Recipharm reports that a new modular sterile filling system specifically tailored for process development, pilot scale, and clinical supply, is now fully operational at its facility in Wasserburg, Germany.
The company says this system performs aseptic filling within a Grade A isolator and operates in full compliance with GMP standards and offers 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.
The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product, notes Gregor Kawaletz, COO, Recipharm, who adds that the system provides great efficiencies and cost savings, by limiting the loss of high-value products to less than 500 mL 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 optimized for small-batch production, offering a 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, continues Kawaletz.
This also makes it a companion to ReciBioPharm’s Biologics and ATMP services and, when used with Recipharm’s ReciPredict, the product benefits from optimized time and cost efficiency, supporting a seamless tech transfer to commercial production, according to Kawaletz.
“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,” he says.
