Slingshot Biosciences, the leader in precision-engineered cell mimic technologies, today announced the launch of TruCytes™ Potency, a new class of biomarker cell mimics specifically designed for ...
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 ...
Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...
The CellTiter-Glo® Luminescent Cell Viability Assay uses luminescence to accurately determine the number of viable cells in a culture. Sequentially process plates exhibiting a highly consistent ...
Since the FDA first approved CAR-T cell therapy in 2017, eight CAR-T drugs have emerged, six of which have been fully approved by the FDA. This groundbreaking cell therapy has brought about a series ...
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 ...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors, ...
BOSTON, MA—A small study has shown some promising signals with cell therapy using bone marrow mononuclear cells for the treatment of patients with heart failure with reduced ejection fraction (HFrEF).
Mesoblast isn’t giving up on its allogeneic cell therapy remestemcel-L. In September 2020, the FDA took the unusual step of going against its independent expert reviewers and knocked back the ...