Lot Release Testing

Lot release testing is essential to assess the purity, potency and identity of biological agents and is a critical part of ensuring drug quality and safety. Regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require a series of tests on unprocessed and purified bulk materials for each batch of biopharmaceutical production

Lot release testing is conducted at all stages of drug development:

• Raw Material
• Unprocessed Batch
• Purified Bulk (Drug Substance)
• Final Drug Product

Lot Release Testing Available

• Sterility - bacteria or fungal contaminants
• Identity - SDS-PAGE, Western blot, immunologic assay or amino acid analysis
• Purity - HPLC, SDS-PAGE, moisture, endotoxin
• Potency - In vivo or in vitro test to assess immunogenicity, antigen content or chemical composition

Why Choose Our Lot Release Testing Service?

• ✔ Our professional sample delivery process ensures seamless communication between our lab and our customers
• ✔ We provide test reports within one month and provide professional analysis on request.
• ✔ Our online data portal guarantees timely access to your test results
• ✔ Our experienced technical team can offer a single source solution for your needs.

Creative Biolabs offers a wide range of safety and quality testing services for a variety of biopharmaceutical products. All tests performed are fully validated and meet global regulatory requirements such as FDA, EMA and PMDA. Our experienced scientists can design a lot of release plans based on the characteristics of your biopharmaceutical products, or adapt an existing plan to meet your requirements.

Creative Biolabs provides our customers with a full range of service pipelines, from biosafety analysis to stability studies and to the determination of purity, identity and sterility of biopharmaceutical products. Our commitment is to provide one-stop contract services to all customers and to minimize product release time.

To find out more about our lot release testing services, please contact us.