Single-use, disposable technology could boost vaccine creation
The past decade has seen an explosion in interest of using single-use and disposable technologies for a variety of biological products, including MCMs. The interest is being driven, at least in part, by an increasing availability of new materials and components. Drug developers and researchers have been able to use the materials to explore previously closed avenues and have established a case for their continued use, according to PharmPro.com.
"With these levels of performance the types of options for manufacturing strategy both multiply and increase the potential for a paradigm shift away from conventional approaches," Dr. Nigel Smart said, PharmPro.com reports. "In terms of operating costs, using single use disposable technological solutions similarly offers some potential for a reduction in operating costs when it comes to manufacturing both clinical and commercial batches of material."
Among the benefits of single-use and disposable technologies are the opportunity they provide for reduced lead times, the support of rapid start-ups, immediate surge capacity, rapid changeover in strain and cell lines, reduced risk of contamination, reduction in hazardous waste and the creation of simpler methodologies.
Robert House, the president of Dynport Vaccine Company, said that such technology has potential for the manufacture of MCMs for unknown threats.
"Currently the National Strategic Stockpile is amassing many countermeasures for unknown or identified threats but in a case where infrastructure is damaged in some way and conventional systems are unavailable then some limited production of agents for a localized deployment could be made using this type of approach in portable production factories," Dr. Smart said, PharmPro.com reports. "The advantages then would be logistical since this would enable one to turn on and initiate production quickly, to reload quickly, and changeover campaigns for different threats. For this application, Dr. House believes single use disposable systems are value-added in terms of providing a solution."