Potency is a critical quality attribute of biological products, defined by the US FDA as the specific ability of the product to cause the required therapeutically clinical benefit. Potency assay will ...

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 ...

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 ...

insights from industryNatalie Strickland Global Head of Translational ScienceSynexa Life Sciences In this interview, News Medical speaks with Natalie Strickland, Global Head of Translational Science ...

GMP-compliant potency assay sample testing for clinical and commercial programs "Our clients have consistently valued the scientific depth and customer-centric approach our teams bring to their ...

EMERYVILLE, Calif.--(BUSINESS WIRE)--Slingshot Biosciences, the leader in precision-engineered cell mimic technologies, today announced the launch of TruCytes™ Potency, a new class of biomarker cell ...

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 & ...

Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, ...

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 ...

HOUSTON, Dec. 3, 2025 /PRNewswire/ -- Avance Biosciences today announced the opening of its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and ...