Janet Downie – CEO, Roslin CT, UK
A spinout from the Roslin Institute that created Dolly the Sheep, Roslin CT is a cell and gene therapy CDMO, with a unique positioning in the field today. Its CEO,…
Address: Unit 6 Regents Drive,
Low Prudhoe Industrial Estate, Northumberland.
NE42 6PX.,United Kingdom
Tel: +44 (0) 1661 833 693
Web: www.scmpharma.com
SCM Pharma is a UK-based contract development and manufacturing organisation (CDMO) that develops and delivers novel, difficult and dangerous drugs on behalf of its clients. The company works with clients progressing drugs through the pre-clinical formulation stage, clinical trials and others that require low volume commercial supply of niche licensed products.
Privately-owned, SCM Pharma’s corporate HQ and MHRA-licensed manufacturing facilities are located in North East England with recently acquired additional laboratory space within the University of Sunderland’s state-of-the-art £8.5m science complex. Its clients include top 10 big pharma, speciality pharmaceutical companies, small biotech firms, virtual companies, public sector bodies and academic institutions from across Europe and North America.
With specific expertise in custom formulation, complex cGMP sterile manufacturing and aseptic filling, the award-winning CDMO is able to handle 14C radiolabeled compounds and potent products including cytotoxics. Its specialist offerings include –
• Process development
• Formulation development
• Aseptic processing (using isolator technology)
• Non-aseptic processing followed by terminal sterilisation
• GMP filling of 14C radiolabeled compounds
• Fill/¬finish of highly potent products including cytotoxic and cytostatic formulations
• Drug/medical device fi¬lling and assembly
• In-house testing including sterility, endotoxin, microbiology and analytical chemistry
• ICH stability testing
• Clinical packaging and distribution
• QP release
SCM Pharma can fill liquids, gels and powders into a range of final dosage forms including ampoules, vials, cartridges, syringes, bottles.
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