Recipharm strengthens BFS leadership with new development contracts, enabling over 90% API savings

• Recipharm is the only CDMO with Blow-Fill-Seal (BFS) capabilities for both biologics and small molecules, offering a fully integrated solution across modalities.
• Recipharm’s BFS clinical capabilities deliver over 90% API savings compared to commercial manufacturing approaches.
• BFS clinical technology supports both speed and scalability for large and small molecule formulations in clinical phase 1, 2 or 3.
• New development agreements leverage Recipharm’s BFS end-to-end capabilities from clinical development to commercialisation.

Recipharm, a leading global contract development and manufacturing organisation (CDMO), has secured major product development contracts, further solidifying its leadership in Blow-Fill-Seal (BFS) technology.

Recipharm holds a unique position in the industry as the only CDMO offering BFS capabilities across both biologics and small molecules, enabling truly integrated development pathways for complex products, from early phase development through to commercialisation. BFS technology is applicable across diverse therapeutic areas, including vaccines, ophthalmology and pulmonary delivery, reflecting its versatility and adaptability to complex formulation needs.

Recipharm's BFS clinical capabilities provide a strategic advantage by enabling rapid, small-scale cGMP manufacturing, tailored to early-phase clinical development requirements. Batch sizes starting at just 200ml allows over 90% API savings compared to other manufacturing platforms, a crucial benefit in early-stage development when API cost can be a major constraint. The scalable nature of the BFS platform ensures a seamless transition through clinical phases and toward commercial readiness.

The first of the new contracts, with a top 5 global ophthalmic organisation, involves the rapid production of clinical trial material (CTM) for a Phase 1 study. Recipharm's BFS clinical expertise, including the Lab+ pilot scale technology, will enable fast and efficient turnaround of small volume, cGMP-compliant batches.

Simultaneously, Recipharm has entered into another agreement with a global ophthalmic biotech to support a Phase 2/3 ophthalmic suspension programme, also leveraging Recipharm's BFS clinical expertise to deliver high quality clinical material with speed and precision.

Vincenza Pironti, Recipharm's Head of Business Development, commented: "These partnerships highlight Recipharm's position as a trusted partner from early clinical development through to commercialisation. Recipharm's BFS clinical platform is designed for speed, adaptability and efficient API use, enabling the delivery of high quality clinical trial material across Phases 1, 2 and 3. Combined with our specialist expertise, we are empowering clients to bring innovative products to market faster and with greater confidence."

Recipharm's BFS facility is at the forefront of advanced manufacturing for both biologic and small molecule products. The company's continued investment in BFS product development and manufacturing capabilities underscores its commitment to providing agile, end-to-end support from early development through commercialisation.

Blow-Fill-Seal is an advanced aseptic manufacturing technology in which containers are formed, filled, and sealed in a single, continuous process within a sterile, closed system. This minimises the risk of contamination and the need for human intervention. BFS is highly efficient and supports rapid scale-up, making it ideal for transitioning from clinical trial material to full commercial production of unidose products. It also offers cost advantages through reduced component use, limited operator intervention in process handling and simplified cleaning requirements. The technology is highly flexible, accommodating a wide range of formulations and packaging configurations for biologics and small molecules as suspensions, solutions and emulsions. It is suitable for various therapeutic areas, including vaccines, ophthalmologic and pulmonary delivery applications. For patients, BFS provides safe and convenient packaging: it ensures accurate dosing, removes the need for preservatives and delivers lightweight, shatterproof containers that are easy to transport.

The recent agreements tap into Recipharm's four ophthalmic key areas of expertise: BFS; Pre-Filled Syringes (PFS); Oral solid technologies; and comprehensive product development services (including analytical and stability support).

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About Recipharm
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,000 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and pharmaceutical product development. Its ReciBioPharm division works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical development, commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US.

For more information on Recipharm, please visit www.recipharm.com and www.recibiopharm.com

Media contact:

Guenaelle Holloway, Head of communications
[email protected]
+44 7730 303 708