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.

For lab research only, cannot be used for any clinical use.

Online Inquiry

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