The FDA-accredited facility will produce vials, pre-filled syringes, and expand to ADCs, GLP-1 drugs, and auto-injectors, strengthening biopharma capabilities in both U.S. and global markets.
- Sterile manufacturing capability in the US with over 100 million readily-available units (including vials and Pre-Filled Syringes – PFS)
- Extensions to include ADCs and auto-injector assembly
- Site accredited by FDA (CDER and CBER)
Recipharm, a leading contract development and manufacturing organisation (CDMO), and Exela Pharma Sciences, a US-based client-centric CDMO, are pleased to announce their exclusive strategic alliance aimed at enhancing sterile manufacturing capabilities in the United States.
This collaboration will provide Recipharm with access to Exela's state-of-the-art manufacturing facility located in Lenoir, North Carolina. The facility, accredited by the FDA (CDER and CBER), has a proven track record of delivering “light speed” projects during the COVID-19 pandemic. The site manufactures sterile injectable pharmaceuticals in vial and pre-filled syringe (PFS) formats.
Key highlights of the alliance:
- Available capacity for sterile products manufacturing (incl. PFS and vials): Exela’s facility enables Recipharm to expand its sterile manufacturing capacity in the US, offering the availability of over 100 million units 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.
- Fully automated manufacturing: Exela’s advanced manufacturing capabilities include Automatic Visual Inspection, automated packaging and auto-injector assembly, which positions the facility as the most suitable for producing GLP-1 drugs and other sterile products, such as vaccines and biologics.
- Regulatory standards and quality: The site which has been operating in compliance with US FDA standards for a number of years, will adopt international compliance practices consistent with Recipharm's stringent processes, operations and quality standards, to be able to serve ex-US markets for domestic and ex-US pharma and biotech customers.
- Analytical and ATMP capabilities: Recipharm will add to Exela’s capabilities by offering its robust analytical capabilities, commercial expertise and Manufacturing Science and Technology (MSAT) support. Additionally, ReciBioPharm, its biologics division, will contribute to the collaboration with its advanced therapeutic medicinal products (ATMP) capabilities.
- Proven rapid scaling: As demonstrated during the C19 pandemic’s Project Light Speed, Exela brings rapid and efficient tech transfers and scaling of production.
Greg Behar, CEO of Recipharm said: "We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the US. 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 world-wide reach. We are honoured and excited to be Recipharm’s exclusive US partner. This collaboration offers a unique and efficient CDMO platform for biopharma customers that seek to participate in both US and EU markets and are looking for scale, speed and versatility with experience in delivering complex projects,” stated Phanesh Koneru, Ph.D., LL.M., President & CEO of Exela.
