After a successful audit by the UK MHRA, Melbourn Scientific has been issued a manufacturing license and now has the capability to manufacture OINDPs for use in Phase 1 and 2 clinical trials, according to the company’s Director of Quality Carol Barbour. Melbourn already offers a range of analytical, inhaler testing, and formulation development services.
“A ‘one-stop’ approach to early drug development will benefit clients who want to accelerate new product and device advances,” says Barbour. “Our analytical approach allows us to troubleshoot and address issues early on. This will provide a high degree of confidence in the final formulation. It will also be welcomed by large pharma clients who need routine testing and a fast turnaround.”
“Although early research does not need to be performed in accordance with GMP, having development work performed by a GMP accredited laboratory gives confidence in the results. Following established protocols also helps to facilitate any due diligence processes if IP is being shared with external partners and can potentially increase the value placed on this data.”
