The facility will be adjacent to an existing site at Milford, Massachusetts, U.S., which Rentschler acquired from Shire in 2019. The latest expansion was launched in 2021, adding 22,000 square feet to the manufacturing cleanroom space with four 2,000-litre single-use bioreactors. It represents the biggest investment in the 150-year history of the company.
Onboarding clients
With the first engineering run of a batch of 2,000 litres already under its belt, the production line is already being used for a project with a client with others being onboarded. Late last year, Rentschler secured an undisclosed client for the new facility with the aim to manufacture a protein therapeutic for the treatment of cancer.
“As a fifth-generation, family-owned company, we stand at the forefront of manufacturing innovative therapies for patients with serious and rare diseases worldwide,” said Benedikt von Braunmühl, Rentschler CEO, in a public statement. “The completion of our new, state-of-the-art production line is an important milestone for our company and emphasizes Rentschler Biopharma’s strong capabilities in the U.S.”
Since the acquisition of the Milford site, Rentschler has taken it from a single-product commercial manufacturing center of 93,000 square feet to a 138,000 square-foot facility capable of handling multiple products.
Growing space
Rentschler has worked with more than 160 clients worldwide since 1997, with 60% staying on for more than five years, according to the company website. The firm also contributed to almost 25% of biopharmaceuticals approved by the US Food and Drug Administration in 2023.
CDMOs with expertise in the production of advanced therapy medicinal products (ATMPs) are in high demand due to the high complexity of therapies such as cell and gene therapies. The global market for CDMOs in advanced therapy medicinal products (ATMPs) was worth $6.1 billion in 2023 and is expected to hit £34.5 billion by 2033. This growth is driven by advances in technology in addition to rising demand for cell and gene therapies as the incidence of rare diseases grows around the world.
The CDMO space is also facing challenges as the US mulls the passing of the BIOSECURE Act, which aims to reduce the reliance of the biotech industry on providers in China including BGI, MGI, Complete Genomics and Wuxi Apptec. If it passes, the resulting demand gap would attract CDMO players in other geographies, including in the US, Europe and India.
“In light of evolving industry legislation, we remain committed to supporting our clients responsibly and contributing positively to both national interests and global health advancements,” stated Tom Roberts, President of Rentschler Biopharma Inc. and General Manager U.S.