Specials Clinical Manufacturing (SCM) offers a wide range of small-medium scale development, manufacturing, filling, packaging, technical support, testing and quality services providing outsourced solutions for clinical trial and commercial needs. Its portfolio of services is now being enhanced following MHRA approval for filling radio-labelled and biological products.
The new radiopharma service will assist companies at both pre-clinical and clinical stages of development. Given the rising costs associated with developing new drugs and bringing them to market, and the current industry statistics that demonstrate fewer new products are being licensed each year, it is even more important to identify those drug molecules that have commercial worth. SCM recognises that by offering compounding, handling and filling services for radio-labelled materials, it will add true value to its clients" business.
Studying radio-labelled compounds, particularly in the pre-clinical phase, can reduce the development cycle, cut costs and lead times through early identification of where and how compounds act in the body and what the drug concentrations are at certain time points. This may allow potentially harmful drugs to be detected and eliminated from the development portfolio at an earlier stage, reducing expenditure on unsuitable drug candidates or identifying the most effective candidate.
Over the past 10 years, there has been significant growth in the development of biological molecules and, as a result, SCM has recognised the importance of offering aseptic filling using isolator technology.
Within the past year, the company has developed the infrastructure and up-skilled a number of its staff members to offer biological filling. The use of sealed gas isolators provides the highest form of protection for aseptic products and has also been shown to provide a higher level of sterility assurance than traditional aseptic process filling.
"The introduction of both new services will help establish us as a centre for excellence in small-medium scale sterile work, in areas such as radio-labelling, biologicals, aseptic processing and the handling of cytotoxics and cytostatic products," said Brian Dougherty, chairman of SCM.
Based in a state-of-the-art facility, SCM offers sterile and non-sterile manufacturing services, including ampoule, vial and syringe filling (aseptic and terminally sterilised), and a range of packaging services including clinical packing. The company can create batch sizes as small as one unit, up to around 50kg/200 litres. Depending on their requirements, clients can select individual modules of the company's capabilities or elect to use its full range of professional project management services if a fully outsourced solution is preferred.