10 October 2008
About SCM Pharma
SCM Pharma is this year making its hat-trick of appearances at ICSE with two new revolutionary services to boot! Officially launching Radiopharma and Biologicals (see enclosed press information) SCM has grown massively in the past few years and is continuing to reinforce its presence and credibility with pharmaceutical, bio and healthcare companies right across the globe.
Since it was established in 2004, SCM has continually expanded its portfolio of niche contract outsourcing solutions, offering a wide range of small-medium scale development, manufacturing, filling, packaging, technical support, testing and quality services for its clients’ clinical trial and commercial needs.
Based in North East England, SCM’s 17,000 sq ft world class purpose-built facility provides some of the most advanced cleanroom laboratories in the UK, designed with both the quality and flexibility to meet the full spectrum of clinical trial manufacturing requirements for Phase I-III studies.
With a vision to be different and offer a truly bespoke service, the SCM team is a group of experts, including numerous trained pharmacists, with decades of experience across the entire field of pharmaceutical manufacturing.
Working closely with small-medium companies and top 20 pharma throughout the clinical trials process and adhering to stringent quality standards, SCM offers a professional project management service and a friendly, flexible approach, adapting to meet the specific needs of individual clients.
SCM services
Established as a Centre of Excellence, SCM offers a range of sterile and non-sterile manufacturing, filling and packing services, including aseptic and terminally sterilised vial, ampoule and syringe filling, for the clinical trials and scale-up commercial markets.
Batch sizes can be created to any scale as required, from one unit upwards. Depending on their needs, clients can elect to use SCM’s full range of professional project management services or select individual modules of the company’s capabilities.
Packaging services are also available and include blinded and unblinded labelled patient packs, blister packaging for pharmaceutical products, packaging for commercial purposes and clinical packaging. Finished goods can be delivered to any address across the world.
With a number Qualified Persons (QPs) on site, additional services include equipment and process validation, method development, stability testing, batch review and release and auditing. Both the technical and regulatory release of investigational medicinal products (IMP) can also be performed on behalf of clients.
The facility
Specifically designed to meet the high standards required for a clinical trial manufacturer, SCM’s facility allows sterile and non-sterile manufacturing, development and packaging within class c (class 10,000) cleanrooms, catering for batch sizes from one unit to around 200kg or litres and includes:
- Six cleanrooms
- An area for handling toxic/potent areas
- Sterile filling facility
- Aseptic processing suites/isolators
- Inspection areas
- Formulation laboratory
- Temperature controlled warehousing area
s - Microbiology laboratory
- Analytical laboratory and testing facilities
- Range of packaging areas
- Cold storage facility
- Clinical trial materials processing and shipping
- QP Release
- Freeze-drying (in 2009)
Quality
Complying with cGMP, 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 and motivated staff work within stringent quality control systems. It is this quality service, plus its flexible and positive approach, that makes SCM stand apart from its competitors.
People
Brian J Dougherty - Co-Founder, Chairman and General Manager
With more than 30 years’ experience in quality assurance, manufacturing and research & development, Brian has a breadth of expertise across the pharmaceutical sector, particularly in sourcing and dealing with pharmaceutical contract manufacture. A registered pharmacist, achieving QP status in 1983 under current regulations, Brian set up SCM in 2004 (sister company of The Specials Laboratory) with renowned business partner Fiona Cruickshank.
Shirley Dann - Business Development Director
Shirley is an experienced director and registered Pharmacist with over 25 years’ experience in the pharmaceutical industry. She has held senior positions in the areas of production, product development, product licensing and quality assurance, having previously worked at Fisons, RPR and Nova Laboratories. Playing a pivotal role as Business Development Director, Shirley works closely with clients from the outset to the finish line, ensuring manufacturing needs and project objectives are met.
Howard Gray - Operations Manager
Responsible for running SCM's day-to-day operations to cGMP standards, Howard has over 30 years’ experience working in the pharmaceutical and medical device industry. He has held a number of senior management positions across sterile production, packaging, engineering, semi-solids, solid dose, validation and quality and has an excellent understanding of process variations, regulatory requirements and commercial expectations.
Elaine Mackie - Contracts Manager
With over a decade of experience in NHS research and hospital pharmacy, plus industrial positions in pharmaceutical dispensing, sterile manufacturing, clinical trial design, packaging and supplies, Elaine heads up the packaging side of the business. Her role involves managing projects using existing technologies within the business while providing support to the business development function.
MEDIA CONTACTS:
For more information on SCM and/or interview opportunities please contact:
Liz Davies or Georgina Dunkley
Golley Slater PR
T: +44 191 233 9062 / +44 191 233 9062
Visit us!
We actively encourage and welcome journalists to visit our state-of-the-art home in North East England. Please contact Liz or Georgina (above) to organise a visit.
Contact us:
Unit 6 Regents Drive,
Low Prudhoe Industrial Estate,
Northumberland, NE42 6PX.
T: +44 (0) 1661 833 693
F: +44 (0) 1661 835 010
Low Prudhoe Industrial Estate,
Northumberland, NE42 6PX.
T: +44 (0) 1661 833 693
F: +44 (0) 1661 835 010
