Our fully licensed GMP (good manufacturing practice) facility uses an established approach to project management and allows us to successfully deliver commercial contracts to a range of clients who require a variety of cell and tissue manufacturing.
Based at the International Centre for Life, our qualified scientists and technicians are experienced in cell culture, isolation, selection, cryopreservation, and aseptic manufacturing.
Our multi-disciplinary team works closely to ensure GMP-compliant release of safe and quality medicines.
We can support the full development pathway of advanced therapy products from consultancy advice, document preparation, technology transfer, process validation, manufacturing, quality control, and the final product release.
As part of the pharmacy directorate of Newcastle Hospitals, we have a dedicated Qualified Person (QP) with significant experience in the field.
Our work is underpinned by a robust quality management system, access to clinical expertise and a supporting infrastructure from within Newcastle Hospitals and Newcastle University.
We work on a wide range of complex projects including tissue-engineered cell therapies, autologous expanded stem cell therapies and the development of somatic cell approaches to therapeutics.
We have the in-house capability to work with clinicians and scientists to deliver unlicensed medicines under our regulatory framework and work with clients to develop research ideas, implement pilot studies and build real world evidence to develop new commissioned services.
Quality control
Our service is supported by dedicated quality control staff, who have the expertise and ability to provide solutions to complex requirements for the validation and reproducibility of advanced therapy products.
Through a combination of in-house capabilities and access to MHRA regulated contract-laboratories we have the knowledge to overcome the technical challenges relating to complex manufacturing.
Our team has access to multiple flow cytometry platforms capable of complex flow panel analysis, cytotoxic detection, potency and purity assays.
We are proficient in genetic analysis for DNA and RNA extraction, including DNA karyotyping and cell culturing for functionality assays, support for in-process manufacturing and process development leading to validation, clinical manufacture, and subsequent final product release.
In combination with our specialised GMP production staff, our qualified person and quality assurance manager, the team ensures reproducible GMP-compliant release of safe, high quality medicines.
