Recipharm has announced that 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.