Acticor Biotech selects Catalent GPEx Cell Line Development Technology to develop ACT-017
Acticor Biotech is developing an antibody fragment (Fab) considered as a first-in-class anti-thrombotic agent without bleeding risk in the primary treatment of ischemic strokes.
Acticor Biotech has selected Catalent’s proprietary GPEx technology for the development of its Fab candidate, ACT-017, targeting the platelet glycoprotein VI (GPVI).
The GPEx platform creates stable, high-yielding mammalian cell lines with high speed and efficiency and the advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and 34 therapeutic candidates are currently undergoing clinical trials across the world.
Catalent’s high-performance expression platform was chosen following a thorough evaluation, whereby the use of GPEx for the manufacture of ACT-017 was benchmarked against another proprietary mammalian cell line technology, an E. coli bacterial platform, and a Pichia pastoris yeast expression system.
Using GPEx technology enabled the optimised production of ACT-017, which displayed excellent functionality evaluated upon collagen induced platelet aggregation inhibition, as well as a productivity level aligned with the manufacturing scales required for further clinical and commercial development stages.
“We are extremely pleased to have passed this critical milestone for the development of our Fab candidate and have selected a cell line development technology which is recognized by the Regulatory Authorities and has enabled clinical and commercial developments of a number of biologic products,” commented Dr Gilles Avenard, CEO of Acticor Biotech.
“GPEx technology was designed to offer clients and partners advantages over conventional cell line engineering systems, including increased flexibility and higher, more stable yields,” commented Mike Riley, Vice President and General Manager of Catalent Biologics. “We are pleased to be able to partner with Acticor Biotech to bring this important new therapeutic to market.”
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