A good bioassay, like a good marriage, joins two partners in a bond and is mutually beneficial. In the case of bioassays, optimal design and development and accurate statistical analysis comprise a ...

Developing and validating appropriate biological assays can spell success or failure for biopharmaceutical products. Whether using live systems or biologically derived reagents, scientists must ...

As the development of increasingly complex biologics grows, more robust bioassays are required to accurately characterize these molecules. Bioassays play a crucial role in biologic drug development as ...

The 2nd Gene Therapy Potency Summit is returning to Boston in July to support you in designing and validating robust potency assays to accelerate commercialization across a range of vector types and ...

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

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

A biochemical test used to determine the strength or potency of an object by its effect on a living organism, tissue, or cell. Bioassay is a testing procedure used in biopharmaceutical products to ...

USP promotes horizontal standards for biologics' quality attributes. In a study released in May 2011, US regulatory approvals for biologic drugs and biotechnology products (collectively referred to as ...