Quotient Sciences will expand its Alnwick, UK fill/finish facility to support integrated drug development programs.
Contract development and manufacturing organization (CDMO), Quotient aims to increase the capacity of the fill/finish facility in Alnwick in the North of England by increasing the number of grade C cleanrooms from one to three.
“Our translational pharmaceutics platform is enabled by rapid and agile clinical trial manufacturing and this expansion builds capacity to support an increasing number of programs with sterile manufacturing requirements,” Gareth Jenkins, VP of science & technology at Quotient Sciences told BioProcess Insider.
c/o Quotient Sciences
Also, the firm has invested in isolator technology, enabling larger batch sizes and reduced cycle times per manufacturing campaign kept under supervision of a team of microbiologists who will test and monitor the batches.
According to the firm, the deal aims to progress the early phase clinical development candidates through the sterile fill/finish capacity employing single-use product contact lines and ready-to-use pre-sterilized vials.
“All of the work to the cleanrooms and the filling equipment is installed and qualified. Our manufacturing operators are currently completing a series of aseptic process validations to ensure all the systems, training, and procedures are fully GMP compliant. We then have several clinical manufacturing batches lined up, starting in December 2023 and scheduled well into the middle of 2024,” said Jenkins.
Sterile drug product manufacture falls under annex I of the ICH Q7 drug product manufacturing GMP regulatory guidelines and these were significantly revised after 15 years since their last review. The new revision came into effect in August of this year with much more emphasis on a contamination control strategy being implemented to assess and reduce risk in the aseptic manufacture.
You May Also Like
