Josh Russell
AST, USA
Title: Adapting Drug Product Manufacturing Strategy and Processes for Pre-Sterilized, Ready-to- Use (RTU) Vials, Syringes & Cartridges
Biography
Biography: Josh Russell
Abstract
With the biopharma industry focus on producing biologic and protein based therapies the manufacturing paradigm is requiring a shift from dedicated high volume manufacturing strategy to one that requires flexibility to produce low volumes of high value products in multiple delivery systems. Technologies are emerging that provide not only a high degree of flexibility, but also provide a foundational manufacturing template that can be leveraged to reduce cost and risk. One of the key enabling technologies is the more recent introduction of ready-to-use vials and cartridges, which compliment well established pre-filled syringes options, allows manufacturers to adapt their current manufacturing mind-set to one that is more affordable and responsive to current and future pipelines. This presentation will discuss the key market trends associated with the manufacture of biotherapies, automated aseptic processing of pre-sterilized ready-to-use (RTU) containers (e.g. vials, syringes, and cartridges) on a modular manufacturing platform for these products, and experiential based recommendations for implementation of RTU formats in aseptic processes.
