SCM Pharma is UK-based pharmaceutical contract manufacturing organisation (CMO) that works with clients progressing drugs through clinical trials and others that require low volume commercial supply of niche licensed products.
Specialising in novel, difficult and dangerous products requiring complex fill/finish, the specialist CMO provides a wide range of development, manufacturing and packaging services to meet client needs.
With specific expertise in custom manufacturing and sterile fill/finish, SCM Pharma is able to handle 14C radiolabeled compounds and highly potent products including cytotoxics. The award-winning CMO can fill liquids, gels and powders in a range of final dosage forms including ampoules, vials, cartridges, syringes and bottles.
Working with top 10 big pharma, speciality pharmaceutical companies, small biotech firms, virtual companies, public sector bodies and academic institutions across Europe and North America, SCM Pharma operates from MHRA-licensed facilities to current GMP regulations.
Its specialist offerings include:
- Process development
- Aseptic processing (using isolator technology)
- Non-aseptic processing followed by terminal sterilisation
- Fill/finish of 14C radiolabeled compounds
- Fill/finish of highly potent products including cytotoxic and cytostatic formulations
- Drug/medical device filling and assembly
- In-house testing including sterility, endotoxin, microbiology and analytical chemistry
- ICH stability testing
- Clinical packaging and distribution
- QP release
Privately -owned, SCM Pharma's corporate HQ and manufacturing facilities are located in Northumberland in the UK with a commercial office in New Jersey, USA.
Its state-of-the-art, purpose-built 17,000 sq. ft. facility was specifically designed to satisfy the needs of clients that require Investigational Medicinal Products (IMPs) or commercial supplies of niche licensed medicines such as orphan drugs. The firm's expanding facility will be inspected by the FDA in 2011 and includes:
- Seven cleanrooms - all Grade C (class 10,000)
- Aseptic processing isolators
- Dedicated suites for handling potent materials
- Formulation, analytical and microbiology laboratories
- Batch sizes up to 200 Litres
- Inspection areas
- A range of packaging areas
- Temperature controlled warehousing
The company also offers gateway assistance to North American firms with the EU approval required for distributing drug products from North America into Europe. Whether a product for clinical trials or commercial supply, the CMO can provide gateway testing and QP release to give products the approval required for European distribution. For Europe-based clinical trials, it provides rapid tech transfer, manufacturing, testing and release to reduce costs and time to market.
|SCM aims to provide its clients with the right quality products within an agreed timeframe and budget. All work is closely monitored for quality performance and the company's highly trained staff work within stringent quality control systems. It is this quality service, plus its flexible and positive approach, that makes the company stand apart from its competitors.|