Abzena said that it has completed the GMP drug substance manufacture of an ABZENA Inside product that was originally humanized using the company’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, CA 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.
Abzena technical operations SVP Jim Mills 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.”
Abzena provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products.
The term ‘ABZENA Inside‘ is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies and ThioBridge Antibody Drug Conjugates (ADCs). Abzena has the potential to earn future licence fees, milestone payments and royalties on ABZENA Inside products.
Source: Company Press Release