AGC Biologics Partners with BioConnection to Offer Biopharma Drug Substance and Drug Product Development and Manufacturing

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Editor's note: this story was originally published on BioPharmInternational.com.

AGC Biologics announced on May 22, 2024 that is has formed a new strategic partnership with BioConnection, a contract manufacturing organization specializing in aseptic filling of vials and syringes for clinical and commercial production. The companies plan to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug product.

The goal of this partnership is to offer full-service clinical-stage development and manufacturing to shorten timelines and bring biopharmaceuticals to market more efficiently, a “gene to vial” value chain service that comprises a single contract and project management team for the project lifecycle, according to a company press release. The partnership addresses the industry’s ongoing needs in light of the proposed US BIOSECURE Act proposed by US legislators in January 2024, which states, “Specifically, the bill prohibits executive agencies from 1) procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern, or 2) entering into a contract or extending or renewing a contract that uses such equipment or service or that will require the direct use of such equipment or services. Those agencies may not obligate or expend loan or grant funds for such purposes” (1).

“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,” stated Biogen in its press release.

According to the release, AGC Biologics is well-positioned to support drug developers’ needs, especially those who may be impacted by the proposed legislation. “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,” the company stated in the press release.

AGC Biologics protein-biologics services comprise cell line development through to commercial-scale manufacturing, and the company’s capabilities support drug substance manufacturing from microbial- and mammalian-based systems as well as plasmid DNA and messenger RNA. BioConnection’s aseptic filling capabilities for vials and syringes offer tailored solutions for clinical and commercial production of either liquid or freeze-dried products.

“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, in the press release. “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.”

Alexander Willemse, CEO of BioConnection, added in the release, "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."

Reference

1. US Congress. H.R.7085 - BIOSECURE Act. ww.congress.gov (accessed May 23, 2024).

Source: AGC Biologics