The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.