Acumen Pharmaceuticals has selected Avid Bioservices to provide process development and clinical manufacturing services in support of ACU193, which is being developed for the treatment of Alzheimer’s disease.
ACU193 is a fully humanized IgG2 monoclonal antibody that selectively binds soluble Aβ oligomers, potentially blocking their toxic effects. Avid and Acumen will immediately commence process development work with the goal of creating a robust, cost-effective and scalable process to support cGMP manufacture of ACU193.
Process development and clinical manufacture of ACU193 will take place in facilities on Avid Bioservices’ CDMO campus in Orange County, CA. These include the company’s Myford facility, which is designed with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into this new facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics API manufacturing.
“This agreement with Acumen is the latest of what we expect will be several near-term client wins arising from our dedicated efforts to expand and diversify our customer base. The opportunity to work with Acumen and support the important work they are undertaking in the field of Alzheimer’s disease is gratifying for the entire Avid team,” said Roger Lias, president and chief executive officer of Avid Bioservices. “We look forward to delivering exceptional results to Acumen based on our proven ability to work efficiently and creatively to support the rapid advancement of novel therapeutics through process development and into cGMP clinical manufacturing.”