AGC Biologics, a CDMO, and BioConnection, a CMO, agreed to partner to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug product using the development and manufacturing expertise of AGC Biologics and the specialized aseptic filling capabilities of BioConnection.
The companies offer a “gene to vial” value chain service with a single contract and project management team for the project lifecycle, according to Patricio Massera, CEO of AGC Biologics, who noted that this strategic partnership addresses the ongoing needs of the industry in the wake of the proposed U.S. BIOSECURE Act. By having a combined end-to-end solution that uses facilities in Japan, the U.S., and Europe, developers now have a secure supply of services for development, manufacturing, (including freeze-drying) and aseptic filling for their drug product’s needs, he said.
The BIOSECURE Act would prohibit executive agencies from contracting with any entity where the biotechnology equipment or services of a “biotechnology company of concern” would be used in the performance of that contract. Generally speaking, according to the law firm Ropes & Gray, a “biotechnology company of concern” is one that is “headquartered in or subject to the jurisdiction of a foreign adversary’s government and poses a threat to national security.” Among the companies named in the bill are WuXi Apptec, WuXi Biologics, MGI, BGI, and Complete Genomics.
The U.S. House Oversite Committee voted 40-1 on May 15 to send the Act to the full House for a vote.
“Now more than ever global pharmaceutical companies and developers need reliable facilities to produce and fill their drug products, and by combining our resources with BioConnection we are offering a new end-to-end solution for them under one contract with AGC Biologics,” continued Massera.
“We are excited to join forces with AGC Biologics to offer integrated manufacturing solutions that address the complexities of biopharmaceutical development,” added Alexander Willemse, PhD, CEO of BioConnection.
