Isolation of aseptic processes is not a new technology. Flexible film isolation has been used in aseptic processing since the 1970s, but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface.
Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.
The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.
Cell and gene therapies have the potential to revolutionize incurable, debilitating, and often fatal diseases. This paper outlines eight emerging and novel uses for osmolality testing in advanced therapy production.
This paper explores the challenges of vaccine development and how they can be overcome by applying a quality by design (QbD) platform approach from early process development phases forward. The impact of the COVID-19 pandemic on vaccine production is evaluated, with insight on how flexible, integrated, closed-system processing is advancing the future of safe and efficacious vaccine production.