The Specials Laboratory, based in Northumberland, is to specialise in the supply of non-sterile products for use in small-scale clinical studies direct to hospitals after the specialist firm was licensed for the manufacture of investigational medicinal products (IMPs).
The new IMP service will assist clinical trial pharmacists and technicians, university medical schools and research doctors.
Operating from three MHRA-approved facilities, the company complies with current Good Manufacturing Practice (cGMP) and provides in-house Quality Person (QP) release, which will ensure products delivered to hospitals will be made to the highest possible quality standards.
‘Our quality-led manufacturing heritage allows us to produce virtually any non-sterile dosage form,’ said Robert Sludden, Quality and Technical Services Manager at The Specials Laboratory.
‘The company is also able to offer customers an experienced technical team that includes several pharmacists, senior pharmacy technicians and QPs – many with an extensive NHS background.’
With more hospitals opting to subcontract their IMP manufacturing needs, The Specials Laboratory is looking to build relationships with relevant NHS departments by offering to be their outsourced manufacturing partner supplying products for smaller clinical trials.
‘Hospital departments will be able to source a wide range of products from The Specials Laboratory for their IMP manufacturing requirements, including oral liquids, capsules, sachets, ointments, creams, ear and nasal drops, enema solutions, suppositories and pessaries,' added Sludden.
Set-up over a decade ago, The Specials Laboratory employs around 130 people and is a leading UK manufacturer of unlicensed medicines, which are bespoke for individual patients and supplied to community and hospital pharmacists and doctors.
