White Raven Increases Manufacturing Efficiency And Flexibility With Aseptic Filling From Cytiva

• White Raven installs Cytiva’s SA25 Aseptic Filling Workcell to reduce risk of product contamination and handle multiple formats
• GMP readiness of White Raven’s site anticipated by the end of 2024

White Raven, a contract development and manufacturing organization (CDMO) specializing in formulation and aseptic filling, has chosen global life science leader, Cytiva for its aseptic filling needs. Cytiva's SA25 Aseptic Filling Workcell will complete White Raven’s comprehensive drug product platform, offering substantial flexibility to meet customers' manufacturing and development needs.

The SA25 Aseptic Filling Workcell is an integrated gloveless robotic isolator that eliminates the need for operation intervention. It is designed to provide an optimal aseptic process with a standardized flexible filler capable of producing vials, syringes, and cartridges with batch sizes from 100 up to 20 000 units and a fill volume range of 0.2 - 50 mL. With its closed robotic system, it reduces the risk of product contamination and can change between drug formats within 45 minutes.

Dimitri Woronoff, CEO White Raven, says: “With Cytiva’s leadership and extensive expertise in robotic, aseptic fill-finish technology, we are poised to offer flexible and reliable aseptic filling services to innovators ranging from emerging biotech firms to established pharmaceutical players.”

White Raven provides a large range of formulation services adapted to clinical batches, with capabilities to work with mixing volumes as low as 50mL and up to 20L. The CDMO offers Good Manufacturing Practices (GMP) formulation and aseptic filling of injectable drugs for pre-clinical, clinical and orphan drugs. To further mitigate the risk of cross-contamination, White Raven efficiently manages single-use consumables during the entire aseptic filling process.

Ludovic Brellier, President of Biotechnology Integrated Solutions and Business Operations, Cytiva, says: “It's not just about flexibility and standardization to improve processes - it's about patients receiving the vital therapies they need, faster. Our aseptic filling workcells will help White Raven reduce risks, thanks to a closed, robotic, and repeatable aseptic process, providing White Raven’s customers the knowledge they are providing high-quality products.”

Cytiva's technology was first to market in 2015 under the name Vanrx and was designed in accordance with EU-Annex 1 guidelines. Currently, more than 60 robotic workcells have been sold for GMP production purposes. Drug products filled on aseptic filling workcells have been approved by four regulatory agencies to date: FDA, Health Canada, Singapore PIC/S and cNMPA.

White Raven is part of Cytiva’s aseptic filling user group which works closely with Cytiva to collaborate on best practices, such as system validation and operations. Members also benefit from Cytiva’s guidance and support as they seek regulatory approval in new markets. White Raven expects their workcell to complete Site Acceptance Test (SAT) by mid-2024. White Raven anticipates obtaining GMP site readiness by the end of 2024.

More information about Cytiva’s aseptic filling technologies and solutions can be found here(https://www.cytivalifesciences.com/solutions/bioprocessing/aseptic-filling).

Information about White Raven’s services can be accessed here(https://whiteraven.bio/r/OIs).