Quotient Sciences Bolsters Sterile Fill/Finish Capacity
Quotient Sciences, a drug development and manufacturing accelerator, has invested significantly in expanding its sterile fill/finish capabilities at its Alnwick, UK facility. This expansion aims to meet the rising demand in the industry for comprehensive drug development programs by enhancing the capacity of the Annex 1-compliant facility.
The company operates advanced contract development and manufacturing (CDMO) facilities in the US and UK, seamlessly integrated with clinical testing sites in Nottingham (UK) and Miami (US), ensuring remarkable cost and time efficiencies.
This recent investment significantly enhances the Alnwick facility by tripling its Grade C cleanroom count from one to three. The expansion includes the adoption of new isolator technology for larger batch sizes and shorter manufacturing cycles. Furthermore, the facility boasts an in-house microbiology team to expedite testing and environmental monitoring, with plans for further microbiology lab investments next year.
Gareth Jenkins, VP Science & Technology at Quotient Sciences, commented, “Navigating the development, analytical, and new Annex 1 regulatory requirements for sterile/aseptic drugs can be complicated, but with these enhancements, we have the specialized expertise and dedicated facilities to ensure successful and timely program delivery."
With 30+ years of experience, Quotient Sciences specializes in sterile parenteral drug product development, from candidate inception to clinical trial manufacturing. Their Translational Pharmaceutics platform integrates all aspects and allows for real-time decision-making based on clinical data, resulting in faster development, reduced risk, and lower costs.
Thierry Van Nieuwenhove, CEO of Quotient Sciences, added, “At Quotient Sciences, our mission is to help get new medicines to patients faster. By increasing our capacity for sterile fill/finish operations, investing in new technologies and expanding our team, this enables us to further support our customers with fully integrated Translational Pharmaceutics programs for sterile product development, which reduces development risks, shortens timelines, and improves the chances of success.”
