White Raven, a newly established CDMO specializing in GMP formulation and aseptic fill & finish services for clinical and orphan drugs, has announced its successful Good Manufacturing Practice (GMP) certification. This major milestone emphasizes White Raven’s commitment to delivering safe, flexible, and accelerated manufacturing solutions for life-saving medicines.
The facility features Cytiva’s SA25 aseptic filling workcell, a fully automated system enhancing sterility assurance and minimizing contamination risks, making it Europe's first GMP-certified facility using this cutting-edge technology. White Raven joins a growing list of Cytiva SA25 users which have achieved GMP certification or received commercial manufacturing approvals from a variety of health authorities, including the FDA (United States), NMPA (China), Health Canada, HSA (Singapore), and now for the first time European Medicines Agency (EMA) success. By eliminating human interaction, it manages to remove contamination risks, offering enhanced sterility assurance, higher product quality, and a reduced risk of contamination.
New EUDRALEX Annex-1 compliance
White Raven’s GMP certification has been processed under the new EUDRALEX Annex-guidelines that were enforced in 2023, demonstrating alignment with the latest, and most stringent, requirements for sterile medicinal product manufacturing. This sets a precedent for best-in-class aseptic operations, validating the company’s strategic investments and rigorous approach to quality.
Source: https://whiteraven.bio
Bron: White Raven