Announced in 2021, the facility has four 2,000 L single-use bioreactors and is the contract development and manufacturing organization’s (CDMO’s) largest investment historically. This expansion brings the total production lines at the site to three and focuses on highly complex molecules including monoclonal antibodies (mAbs), multispecific antibodies, recombinant enzymes, and other therapeutic proteins, crucial for treating serious and rare diseases.
“Transitioning to a multi-product facility significantly enhances our flexibility and capacity to serve our clients,” a spokesperson for Rentschler told BioProcess Insider.
“Previously, the Milford site was a single-product commercial facility, but now it can simultaneously handle multiple projects and products. This allows us to better meet the diverse needs of our clients and accommodate a broader range of biopharmaceuticals, enhancing our overall service offering and market responsiveness.”
According to the firm, single-use bioreactors allow a single-use process flow for product-contacting materials from vial thaw through to drug substance production, improving efficiency, saving time and virtually eliminating the risk of cross-contamination.
Additionally, “the facility integrates both single-use and traditional stainless steel buffer mixers, enhancing plant efficiency and throughput,” the spokesperson said.
“To ensure the reliability and quality of our products, we have implemented a rigorous quality management system that includes continuous monitoring, comprehensive testing, and strict adherence to cGMP standards. Our cleanroom space is equipped with environmental control systems, and our single-use bioreactors are designed to minimize contamination risks. Additionally, our highly trained staff conducts regular audits and validation procedures to maintain the highest standards of product quality and safety.”
In September 2023, the family-owned firm opened its Stevenage, UK facility to clinically produce adeno-associated virus (AAV) vectors for gene therapies. The site received the cGMP Manufacturing Compliance Certificate from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
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