Manufacturing Materials for Clinical Trials

ABSTRACT

CDMOs need to gauge their internal capacity of temperature storage units, form strategic partnerships with logistics companies, and potentially offer validated temperature storage of clinical trial material. Through the use of secure document sharing platforms, remote viewing systems, and virtual site tours, clients can be assured they will be able to perform a thorough review of facilities and quality systems and have connections with the subject matter experts and remote access to live action activities to meet their programme requirements and quality standards. To ensure projects continue to run to time, it is vital that upper management and business development have the ability to check in constantly. Hoerner (Purisys) Modelling and simulation tools have been extremely valuable to reduce the amount of work required for scale-up;for example, engineering technologies such as Scale-up Systems' Dynochem can model solvent swaps, drying, distillation, off-gassing, and many other fundamental elements of synthetic and chemical processes.