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news.Scorpius Holdings, an integrated contract development and manufacturing organisation (CDMO), has confirmed the successful current Good Manufacturing Practice (cGMP) facility validation for microbial manufacturing.
The latest milestone means that the company’s microbial facilities are now qualified for the production of cGMP microbial biologic drugs. Credit: Testalize.me on Unsplash.
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The latest milestone means that the company’s microbial cleanrooms are now qualified for the production of cGMP microbial biologic drugs.
The validation of Scorpius’ microbial cleanrooms has already attracted a backlog of bookings from client programmes.
Scorpius said that this achievement further highlights its capability to meet the high standards required for contract manufacturing of microbial biologics.
Scorpius Holdings CEO Jeff Wolf said: “Scorpius has experienced strong interest in our microbial capabilities, and we continue to add additional opportunities to our pipeline for 2024 and 2025.
“This validation confirms our commitment to high-quality, state-of-the-art microbial production. We are dedicated to leveraging our advanced capabilities to support our clients’ needs and contributing to the advancement of breakthrough therapies.”
In addition to the microbial cleanrooms qualifications, Scorpius is enhancing its operational efficiency by transitioning all its environmental monitoring responsibilities to internal teams, rather than depending on third-party services.
This strategic move is expected to improve efficiency and further strengthen Scorpius’ existing capabilities to deliver improved biomanufacturing services.
Wolf added: “This validation is a testament to Scorpius’ rigorous quality standards and our dedication to supporting the development and manufacturing of microbial products. With this achievement, Scorpius is poised to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service.”
Scorpius Holdings specialises in advancing biologic and cell therapy programmes to the clinic and beyond.
The company offers a wide range of process development, analytical testing, as well as manufacturing services to pharmaceutical and biotech companies from its different facilities located in San Antonio, Texas, US.
