Almac has created a new non-GMP formulation development facility and two new analytical laboratories at their U.K. headquarters in Craigavon to expand its drug product pharmaceutical development services. The firm says that the new facilities double their current pharmaceutical development capacity.
The new non-GMP formulation development facility, according to Almac, will offer clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be dedicated to non-GMP work, the company says it mirrors all the technical capabilities of its existing GMP pharmaceutical development facility including control over environmental conditions as well as extending current capabilities in processing compounds with low OELs.
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 <1 kg up to an expected maximum of 15 kg scale for most technologies.
“Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities,” John McQuaid, vp of technical operations, explained. “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.”
This is not the only area where Almac has been expanding—the company have also been upgrading their API manufacturing facility at Craigavon, which they announced in October would be operational by the end of the year. This upgrade includes the installation of two 1,000 L reactors and a pressure filter dryer, which should allow production of GMP Active Pharmaceutical Ingredients (API) up to 150 kg batch size. It also acquired a Noack N 623 blister packaging line from Romaco back in October as part of an effort to expand its U.K. commercial packaging facility.