Recipharm and Exela Pharma Sciences entered into an exclusive strategic alliance aimed at enhancing their combined CDMO sterile manufacturing capabilities in the United States. This collaboration will provide Recipharm access to Exela’s manufacturing facility in Lenoir, NC, which has been accredited by the FDA (CDER and CBER). The site manufactures sterile injectable pharmaceuticals in vial and pre-filled syringe (PFS) formats.
According to Greg Behar, CEO of Recipharm, which is headquartered in Stockholm, Exela’s facility enables Recipharm to expand its sterile manufacturing capacity in the United States, offering the availability of over 100 million units of production capacity for customers. The site is extending into producing highly targeted biopharmaceutical drugs, such as antibody drug conjugates (ADCs), GLP-1 drugs, and other sterile products, such as vaccines and biologics.
Exela’s manufacturing capabilities
Exela’s manufacturing capabilities include automatic visual inspection and automated packaging and auto-injector assembly. The site, which has been operating in compliance with FDA standards for a number of years, will adopt international compliance practices consistent with Recipharm’s operations and quality standards, to be able to serve ex-U.S. markets for domestic and ex-U.S. pharma and biotech customers.
Recipharm plans to add to Exela’s capabilities by offering its analytical capabilities, commercial expertise, and manufacturing science and technology (MSAT) support. Additionally, ReciBioPharm, the company’s biologics division, will contribute to the collaboration with its therapeutic medicinal products (ATMP) capabilities.
“We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the United States,” noted Behar. “This partnership aligns with our commitment to provide high-quality manufacturing solutions and expand our capabilities in the production of sterile products, such as GLP1, peptides, biologics, ADCs, and other critical pharmaceuticals.”
“Recipharm is a highly respected CDMO with worldwide reach. This collaboration offers a unique and efficient CDMO platform for biopharma customers that seek to participate in both U.S. and EU markets and are looking for scale, speed, and versatility with experience in delivering complex projects,” added Phanesh Koneru, PhD, president and CEO of Exela.
