Confidence Beyond Compliance
During the drug development process, the batch sizes manufactured generally increase. The early stage clinical trials usually involve using a small dosing regime to a small number of subjects, saving the majority of the manufactured product for stability studies and analytical testing. As the development process progresses from formulation design to Phase I clinical trials and subsequently through to Phase II & III, batch sizes continue to increase. If the clinical trial outcome is positive, resulting in the granting of a marketing authorization, the batch sizes manufactured may continue to increase further to cover the market demands.
PharmaLex supports client to coordinate and communicate drug scale up with relevant authorities to stay compliant.