Drug Product Development Capacity Doubles with Non-GMP Facility

Almac has announced the expansion of its drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at UK headquarters in Craigavon. The new facilities double the company’s current pharmaceutical development capacity 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 laboratory-scale experiments, with batch sizes ranging from <1 kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations, explained: “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.”

Almac Group, +44 2838 363363, tania.davis@almacgroup.com, www.almacgroup.com.