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 ...
As gene therapies continue to advance, the demand for scalable, reproducible, and efficient potency assays is rapidly increasing—especially for adeno-associated virus (AAV) vectors. Accurate ...
Learn how viral vector release testing for AAV and lentiviral vectors utilizes orthogonal assays for titer, capsid content, ...
COLUMBUS, Ohio, May 04, 2026--(BUSINESS WIRE)--Armatus Bio, a late-preclinical stage biotech innovator developing vectorized RNAi medicines in neuromuscular disorders, today announced a new ...
Chimeric antigen receptor T-Cell (CAR-T) therapy has been approved by FDA to treat B-cell leukemias and has seen great clinical success. CAR-T cell manufacturing involves isolating T-cells from a ...
Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Executive Chairman, Longeveron · GlobeNewswire Inc. MIAMI, April 08, 2026 (GLOBE NEWSWIRE)-- Longeveron Inc. (NASDAQ: LGVN), a ...
Replacement of the in vivo rabies vaccine potency test (NIH test) by in vitro methods had been discussed by several researcher including WHO expert working groups. In this paper, a time-resolved ...
Rapid release of several successful vaccines against SARS-CoV-2 demonstrated that it was possible to release safe and efficacious vaccines based on in vitro assays with fast turn-around times.
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 ...
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 ...
The patent 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, ...
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 ...
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