NEWS
Melbourn launches fast track formulation and analysis service
An alternative approach to formulation and accelerated feasibility testing is being launched by contract research organisation Melbourn Scientific, which is well respected for its analytical services. For the first time companies will be able to access an integrated package of formulation, method development, analysis and short-run clinical manufacture from the fully independent CRO.
The Company has recently established a dedicated formulation facility to complement its analytical capacity and Business Development Director Mark Hammond explains the benefits:
"Most contract formulators tie this service with a specific device or IP 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."
Melbourn Scientific has recently enhanced its experienced team of formulators. David Ward, formerly of the Science and Technology Group of Bespak, and a number of his colleagues, have joined the company, bringing a wealth of knowledge of formulation around inhaled and nasal products.
The company has also invested in a bespoke suite of clean rooms to allow enhanced flexibility for formulation and clinical supplies manufacturing, as well as extending its lab facilities by over fifty per cent.
Accelerated feasibility projects are designed to expose any weaknesses in the formulation at an early stage. The idea is to anticipate the weak spots and set up challenges to eliminate them. Close cooperation between formulators and analysts as well as rapid analytical support of the formulation and manufacturing improves this process.
Melbourn has invested in specialist equipment to increase the performance of these services as well as streamlining workflows and processes in support roles. For example by investing into the latest Waters UPLC (Ultra Performance Liquid Chromatography) technology with its high throughput and low run times the output of many analysts can be run in a much shortened time frame, allowing team work to reduce project turnarounds to days rather than weeks.
Melbourn Scientific works with many of the major device developers, consultant companies, large pharmaceutical companies and a wide range of biotech and healthcare companies. This means that the company has significant experience of a wide variety of compounds from tablets, creams and patches through to nebulisers, PMDI, nasal sprays and dry powder inhalers as well as other delivery systems and is able to develop novel original formulations or work on re-formulation projects.
Where required, the company also offers lab scale manufacture under GMP.
As Mark concludes, “Our independence allows us to be objective in our recommendations and gives clients' confidence in the validity of our findings. Integrating formulation closely with analytical investigations allows manufacturing intelligence to be collected at all stages of the development process.”