Sat. Jun 15th, 2024

–News Direct–

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), 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. The companies 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 products 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 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."

For more information about AGC Biologics please visit www.agcbio.com. Visit www.bioconnection.eu to learn more about BioConnection.

About BioConnection:

BioConnection is a specialized contract manufacturing organization (CMO) focusing on aseptic filling and lyophilization of vials and syringes for clinical and commercial production. With state-of-the-art facilities, a proven successful EMA and FDA track record and a team of experienced professionals in Oss, The Netherlands, BioConnection provides tailored solutions to meet the unique needs of clients in the biopharmaceutical industry. BioConnection is specialized in fill & finish and lyophilization of small and large molecules, orphan drugs, personalized medicine and controlled substances. Its customers value BioConnection for its reliability. BioConnection is renowned for its reliability, with customers appreciating the certainty of delivery made possible by its extensive capacity. The company combines this reliability with a personalized approach to client relations. Discover more at www.bioconnection.eu.

About AGC Biologics:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

Contact Details

AGC Biologics

Nick McDonald

+1 425-419-3555

nmcdonald@agcbio.com

BioConnection

Dennis Link

+31 412 846 036

Company Website

https://www.agcbio.com/

View source version on newsdirect.com: https://newsdirect.com/news/agc-biologics-and-bioconnection-partner-to-offer-new-end-to-end-biopharmaceutical-drug-substance-and-drug-product-development-and-manufacturing-offering-961424576

AGC Biologics

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