Recipharm Unveils Modular Sterile Filling System at Wasserburg Facility

• Recipharm has launched a modular sterile filling system at its Wasserburg, Germany facility, supporting process development, pilot-scale, and clinical supply.

• The system is GMP-compliant, highly flexible, and designed for small-batch production, with the capacity to produce 500 to 50,000 units per batch.

Recipharm, a global contract development and manufacturing organisation (CDMO), has announced that its new modular sterile filling system is now fully operational at its Wasserburg, Germany facility. The system is designed to support process development, pilot-scale, and clinical supply manufacturing, operating within a Grade A isolator and in full compliance with GMP standards.

The new system provides enhanced flexibility with interchangeable modules capable of handling different product types, including syringes and vials. An additional pre-filled syringe (PFS) module is also being integrated, further expanding the platform’s capabilities for pharmaceutical and biotech clients.

The filling line accommodates batch sizes ranging from 500 to 50,000 units, making it suitable for all phases of product development. Its design prioritises efficiency, minimising product loss to under 500mL and preserving valuable materials for clinical trials. Unlike traditional large-scale systems, this unit is optimised for small-batch production, catering to rare disease pharmaceuticals, cell and gene therapies, and other advanced modalities requiring tailored manufacturing solutions.

This installation complements Recipharm’s existing development and commercial filling services and aligns with its ReciBioPharm Biologics and ATMP offerings. Additionally, when used alongside Recipharm’s ReciPredict platform, it supports optimised time and cost efficiency for a seamless transition to commercial production.

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