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 ...

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

Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.

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 ...

Armatus Bio, a late-preclinical stage biotech innovator developing vectorized RNAi medicines in neuromuscular disorders, today announced a new publication in Molecular Therapy Advances summarizing the ...

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 ...

Intravacc offers state-of-the-art analytical methods for identity, content, purity, structure, formulation, stability, and preclinical ...

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.