Recipharm and Exela collaborate to boost US sterile injectable production

With the collaboration, Swedish CDMO Recipharm has gained access to Exela’s Lenoir, North Carolina facility, which is accredited by the US Food and Drug Administration (FDA). The facility manufactures sterile injectable pharmaceuticals in vial and pre-filled syringe (PFS) formats.

The CDMOs have leveraged their combined expertise to successfully launch several products, including emerging therapeutics such as Glucagon-like peptide-1 (GLP-1) drugs and vaccines.

“Exela brings US-based sterile manufacturing expertise, while Recipharm enhances Exela’s offerings with its robust analytical, commercial and manufacturing expertise in global regulatory standards and quality control,” a spokesperson for the Recipharm told BioProcess Insider.

“This collaboration aligns with Recipharm’s long-term goals of expanding its US presence and enhancing service capabilities. Following the site’s expansion, the partnership will include capabilities such as auto-injector assembly and antibody drug conjugates (ADCs). We expect ADCs and auto-injector assembly capabilities to be operational by the end of 2026.”

The site will enable Recipharm to offer domestic manufacturing for US customers while granting the company access to new capabilities, including assembly lines, IV bags, and antibody drug conjugate (ADC) fill/finish. Additionally, the partnership mitigates risk for customers seeking dual or multi-site production while maintaining supply-chain resilience.

“We continue to observe strong demand for sterile injectables, including vials and pre-filled syringes/cartridge, across both small and large molecules. The market for these products is growing, driven by advancements in biologics and complex therapies,” the spokesperson added.

The financials of this partnership were not disclosed.

ReciBioPharm, LenioBio to expedite CEPI's 100 Days Mission

ReciBioPharm, Recipharm’s biologics and advanced therapy medicinal product (ATMP) development division, will produce protein to expedite vaccine production for LenioBio.

A part of Coalition for Epidemic Preparedness Innovations (CEPIs) 100 Days Mission, the collaboration will scale up the production of LenioBio’s ALiCE protein expression technology.

“Being involved in the 100 Days Mission is both an honor and a significant responsibility," said André Goerke, CEO of LenioBio. “Our collaboration with ReciBioPharm brings us one step closer to making the vision of rapid vaccine development a reality. By transferring protein production with ALiCE to ReciBioPharm, we aim to meet the urgent need for swift vaccine production, crucial for containing emerging health threats.”

LenioBio has successfully demonstrated ALiCE’s ability to produce vaccine-relevant proteins at small scales. ReciBioPharm will use ALiCE to produce 10 L protein for a vaccine candidate at its Oeiras, Portugal facility.

"Our collaboration with LenioBio represents a significant step forward in recombinant protein manufacturing. LenioBio’s ALiCE technology is well-positioned to make a meaningful impact on global health and accelerate the development of vaccines and other critical biologics,” Vikas Gupta, president, ReciBioPharm said.

CEPI’s 100 Days Mission aims to produce safe and effective vaccines within 100 days of an epidemic. In February 2024, Serum Institute of India (SII) became the fourth member of CEPI’s global network after Aspen Pharmacare in South Africa, Institut Pasteur de Dakar in Senegal, and Bio Farma in Indonesia. SII received $30 million from CEPI to help advance vaccine preparedness amongst Global South countries for future outbreaks against Disease X. Meanwhile, in April 2024, CEPI committed up to $145 million to support BioNTech’s establishment of manufacturing capabilities in Kigali, Rwanda, advancing messenger RNA (mRNA) Mpox vaccine development.