Almac doubles drug product development capacity with a new non-GMP facility

17-Jan-2013 - United Kingdom

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Almac announces the expansion of the drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at the UK headquarters in Craigavon.

Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations explains “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies which is why it was also important that we doubled our analytical capacity in parallel.”

https://www.bionity.com/en/news/141227/almac-doubles-drug-product-development-capacity-with-a-new-non-gmp-facility.html