Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale & Clinical Supply

Recipharm recently announced a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany. This advanced system performs aseptic filling within a Grade A isolator and operates in full compliance with GMP standards.

The system offers unmatched flexibility, featuring interchangeable modules that support various product types, such as syringes and vials. An additional pre-filled syringe (PFS) module is being added to the installation, broadening the system’s capabilities and cementing its position as a versatile and reliable solution for pharmaceutical and biotech companies alike.

The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product. In addition, the system provides great efficiencies and cost saving, by limiting the loss of high value products to less than 500mL and preserving material for clinical trials.

This new unit complements Recipharm’s existing development and commercial filling capabilities. Unlike traditional large-scale production systems, the unit is optimised for small-batch production, offering a fast and flexible solution for clinical development projects across rare disease pharmaceuticals, cell and gene therapies, and other advanced and emerging modalities with highly focused patient populations. This also makes it an excellent companion to ReciBioPharm’s Biologics and ATMP services. Additionally, when used with Recipharm’s ReciPredict, the product benefits from optimised time and cost efficiency, supporting a seamless tech transfer to commercial production.

Gregor Kawaletz, Chief Commercial Officer, Recipharm, said: “With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs. This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development.”

Having been installed during the summer, the system has successfully completed its first production run for a leading biotech company, demonstrating its reliability and potential to support cutting-edge pharmaceutical development.

For more information about Recipharm’s modular sterile filling system and how it can support your production needs, please contact Vincenza Pironti, head of business development: Vincenza.Pironti@recipharm.com

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 and is headquartered in Stockholm, Sweden.

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