White Raven increases manufacturing efficiency and flexibility
White Raven installs Cytiva’s SA25 Aseptic Filling Workcell to reduce the risk of product contamination and handle multiple formats
22 Mar 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 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.
White Raven provides a large range of formulation services adapted to clinical batches, with capabilities to work with mixing volumes as low as 50 mL and up to 20 L. 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.
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.