New facility for Specials Clinical Manufacturing

In 2005 The Specials Laboratory invested £2m in a new arm of the business Specials Clinical Manufacturing offering a full range of final product manufacturing, filling and packing services for the clinical trials market.

The company has since won its first major contract with a product destined for the US.

'Up until now, we have been doing analytical work, packaging and distribution of clinical material. It has been mainly for small clinical research organisations, start-up pharmaceutical and biotech companies. This is the first large-scale manufacture of clinical material for a major pharmaceutical client. We are in talks with UK-based consultants about potential outsourcing of manufacturing for European and US clients on a similar scale,' says Cruikshank.

As a new build the company was able to design the clinical manufacturing area to the highest standards. The facility, located close to its exitsing Prudhoe site, is built around a suite of Class 10,000 cleanrooms, with a 5m2 room in the centre. The services offered at the facility include the filling of capsules, liquids, creams, ointments, as well as handling of potent materials, carrying out aseptic filling and producing terminally-sterilised products.

According to Dougherty, the company is 'quite comfortable' handling 50kg or 50 litre batches. It also has a form, fill and seal machine which it would like to put to use, and is equipped to freeze-dry biologicals.

The company is looking to move into small volume sterile production, and with the recent introduction of the Good Manufacturing Practices Annex 13 requirement for clinical trial materials to be produced by licensed premises, alongside the growing trend for outsourcing by many of the smaller seed companies, it expects business in specials clinical manufacturing to grow.

'Ultimately, we would like to see the clinical side of the business overtaking what they currently do in specials,' says Dougherty.

The pressure for pharmaceutical companies to produce children's medicines could also be an important factor for the company in the future.

'The [children's] work we do now will stand us in good stead when clinical trials on children's medicines do come through,' says Dougherty.