About SCM Pharma
UK-based SCM Pharma offers a wide range of small-to-medium scale sterile and non-sterile manufacturing, development, packaging and filling services, providing outsourced solutions for its clients’ commercial and clinical trial needs.
Firmly established as a Centre for Excellence, the company, located in North East England, is housed in a state-of-the-art custom built facility, ergonomically designed with quality and flexibility in mind.more
In July 2008, SCM Pharma received MHRA approval for filling radio-labelled products. The radiopharma service is being launched to 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 Pharma recognises that by offering compounding, handling and filling services for radio-labelled materials, it will add true value to its clients’ business.
The benefits of studying radio-labelled compounds, particularly in the pre-clinical phase can be considerable. By reducing the development cycle, costs and lead times can be shortened through for example, early identification of where and how they 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 identify the most effective candidate.
Biological Filling: Sterility Assurance
Over the past 5 – 10 years, there has been significant growth in the development of biological molecules for human medicinal use. As traditional small molecule ‘blockbuster’ drugs are becoming harder to identify and scientists’ understanding of how drugs work at a molecular level within the body, has increased, we have recognised the importance of offering aseptic filling using isolator technology.
As such, within the past month, 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 provide the highest form of protection for aseptic products and has shown also to provide a higher level of sterility assurance than traditional aseptic process filling.
Sterile and Non-Sterile Manufacturing Specialist
SCM Pharma also offers sterile and non-sterile manufacturing services, including aseptic and terminally sterilised vial, ampoule and syringe filling. The company is also able to handle a variety of toxic products, including cytotoxics.
Additionally, a range of packaging services are available including blinded and unblinded labelled patient packs, blister packaging for pharmaceutical products, packaging for commercial purposes and clinical packaging. The company also delivers finished goods direct to sites across the globe.
With five qualified persons (QPs) on site, additional services include analytical and microbiological testing, technical consultancy, document review and auditing of suppliers.
Both the technical and regulatory release of investigational medicinal products (IMP) can also be performed by SCM Pharma, on behalf of its clients.
Clinical Quality Control
Complying with cGMP, SCM Pharma 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 clinical quality control systems. It is this quality service, plus its flexible and positive approach, that makes SCM Pharma stand apart from its competitors.
Demonstrating the company’s flexibility, batch sizes can be created to any scale as required, from one unit upwards. The company is also able to scale-up projects to meet commercial requirements. Depending on their needs, clients can elect to use SCM Pharma’s full range of professional project management services or select individual modules of the company’s capabilities.less
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