Biologics, including cell & gene therapies, has been an active area of investment for pure-play biologics CDMOs, but it also has been a target for several CDMOs/CMOs of small-molecule APIs to position themselves or increase their offerings in the biologics space. A roundup of recent developments.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Key recent moves
Last month (September 2024), Hovione, a CDMO of drug substances and drug products, and iBET (Instituto de Biologia Experimental e Tecnológica), a private not-for-profit research institute, formed a new joint venture, ViSync Technologies, with the aim to develop technologies to support biopharmaceutical companies in the cell and gene therapy space. The joint venture combines Hovione’s expertise in pharmaceutical development, particle engineering, and industrialization of pharmaceutical technologies and iBET’s research in biotechnological sciences. One of the first focus areas of ViSync will be to develop technologies that improve delivery and stabilization of new modality therapies.

Also last month (September 2024), Eurofins CDMO Alphora, a Mississauga, Ontario, Canada-based CDMO of drug substances and drug products, announced plans to construct a new $64-million GMP biologics manufacturing facility in Mississauga, for producing monoclonal antibodies and protein therapies for clinical and commercial applications. Eurofins acquired Alphora Research, a CDMO of small-molecule active pharmaceutical ingredients (APIs) last December (December 2023).

The 50,000-square-foot biologics manufacturing facility, scheduled for completion in April 2026, will be housed within a new 112,000-square-foot building, constructed on Eurofins CDMO Alphora’s 14-acre campus in Mississauga. The facility will be equipped to the 2,000-L bioreactor scale, employ single-use technology, and be capable of running both fed-batch and perfusion modes. It will provide a fully integrated offering with a sterile fill line with a capacity of up to 24.9 million units annually. This investment follows the completion of Eurofins CDMO Alphora’s biologics development and pilot-scale facility, which has been operational since January 2024.

Earlier this year (2024), Olon, a CDMO of small-molecule and biologic drug substances, acquired GTP Bioways, a France-based CDMO of biologics. GTP Bioways provides R&D services, process development, and production of monoclonal antibodies, enzymes, proteins, nanodrugs, antibody drug conjugates (ADCs), and fill–finish services. GTP Bioways operates a total of four sites in France (Toulouse, Labège, Veyre-Monton, and Saint-Julien-en-Genevois) focused on development, clinical trial material supply, and cGMP manufacturing. The company’s headquarters are based in Toulouse.

Seqens, a CDMO of small-molecule active pharmaceutical ingredients (APIs), intermediates, and specialty ingredients, entered the cell- and gene-therapy space with its acquisition of CELLforCURE, a Les Ulis, France-based CDMO of cell and gene therapies, from Novartis, last December (December 2023). Novartis acquired CELLforCURE in February 2019 as part of its strategy to build its cell-and gene-therapy manufacturing network.

Also, in 2023 (May 2023), Siegfried, a CDMO of drug substances and drug products, acquired a 95% majority stake in Dinamiqs, a Swiss biotechnology company focused on the development and manufacturing of viral vectors for cell and gene therapies. Siegfried intends to bring Dinamiqs’ capabilities to commercial scale through the addition of a new manufacturing facility in Zurich-Schlieren, Switzerland, which is expected to come on line in 2025. Earlier this year (March 2024), Dinamiqs named Martin Kessler, formerly Chief Transformation Officer of Rentschler Biopharma SE, a CDMO of biologics, and previously CEO of Rentschler’s US biopharma business and operations, as its new CEO.

Recipharm, a Stockholm, Sweden headquartered CDMO of drug substances and drug products, has executed a multi-year strategic plan to add biologics capabilities as it exited the small-molecule active pharmaceutical ingredient space (API) space and evolved its position in drug products.  In 2022, it sold its small-molecule API manufacturing site in Cramlington, New Castle, UK API site, which it had acquired from Aesica Pharmaceuticals, to Pharmaron Beijing, a contract service provider, and entered the biologics market with several acquisitions: GenIbet, adding biologics drug substance capabilities; Vibalogics, which added cell- and gene-therapy services and Arranta Bio, which added live biotherapeutic products and RNA technologies. It then formed a new business unit focused on biologics, ReciBioPharm.

ReciBioPharm is partnered with the Massachusetts Institute of Technology (MIT) to advance continuous mRNA technology. In 2023, MIT received a three-year, $82-milion award from the US Food and Drug Administration (FDA) to develop a pilot-scale system for the first fully integrated, continuous mRNA manufacturing platform and formed the Center for Continuous mRNA Manufacturing.

On the drug product side, last month (September 2024), Recipharm completed the sale of seven sites to Blue Wolf Capital Partners, a US-based private equity firm. The sites included five sites in Sweden (Solna, Strängnäs, Höganäs, Karlskoga and Uppsala OTC Development); one site in France (Pessac); and one site in Spain (Parets). The divestment followed further restructuring of Recipharm’s operations, which included the sale of its Advanced Delivery Systems (ADS) business, Bespak, in early April 2024. Recipharm spun out Bespak to form a new stand-alone organization focused on drug-device combination products and drug-delivery devices for pulmonary and nasal inhalation. Reciopharm and Bespak are owned by the same private equity firm, EQT Private Equity.