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

A new Armatus publication summarizes a novel potency assay platform to advance gene silencing therapies for rare neuromuscular diseases.

Iovance Biotherapeutics has made progress in developing potency assays for lifileucel, a tumor-infiltrating lymphocyte therapy for advanced melanoma patients. Developing potency assays for lifileucel ...

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

Avance Biosciences opened its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and centralize the company’s capabilities in potency and functional ...

MarinBio publishes validated GMP/GLP cell-based potency assay for AAV-delivered anti-CD3-anti-CD19 diabody (GP101) in Journal of Immunological Methods. This publication is a milestone for the cell & ...

Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged developers of gene therapies to ...

OTC deficiency is a rare genetic condition and the most prevalent urea cycle disorder. Newborns with neonatal onset OTC deficiency exhibit hyperammonemia symptoms shortly after birth, including ...