Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale, and Clinical Supplies
Thursday, February 06, 2025
Recipharm, a global leader in contract development and manufacturing, has announced that a new modular sterile filling system, designed for process development, pilot scale, and clinical supply, is now fully operational at its advanced facility in Wasserburg, Germany. The system, which operates within a Grade A isolator, meets all GMP standards for aseptic filling.
The system offers exceptional flexibility with interchangeable modules, allowing it to handle various product types, including syringes and vials. An additional pre-filled syringe (PFS) module is being added, further enhancing the system’s versatility and reinforcing its position as a reliable solution for pharmaceutical and biotech companies.
Capable of delivering between 500 and 50,000 units per batch, the system supports all product development stages. It also offers significant efficiencies, reducing the loss of high-value products to under 500mL, which helps preserve material for clinical trials and provides cost savings.
This new unit complements Recipharm’s existing development and commercial filling capabilities. Unlike traditional large-scale systems, it is optimised for small-batch production, providing a quick and flexible solution for clinical development projects in rare diseases, cell and gene therapies, and other emerging treatments with specialised patient groups. It is also a perfect fit for ReciBioPharm’s Biologics and ATMP services. Additionally, when used with Recipharm’s ReciPredict, the system helps optimise time and cost efficiency, ensuring a smooth tech transfer to commercial production.
Installed over the summer, the system has already successfully completed its first production run for a leading biotech company, confirming its reliability and potential to support advanced pharmaceutical development.
Source: recipharm.com
