Installation of Cytiva’s Aseptic Filling Workcell Aimed at Raising White Raven’s Manufacturing Efficiency

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva's SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s drug product platform and increase its manufacturing efficiency. White Raven’s site is expected to be good manufacturing practice (GMP)-compliant by the end of 2024.

SA25 is an integrated gloveless robotic isolator that eliminates the need for operator intervention, according to a company press release. The system is designed to provide an optimal aseptic process and comprises a standardized flexible filler that is capable of producing vials, syringes, and cartridges in batch sizes ranging from 100 to up to 20,000 units. The system has a fill-volume range of 0.2 mL – 50 mL. Because it is a closed robotic system, it reduces the risk of product contamination. It also allows for changeover between drug formats within a 45-minute timeframe.

Ludovic Brellier, president, Biotechnology Integrated Solutions and Business Operations, Cytiva. Image courtesy of Cytiva.

“White Raven recognizes that by replacing a human operator with a robotic gloveless isolator, they can remove the biggest risk for contamination—ensuring they are taking the right steps to protect customers’ high value drug products. The need for greater standardized solutions to improve this process is a trend we are seeing across the industry,” Ludovic Brellier, president of Biotechnology Integrated Solutions and Business Operations, Cytiva, says.

White Raven offers a range of formulation services adapted to clinical batches and is capable of working with mixing volumes as low as 50 mL and up to 20 L. The CDMO also offers GMP formulation and aseptic filling of injectable drugs for pre-clinical, clinical, and orphan drugs. White Raven employs single-use consumables over the full aseptic filling process to also reduce contamination risk.

The company is part of Cytiva’s aseptic filling user group, which is a group that works closely with Cytiva to collaborate on best practices, such as system validation and operations. White Raven expects the installed workcell to complete a site acceptance test by mid-2024, prepping the site for GMP readiness by end of the year.

Considerations for improving aseptic operations in the bio/pharma industry are an ongoing exercise for manufacturers. Automation technologies have been a major solution in this area. However, in one sense, automated aseptic processes can be seen as “often playing catch up to the new tools that are being developed,” according to Dan Strange, chief technology officer at Cellular Origins, in a Pharmaceutical Technology® Drug Digest video interview (1). “These consumables and equipment … have been fundamentally designed for manual processes … and that's very hard to automate. It's … straightforward for a manual operator to automate, but it's hard for traditional automated systems to handle that,” Strange noted in the interview.

Reference

1. Murphy, J. Drug Digest: Improving Aseptic Processing and Manufacturing Needs. PharmTech.com, Aug. 24, 2023.

Source: Cytiva and White Raven