Doug Hausner, senior manager, continuous manufacturing business development, Pharma Services, Thermo Fisher Scientific, said such hurdles, among others, makes partnering with established vendors or CDMOs particularly important as the business case and associated timelines for the continuous manufacturing platform often will not work for a single product, and the decision to adopt the technology should be made early on or more broadly.
Continuous manufacturing (CM), whether it be for small or large molecule, provides a number of advantages to the drug developer/manufacturer, he commented.
“The benefits of quality, speed of development, and cost of goods sold are shared between a contract development and manufacturing organization (CDMO) and their customer.
“Once adopted, CM is a faster pathway from development to clinical and onto commercial since the traditional aspects of scale-up are removed.
“Additionally, the nature of continuous processes enables real-time quality monitoring in almost all cases, which often can be extended to real-time release. These factors combined provide for an agile approach to new product introduction,” he told this publication.
Still, noted Hausner, given that CM produces the same product as the traditional batch process, adoption can be slow, and users have the option of waiting until the process technology is fully commercially ready.
“Much of the commercial readiness for this type of technology is related to the interconnectivity of the units making up the manufacturing train.
“There is a need for control software that oversees the entire process train and communicates between the comprising components utilizing process information, which is being collected and processed in real-time.”