January 27, 2012: Almac’s Sciences Business Unit has completed MHRA inspections at its Craigavon headquarters in Northern Ireland and at its Elvingston, Scotland site. The inspections were the first biennial audits to confirm continued compliance with Investigation Medicinal Products (IMP) licences and GMP certificates.
The first inspection audited the company’s isotope chemistry facility in support of the IMP licence. The inspection included tours of the new manufacturing finishing suite and associated infrastructure in support of the company’s extended API facility.
Following the MHRA’s acceptance of Almac’s response report, the company’s licence will be applicable to both radiolabelled and non-labelled IMPs.
The second inspection covered the analytical laboratory in Elvingston, Scotland, supporting its GMP certificate as a contract analytical facility. As a result of the audit, two GMP certificates will be issued for human and veterinary applications.
Almac’s Sciences Business Unit recently announced a collaboration with MGB Biopharma in which Almac will manufacture MGB’s lead gram positive antibacterial compound MGB-BP3. The compound is a DNA minor groove binder and is currently in preclinical development with IND filing targeted for Q3 2012.
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