Overview:
Potency Testing is a critical analytical procedure used to quantify the biological activity of a pharmaceutical product. This ensures that each batch delivers the intended therapeutic effect, making it an essential part of quality control and regulatory compliance for biologics, vaccines, biosimilars, and active pharmaceutical ingredients (APIs).

Test Description:
Potency tests evaluate a drug’s ability to produce a specific biological response by comparing its activity against a known reference standard. These tests can be in vitro (e.g., cell-based assays) or in vivo (animal studies), depending on the nature of the product and regulatory requirements.

Purpose & Benefits:

• Confirm that drug products deliver the intended therapeutic response
• Verify batch-to-batch consistency and bioequivalence
• Required for regulatory submissions, stability studies, and product release
• Detect any degradation or loss of potency over shelf-life

Industries Served:

• Biopharmaceutical & Biotechnology Companies
• Vaccine Manufacturers
• Biosimilars & Monoclonal Antibody Producers
• Hormonal & Enzyme Therapeutics