Global service provider Almac has expanded its drug product pharmaceutical development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at its U.K. headquarters in Craigavon.
The new facilities double the company’s current pharmaceutical development capacity, allowing it to meet the growing demand for its services, both from existing and new clients. The new non-GMP formulation development facility offers 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, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent 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 <1kg up to an expected maximum of 15kg scale for most technologies.
“Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities,” said John McQuaid, vice president of technical operations, Almac. “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.”