ICH Q11 Development and Manufacture of Drug Substance
ICH Q11 Development and Manufacture of Drug Substance
Design Space Discussion for Biotech
■ The development and approval of a design space for some
biotechnology/biological drug substances can be challenging due to factors
including process variability and drug substance complexity (e.g., post-
translational modifications). These factors can affect residual risk (e.g.,
potential for unexpected changes to CQAs based on uncertainties related to
scale sensitivity) which remains after approval of the Design Space.
Depending on the level of residual risk, it may be appropriate for an
applicant to provide proposals on how movements within a Design Space
will be managed post approval. These proposals should indicate how
process knowledge, control strategy and characterisation methods can be
deployed to assess product quality following movement within the approved
design space.
ICI+
March 2012
Slide 23View entire presentation