The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations.
The factory, which will be located on a 42 hectare greenfield site is planned to be operational by 2023, will be run by Recipharm and will mirror the company’s new fill finish line at its facility in Monts, France on a larger scale.
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
AGC Biologics announced the signing of a purchase agreement for a state-of-the-art Cell and Gene Therapy commercial manufacturing facility in Longmont, currently owned by Novartis Gene Therapies.