Release of first GMP drug substance for an Abzena inside product

The product is a novel therapeutic antibody being developed by clinical stage biotechnology company, Faron Pharmaceuticals

Abzena the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has completed the GMP drug substance manufacture of an Abzena inside product that was originally humanised utilising Abzena’s Composite Human Antibody platform.

The product is a novel therapeutic antibody, Clevegen, being developed by clinical stage biotechnology company, Faron Pharmaceuticals.

The manufacture of this product took place at Abzena’s site in San Diego, California but utilised significant bioanalytics and bioassay expertise from Abzena’s Cambridge, UK site including product characterisation, binding, potency and stability assays.

The bulk drug substance has now been released by Abzena for fill-finish with a third party.

Jim Mills, SVP Technical Operations of Abzena, said: “We are pleased to have enabled the progression of an Abzena inside antibody towards clinical development through this partnership."

"It really demonstrates the depth of our integrated services and technologies, showing how our sites work together to provide the support that our partners require to move their products forward from molecule design into clinical trials.”

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