Four years ago, local entrepreneurs Fiona Cruickshank and Brian Dougherty, took a major leap of faith and invested £5m from their booming business The Specials Laboratory, to set up sister company, Specials Clinical Manufacturing.
Now, the Prudhoe-based business, which offers a wide range of small-medium scale manufacturing, development, filling, packaging, technical support, testing and quality services for its clients’ clinical trials and commercial needs, is going from strength-to-strength having won a number of lucrative contracts.
One such collaboration has seen Specials Clinical Manufacturing taking a key role in the development of a product that promises to revolutionise injectable drug delivery around the world. Working with Glide Pharma, Specials Clinical Manufacturing is helping to perfect a patented needle-free, solid dose injection technology known as the Glide SDI™.
The company was appointed to work on the process development and validation for the drug product which will eventually be adapted to a huge range of injectable products, encompassing small molecules and biologicals, including vaccines.
Work on the Glide SDITM, which promises to be much less invasive than traditional injection methods, has been ongoing since the company was formed in 2001, initially under the name of Caretek Medical.
“We’ve been working with Glide Pharma on several products,” says Brian Dougherty, chairman of Specials Clinical Manufacturing. “Some can be terminally sterilised while other more labile substances require an aseptic process using bespoke isolator equipment, which we are of course able to provide.
“Everyone has worked amazingly hard alongside the Glide Pharma development team to move things forward. One of the major challenges has been assembly of the drug cassettes for stability testing and clinical trials, a complex task that has to be completed, currently by hand. Of course, this process will be automated once manufacturing scale-up goes ahead.”
As well as addressing the fear of needles that affects more than 10 per cent of the population, the Glide SDITM offers a safe, convenient and easy-to-use alternative to traditional injections. With the potential to avoid refrigeration, the Glide SDITM is also easier and cheaper to transport and store. In addition, as the drug or vaccine is pushed into the skin, and not fired as with other needle-free technologies, the Glide SDITM ensures accurate, reproducible dosing.
The Glide SDITM is covered by a number of broad patent applications that have been filed in all major territories worldwide and the first of three of which have been granted in the UK. There has already been intense interest from a number of big-name pharmaceutical companies for a product that has the potential to reach hundreds of millions of patients.
One of the major factors behind Specials Clinical Manufacturing’s success, Brian cites is its staff: “We are attracting a wealth of talented individuals from across the world which is giving us a real advantage over our competitors. As well as that, our home grown talent is second to none, with our graduate recruitment and retention hitting an all time high. In fact, within the past few months we have taken on nearly a dozen new recruits of graduate level and above.”
Specials Clinical Manufacturing places a huge amount of emphasis on staff development and was last year presented with a National Training Award. Brian believes in open lines of communication with his staff and credits this approach with much of Specials’ success.
Brian added: “We try to make the business of science fun and have created a bright, creative and contemporary working environment for all staff. This no doubt contributes to the overall ambience of the office and the happiness and contentment of our staff, which of course is translated into the way we treat our customers.”
The company also takes an innovative approach to thought-leadership with managing director Fiona Cruickshank heavily involved in networking and speaking opportunities. Most recently, Fiona presented at NEPIC’s pharmaceutical networking event at the Stadium of Light, Sunderland and is a regular guest speaker for the Entrepreneur’s Forum.
With five Qualified Persons (QPs) available on site, Specials Clinical Manufacturing offers a full range of services including auditing of suppliers, production and testing facilities, document review and it can perform both the technical release and regulatory release of IMP (Investigational Medicinal Products) for its clients.
Based in a state-of-the-art custom built unit, the company occupies a 17,000 sq ft unit, including 10,000 sq ft of clean room facilities which offers both sterile and non-sterile manufacturing services, including ampoule, vial, ampoule and syringe filling (aseptic and terminally sterilised), cytotoxic formulations, cytostatic products and labelled patient packs. The facility has allowed the business to venture beyond clinical trial only work to facilitate clients on commercial and scale-up projects.
In addition to its manufacturing services, the company provides a wide range of packaging solutions such as blinded and unblinded labelled patient packs; blister packaging for pharmaceutical products and packaging for commercial purposes. The company can deliver finished goods direct to sites across the world.
To accompany its core offerings, Specials Clinical Manufacturing is now also offering its customers two highly technical and innovative services, radio-labelling and biologicals.
As the region’s healthcare and manufacturing sectors continue to flourish, Specials Clinical Manufacturing remains extremely proud of its North East roots and its association with NEPIC as it reaches new and exciting markets across the globe.
