A: IT IS A VALID QUESTION, as the Dendreon example showed that building multiple centralized processing locations may add immediate high-capital investments and raise regulatory questions regarding needle-to-needle logistics. There is no one-size-fits-all answer. New process-facility systems may be used in a centralized mode first, and if required, could be separated and relocated as decentralized systems at a hospital or cancer treatment center processing unit. These systems are becoming more available as prefabricated cleanroom units, which allow the modification from a centralized system to a decentralized system and vice versa. These types of flexibilities are a key requirement for future therapeutic developments and maybe even for rapidly deployable patient-care response systems.
Maik is COO of G-CON Manufacturing and founder of BioProcess Resources. He has more than 25 years of experience.