The contract research organisation (CRO) believes its offering can provide drugmakers with an alternative approach to formulation and accelerated feasibility testing for a range of drug delivery vehicles.
Melbourn has recently established a dedicated formulation facility to operate in conjunction with its analytical capacity, which has allowed it to offer this new service.
Mark Hammond, Melbourn’s business development director, said: "Most contract formulators tie this service with a specific device or intellectual property around the formulation, restricting the sponsor to a particular delivery mechanism.
“Our approach is to see formulation as an integral part of the product development process. By offering the services of our experienced formulators along with our existing battery of validation testing we can provide 'accelerated feasibility services' whatever the stage of the project."
Accelerated feasibility projects are intended to detect flaws in the formulations at an early stage of development. Once a weakness has been identified appropriate action is taken to eliminate it.
Melbourn claims that close cooperation between formulators and analysts, which is integral to its service, speeds up the process of detection and remedying.
Underpinning this is knowledge of a range of drug delivery systems, including tablets, patches, nebulisers and nasal sprays. The company’s knowledge of inhaled and nasal products was swelled recently with the recruitment of several people who previously worked at Bespak.
Melbourn believes its range of expertise will enable it to develop both original formulations and to re-formulate existing products.
Investment has also been made into the company’s infrastructure, extending its laboratory facilities by over 50 per cent. The new bespoke clean rooms have been built to provide flexible capacity for formulation and manufacturing.
Melbourn has also invested in Waters Acquity UPLC (ultra performance liquid chromatography) technology, which it believes will reduce project turn around to days rather than weeks.
Waters claims that one of its UPLC machines performs the work of three traditional high performance liquid chromatography (HPLC) systems.
The Acquity UPLC system uses Waters’ patented sub-2μm hybrid particle chemistry, which it claims offers significant advantages over the 5μm technology that is fitted in HPLC machines.
Waters’ system allows chromatographers to work at higher efficiencies with a much wider range of linear velocities, flow rates, and backpressures, according to the company.