One of the newest methods in the health sector is cell therapy in which living cells from a patient or healthy donor are used as a medicine to cure or to support the patient. These medicinal cell products, so called ‘Advanced Therapeutic Medicinal Products’ or ATMPs, have the potential to improve the lives of patients suffering from serious conditions where limited or no therapeutic options exist today. Nevertheless, one of biggest hurdles in the commercialization process is the investment needed to build or to access highly-specialized facilities needed for ATMP manufacturing according to current good manufacturing practices (GMP) guidelines. Moreover, ATMPs are living pharmaceuticals with a complex manufacturing and logistic process, which needs to be thoroughly optimized in a very early stage of the development.
Recently, we started the design and build of a GMP-certified cell therapy hub with the support of EFRO-Flanders and Flanders Innovation & Entrepreneurship (in Dutch: Agentschap Innoveren & Ondernemen; VLAIO). The mission of Anicells is to facilitate and accelerate the go-to-patient process for novel cell therapy products through providing guidance and support during the clinical development, as well as access to a GMP certified accelerator platform with integrated services, such as process optimization, regulatory and market access support. In collaboration with the sponsor of the ATMP, Anicells will drive the ATMP through the early clinical trials with the objective to generate a safe and effective ATMP.