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news.Almac Group has created a new non-GMP formulation development facility and two new analytical laboratories in Craigavon, UK, to expand its drug product pharmaceutical development services.
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The new facilities will double the current pharmaceutical development capacity.
The new non-GMP formulation development facility will provide clients with greater flexibility and speed in formulation and process development, focusing on lab-scale experiments with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.
The development work will be then progressed and transferred to the GMP environment at an appropriate stage, which includes high levels of control over environmental conditions, claims the company.
Almac Group technical operations VP John McQuaid said the company is focused to ensure that it has 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," McQuaid added.
"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."