• Strategic partnership provides a seamless one-stop-shop for biopharmaceutical development and manufacturing for large pharma, mid-size biotech’s and startup developers.
• The AGC Biologics & BioConnection collaboration offers new option for companies evaluating the potential impact of U.S. BIOSECURE Act.

AGC Biologics and BioConnection, a specialized contract manufacturing organization (CMO) focusing on aseptic filling of vials and syringes for clinical and commercial production, today announced a new strategic partnership. We are partnering 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 new partnership offers a seamless, full-service clinical-stage development and manufacturing solution that accelerates timelines and brings life-saving therapies to market more efficiently. By combining world-class drug substance and drug product services, AGC Biologics together with BioConnection now offer one convenient “gene to vial” value chain service with a single contract and project management team for the project lifecycle. Further, developers will save time and resources by avoiding long, complex processes associated with negotiating a separate drug substance and drug product contract and be able to conveniently plan drug filling activities for as soon as their substance release is scheduled – all through this new offering.

New Solution for Companies Potentially Impacted by U.S. BIOSECURE Act

This new 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 United States and Europe, developers now have a reliable and secure supply of services for development, manufacturing (including freeze-drying) and aseptic filling for their drug product’s needs.

AGC Biologics is especially well-positioned to support the needs of developers that may be impacted by this legislation, as it is one of the largest CDMO networks in the world offering single-use bioreactor technology. Developers seeking alternatives from their current outsourcing partner benefit from access to AGC Biologics’ single-use network utilizing ubiquitous bioreactor technology, enabling an easier transfer of platform processes and reduction in process changes associated with changing outsourcing partners.

Combined Expertise and Resources

Through this new joint offering, AGC Biologics and BioConnection are providing comprehensive solutions to meet the increasing demand for high-quality biopharmaceutical manufacturing services, while also continuing to offer their services independently.

AGC Biologics offers a broad range of protein-biologics services spanning from cell line development to commercial-scale manufacturing across its global network of facilities on three continents, supporting drug substances for microbial and mammalian-based systems, plasmid DNA (pDNA) and messenger RNA (mRNA). With a proven track record of delivering innovative biopharmaceutical solutions to clients worldwide, including supporting more than a dozen commercial products since 2018, AGC Biologics is renowned for its teams with deep technical and scientific expertise at its global facilities, and a commitment to quality, reliability, meeting product timelines and collaborating with developers to meet their needs.

BioConnection specializes in aseptic filling of vials and syringes, providing clients with tailored solutions for both clinical and commercial production of either liquid or freeze-dried products. Equipped with state-of-the-art facilities and a highly skilled team, BioConnection is dedicated to ensuring the highest standards of product quality and safety. Clients have valued BioConnection since 2005 for this and for its unmatched customer-oriented approach.

“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,” said Patricio Massera, CEO of AGC Biologics. “We believe BioConnection has a strong acumen, and this established partnership will enhance our biopharmaceutical manufacturing offering by providing drug product services for protein biologics, allowing us to create deeper relationships with developers to help get their products to patients in need.”

Similarly, Alexander Willemse, CEO of BioConnection, commented, “We are excited to join forces with AGC Biologics to offer integrated manufacturing solutions that address the complexities of biopharmaceutical development. Together, we are well-positioned to support our clients at every stage.”