CDMO Recipharm has installed a novel modular sterile filling system at its site in Wasserburg, Germany.
The technology has been specifically tailored to support process development, as well as pilot scale and clinical supply — and is now fully operational.
Recipharm's new system is contained within a Grade A isolator, allowing for GMP-compliant aseptic filling.
According to the company, the technology can deliver between 500 to 50,000 units per batch and features interchangeable modules; meaning it can support a range of product types, including pre-filled syringes and vials.
It has also been designed to be cost- and material-efficient by limiting the loss of high value products to less than 500mL.
Notably, this unit is optimised for small-batch production, making it ideal for clinical development in rare disease indications.
“With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs," noted 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.”
The system has already successfully completed its first production run after its installment in the sumer.