Cellular Therapies and Stem Cells Cellular Therapies and Stem cells are an exciting and innovative technology. This raises many issues, including manufacturing and regulatory requirements, when compared with the manufacture and development of traditional biopharmaceuticals such as recombinant proteins and vaccines. Angel Biotechnology's licensed facility in Edinburgh, specialising in the manufacture of cell based therapies and mammalian fermentation, is rapidly becoming a centre of excellence for stem cell manufacturing. The facility, located at Pentlands Science Park, Edinburgh, was licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in July 2005 under the European Clinical Trials Directive (2001/20/EU). This licence specifically states that Angel can manufacture cellular therapies and stem cells for use in clinical trials. All clinical trials within Europe are subject to the requirements of this directive and Angel's Manufacturing Licence for Investigational Medicinal Products (IMPs) authorizes Angel to manufacture biopharmaceuticals to be used in clinical trials. The facility boasts 3 independent manufacturing suites allowing simultaneous multi-use for handling Category II class organisms. A single HVAC system provides HEPA filtered air into each of the rooms.
Fermentation capabilities include a 30L, BioFlow 5000 fermenter and a Microlift, 30L Cell Culture Bioreactor System. The BioFlow 5000, with a working capacity of 25L, can be employed for batch or fed batch culture.
Being based in Central Scotland, a region renowned throughout the world for stem cell research, enables us to recruit high quality, experienced personnel. Our close links to international airports mean that Angel is ideally placed to send clinical trial material throughout Europe as well as to North America. The mammalian cell culture team at Angel has extensive experience in cell line selection, cloning, cell banking and cell fermentation process development with primary human stem cells and autologous cell therapies to guarantee the success of your project. Our development, production and quality departments work closely with our customers to ensure a smooth technical transfer of process from customer to development and on to scale up for cGMP manufacturing. Fermentation and culture processes are developed in our non-GMP cell culture suites, housing Wave bioreactors or up to 10L fermenters. Only once a process has been shown to be fully reproducible it is transferred from development to larger scale cGMP manufacture. This helps maintain flexibility during the development process and cuts down on costs by reducing time spent in a cGMP facility. Our areas of expertise include: - Stem cell Isolation and derivation from autologous and allogeneic sources
- Preparation of cell lines in a validated facility
- Development of ex vivo stem cell expansion processes including differentiation and production to ensure that large numbers of homogenous cells are produced under reproducible conditions
- Process scale up
- Production of Master Cell Banks (MCB) and Working Cell Banks (WCB)
- cGMP-compliant manufacture facilities
- Sourcing of a reliable contractor for Biosafety Testing
Using our expertise we have worked on a wide range of projects producing cells for implant in clinical studies and for regenerative therapies.
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