NecstGen Announces Major Milestone – GMP Manufacturing License
1 December 2022, Leiden, today the NecstGen team is happy to announce that is has received its GMP Manufacturing License. Farmatec, part of the Dutch Ministry of Health, Welfare and Sport has granted NecstGen its license for the GMP manufacturing of Advanced Therapy Medicinal Products.
Throughout the last year, NecstGen has finalised the construction of its brand-new 4,000 m2 GMP facility on the Leiden Bio Science Park. In November, a GMP inspection was carried out by the Dutch Health and Youth Care Inspectorate (IGJ). Following the positive outcome of this inspection, NecstGen has received the license for the GMP manufacturing of ATMPs from Farmatec/CIBG, the executive body of the Ministry of Health, Welfare and Sport (VWS).
Paul Bilars, CEO said “This is a culmination, a stamp of approval, on the work of our dedicated team. It is a symbol of the high standards we aim to maintain daily, and the trust placed within us as an organisation. With the determination of our expert team and many others it has been possible to meet the standards for achieving our Manufacturing License.”
The license allows NecstGen to manufacture and release Cell and Gene Therapies for patients. As a Centre of Excellence for Cell and Gene Therapies, NecstGen aims to accelerate the development and manufacturing of this next generation of promising therapies by providing critical services. Through its GMP facility containing 13 cleanrooms, NecstGen can support academic and industrial therapy developers, offering flexibility in both scale and modality.
Find out more about NecstGen and its facility in the video below:
NecstGen is a new centre of excellence for Cell and Gene Therapy development and manufacturing, located in a purpose-built GMP facility at the Leiden Bio Science Park. NecstGen has a focused expert team and bespoke facility to offer the support and capacity needed to deliver Cell and Gene Therapies to patients. Our +4,000 m2 facility encompasses development labs and GMP suites to accommodate the manufacturing of therapies in different operational modes. NecstGen’s dedicated Viral Vector suites offer segregated inoculum, upstream and downstream processing capabilities to maximize batch throughput. The multi-use Grade B and C cleanrooms are available for manufacturing therapies, including Cell Therapies, Ex vivo Gene Therapies, and Gene Therapies. NecstGen offers complete contract manufacturing for Cell Therapy and Viral Vector and cleanroom rental for any mammalian-based therapy type.