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Swedish contract development and manufacturing organization (CDMO) Recipharm has added a sterile filling system at its Wasserburg facility in Germany. The system operates within a Grade A isolator.
According to the firm, the isolator allows for fast and easy exchange of modules, enabling Recipharm to configure client-specific production requirements. Moreover, the new line is designed for smaller batches, making it suitable for clinical development.
“The closed isolator system reduces the risk of contamination, resulting in fewer rejected batches,” a spokesperson for Recipharm told BioProcess Insider.
“With both piston and peristaltic pumps, it provides high precision filling, [with] minimal overfill and product waste. The system also allows for adjustments of fill volumes with high accuracy which leads to reduced product loss in small, high-value batches.”
The newly installed system supports pre-filled syringes and liquid vials, through interchangeable modules. Additionally, the platform minimizes high-value product loss to less than 500 ML in clinical trials. The platform will work with Recipharm’s data-driven platform ReciPredict.
“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,” said Gregor Kawaletz, chief commercial officer (CCO), Recipharm.
The financials of this expansion were not disclosed.
The CDMO divested seven manufacturing and development facilities in April 2024, to focus on higher-margin CDMO services including biologics and fill/finish. Under terms of the deal, US-based private equity firm Blue Wolf Capital Partners acquired facilities in Solna, Stängnäs, Höganäs, Karlskoga, and Uppsala (all in Sweden), Pessac in France, and Parets in Spain. These sites will manufacture and develop oral solid, semi-solid, and liquid dosage form pharmaceutical products.
On the same day, Recipharm completed its spin-out of Bespak, a standalone organization focused on drug-device combination products and drug-delivery devices. The business included assets acquired from Consort Medical in 2020 including three facilities focused on inhaled and nasal drug-delivery products in King’s Lynn, UK, Holmes Chapel, UK, and North Carolina, US.
Recently, Recipharm collaborated with fellow CDMO Exela to produce more than 100 million units (vials and pre-filled syringes) to support emerging therapeutics such as Glucagon-like peptide-1 (GLP-1) drugs and vaccines.
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