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

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 ...

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 ...

Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVID-19.

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 ...

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 ...

Mesoblast has taken another step on the path toward its third attempt to win approval of its off-the-shelf therapy, exiting a meeting with the FDA convinced that new potency assay data and a ...

Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Executive Chairman, Longeveron Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived ...

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 ...

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, ...