GMP Cellular Therapy Facility
Roslin Cells has a 10,000 ft2 (930 m2) state of the art clean room facility for the development and manufacture of new cell therapies. Consisting of seven independent suites with supporting quality control laboratories and cryostorage facilities, the facility has been designed to handle several therapies at the same time. The facility is capable of accommodating novel or bespoke closed processing technologies as well as conventional ‘open’ cell processing.
The design and operation of the facility have been developed to meet the latest European regulatory standards for Advanced Therapy Medicinal Products (ATMPs). The facility and its operators will hold the relevant licenses from the Medicines and Healthcare products Regulatory Agency (MHRA), the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) for the storage, processing and manufacture of almost all tissue types and cell therapies.
The facility is available to companies and academic researchers wishing to develop new cell therapies. Roslin Cells has established a multidisciplinary team who can provide support with all stages of the product development process, from early research to GMP manufacture of cell therapy products for up to Phase II clinical trials.
Main Features:
- Highly experienced staff
- 7 independent fully GMP validated clean room suites
- Three HVAC systems for independence and continuity of processing
- Flexibility of grade A against B, or grade A against C/D environments
- State of the art MBSCs with in-built microscopes for open processing
- Dedicated space for bioreactors/isolators and closed processing technology
- O2 and CO2 controlled incubation
- LN2-free controlled rate freezing
- LN2-free cryostorage
- LN2 vapour phase cryostorage
- Dedicated quality control laboratories including tissue culture and environmental monitoring
- GMP compliant Quality Management System
