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 ...

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 ...

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 ...

A new chapter is unfolding for gene therapies in Europe. With retinal programs advancing into Phase I/II trials and regulators introducing more flexible approval pathways for rare diseases, the field ...

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 ...

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 & ...

InDevR launches a new product that could shave weeks off the timeline to deliver flu vaccines in the event of a pandemic BOULDER (2/20/18) -- InDevR, a Boulder-based analytical technology and life ...