Image Credit: Business Wire, Catalent
Catalent, a contract development and manufacturing organization (CDMO), has completed expansion of its clinical supply plant in Schorndorf, Germany.1 The Schorndorf site—which offers clinical supply services, such as packaging, storage and distribution— is considered the CDMO’s flagship European facility and has been in operation since 1996.
The development project grows the Schorndorf location by 32,000 square feet, which will help handle the extra storage and additional handling of clinical trial supply materials at controlled room temperatures (between 15°C and 25 °C).
As a result, the original building is now able to have capacity for a new, fully automatic bottle filling line, along with a section for the company’s branded supply service, FastChain, a good manufacturing practices (GMP) approach that separates primary from secondary packaging in order to allow for cost-effective adaptation supply of clinical materials.
Catalent is anticipating that these new offerings will directly patients first and foremost, followed by the biotech and pharma customers.
“The Schorndorf site plays an important role in the strategic focus of the company and our ability to meet customer demand for clinical packaging solutions, including temperature-controlled services,” said Lorenzo Carletti, president, clinical development & supply, Catalent. “We are pleased to bring additional capacity to the site for temperature-controlled storage and Catalent’s FastChain service so that we can meet the current and future needs of our customers.”
In other Catalent news, the CDMO recently entered into a strategic partnership that would assist with the development and manufacturing of Siren Biotechnology’s adeno-associated viral (AAV) immuno-gene therapies.2 Catalent would be providing process optimization at its process and clinical development center in Baltimore, MD.
“We look forward to working with Catalent, a leading CDMO with premier capabilities in AAV vector development and manufacturing, on the development of our AAV Immuno-Gene Therapies,” noted Dr. Nicole Paulk, founder, CEO, and President of Siren Biotechnology. “This partnership demonstrates our commitment to a robust manufacturing process that will move our therapeutic programs into the clinic as quickly as possible.”
David McErlane, Catalent’s group president of biologics, added that, “Catalent is committed to partnering early in the development process with innovative companies like Siren. We are excited to work together to pioneer a pathway for the development and commercial manufacturing of safe, high-quality AAV gene therapies to provide life-saving treatments to patients with cancer.”
Back in February, Catalent was acquired by Novo Holdings in an all-cash deal that values Catalent at $16.5 billion on an enterprise value basis.3
“This transaction delivers significant, certain and premium value to our stockholders,” commented John Greisch, executive chair of the Catalent board and chair of the Strategic and Operational Review Committee, at the time of the deal. “Novo Holdings believes in our vision and will provide Catalent with a strong foundation as we continue developing, manufacturing and supplying top products.”
References
1. Catalent Completes $25 Million Expansion of its Clinical Supply Facility in Schorndorf, Germany. Business Wire. July 16, 2024. Accessed July 16, 2024. https://www.businesswire.com/news/home/20240716141571/en
2. Partner Release: Siren Biotechnology and Catalent Enter Partnership for Manufacturing of AAV Gene Therapies for Cancer. Catalent. May 8, 2024. Accessed July 16, 2024. https://www.catalent.com/catalent-news/siren-biotechnology-and-catalent-enter-partnership-for-manufacturing-of-aav-gene-therapies-for-cancer/
3. Novo Holdings to Acquire Catalent. Catalent. February 5, 2024. Accessed July 16, 2024. https://www.catalent.com/catalent-news/novo-holdings-to-acquire-catalent/