12 July 2008
At this year’s ICSE, UK-based Specials Clinical Manufacturing will be unveiling two new services that it expects will be viewed positively by the global pharmaceutical, bio and healthcare sectors.
Specials Clinical Manufacturing offers a wide range of small-medium scale development, manufacturing, filling, packaging, technical support, testing and quality services providing outsourced solutions for its clients’ clinical trial and commercial needs. Its portfolio of services is now being enhanced following MHRA approval for filling radio-labelled and biological products.
Radio-labelling
As the name suggests, radio-labelling relates to the attachment of a radioactive portion (typically carbon 14) to a drug molecule and then using a specialised camera, tracks its distribution throughout the body. This can be extremely beneficial to reducing the drug development cycle as both cost and lead time are shortened by identifying early on in the development of a drug molecule where in the body it is prone to act and therefore the likely effects. Given current industry trends and the rising costs associated with developing new drugs as well as fewer new drugs coming through to launch, Specials Clinical Manufacturing recognises that this is an area where it can add true customer benefit.
The technique can also be used later in the development process for example, to check it is reaching the intended organs in the body and that it is not accumulating somewhere where it could cause harm. This again can help to eliminate potentially harmful drugs at an earlier stage of development and reduce expenditure on unsuitable drug candidates.
Specials Clinical Manufacturing is targeting its new radio-labelling service to assist companies at both pre-clinical and clinical stages of development. The company’s exceptionally high quality standards will no doubt provide an ideal contract solution for those looking to outsource this element of their project.
Biologicals
The changing face of the pharmaceutical industry is seeing more of a shift to biological products as traditional small molecule “block buster” drugs are becoming harder to identify particularly as our level of understanding of how our drugs work at a molecular level within our bodies, increases.
Biological molecules by their nature, will typically require aseptic filling as they are not able to withstand traditional heat sterilisation. Specials Clinical Manufacturing has installed the capability to carry out aseptic filling using isolator technology and has been granted a biologics license that will no doubt benefit numerous customers.
This new license will complement the company’s vision to offer a range of technically challenging contract services to the biopharmaceutical and pharmaceutical sectors.
Commenting, Brian Dougherty chairman of Specials Clinical Manufacturing, said: “The introduction of both new services will help firmly 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.
“We are using ICSE to herald our new enterprises as we feel it is the ideal platform to showcase the company to many of our existing clients and prospects.”
Current services
Based in a state-of-the-art facility, Specials Clinical Manufacturing 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.
Specials Clinical Manufacturing 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.
With five Qualified Persons (QPs) available on site, the company offers a full range of services including auditing of suppliers, production and testing facilities, document review and can perform both the technical release and regulatory release of IMP (Investigational Medicinal Products) for its clients.
The company’s packaging services include blinded and unblinded labelled patient packs; blister packaging for pharmaceutical products and packaging for commercial purposes. Finished goods can also be delivered direct to sites across the world.
Quality is the bedrock of the business and as such, Specials Clinical Manufacturing aims to provide the right quality products in an agreed timeframe that meets its clients’ needs. Complying with cGMP, all work is closely monitored for quality performance and its highly trained and motivated staff work within stringent quality control systems.
The company’s approachable, flexible and positive approach makes it stand apart from its competitors and as such, it endeavours to work with clients to fulfil their requirements.
The launch of biologicals and radio-labelling filling marks the start of an exciting era for Specials Clinical Manufacturing and its clients and could result in the availability of completely novel drugs for the future.
Take the opportunity to meet the Specials team at ICSE Hall 4.1 stand 41B68 to find out more. Alternatively, pre-arrange a meet
