamlining processes to guarantee on-time results. Testing applies to raw materials, unprocessed bulk, purified bulk and final-filled product. As specialists in the field, BioReliance covers the full spectrum of lot release testing including adventitious agents, identity, purity, potency, concentration, residuals and excipients, moisture and sterility.

State-of-the-art instrumentation is used within the laboratories to fully test biological products and final product sterility assays are performed using isolator technology so clients have absolute confidence in results. Biological and analytical lot release assays are compliant with GLP and cGMP regulations, and are stringently validated to meet worldwide regulatory guidelines.