INTEGRATING ANALYSIS WITH PROCESS CONTROL FOR CONTINUOUS BIOPROCESSING: EXTENDING THE LIFECYCLE CONCEPT TO PROCESS ANALYTICAL TECHNOLOGIES.

摘要

The most notable trends in the use of PAT tools in bioprocessing nowadays are: (1) the combined use of multiple tools to a product & process and (2) that information fusion provides a better process estimation and product quality knowledge foundation than the use classical use of one analytical method The lifecycle management aspects of validation launched by FDA in its 2011 Validation Guidance, arrived -through ICH Q11 (2012) and the forth coming ICH Q12 (2017), to all aspects of development, qualification and commercial manufacturing of large molecule drug substances. For continuous bioprocessing that challenges are significantly different and more complex than for batch processing of small molecules.