Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

Microbial assays are a technique to assess a compound’s potency or concentration. This is carried out by exposing microorganisms to the compound and determining its effect on them. Microbial assays ...