Adapting Drug Product Manufacturing Strategy and Processes for Pre-Sterilized, Ready-to- Use (RTU) Vials, Syringes & Cartridges
Josh Russell
AST, USA
: J Pharm Drug Deliv Res
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 mindset 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.
Biography
Josh Russell, the Life Sciences Product Manager at AST is a leading industry advocate for adaptive manufacturing strategies and technologies that address production and quality challenges faced within the biopharma industry. He has been a frequent speaker, author and contributor of technical articles discussing market trends of parenteral processing and discussing advanced aseptic processing technologies such as; pre-sterilized single-use disposables and containers, and robotic automation with isolator-barrier systems. As Product Manager, he works with AST’s engineering, process and controls experts, along with industry partners to provide solutions to aseptic manufacturing challenges. He holds a Bachelor of Science degree in Mechanical Engineering from Saint Martin’s University and has over ten years’ experience in drug substance and drug product manufacturing.
jrussell@ast-inc.com
