Although dedicated to non-GMP development, the facilities will employ all of the company’s technical capabilities of its 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. 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, vice president of Technical Operations, said, “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.”