Biomedical Engineering Reference
In-Depth Information
8
VIRAL CLEARANCE: A STRATEGY
FOR QUALITY BY DESIGN AND
THE DESIGN SPACE
Gail Sofer and Jeffrey Carter
8.1 INTRODUCTION
Although the concepts of design space and Quality by Design (QbD) go back at least to
1992, efforts to promote their formal adoption in biopharmaceuticals are more recent [1].
In fact, ICH Q8 was finalized in 2005 and the Annex to ICH Q8 is in draft form. The rate
and extent to which the industry will ultimately adopt these principles are uncertain. The
QbD and design space concepts relate broadly to product quality, which comprises “the
suitability of either a drug substance or drug product for its intended use” [2]. Discussions
relating QbD and design space concepts to virus clearance unit operations are sparse in
the literature. This chapter aims to achieve two main purposes: explore benefits,
limitations, and issues of applying ICH Q8 principles to virus clearance in biopharma-
ceutical manufacturing, and specifically to constructing a virus clearance process design
space, and present a framework strategy for constructing a virus clearance design space.
8.2 CURRENT AND FUTURE APPROACHES TO VIRUS
CLEARANCE CHARACTERIZATION
Manufacturers who derive guidance from the ICH Q5 guidance on viral safety currently
take a multifaceted approach to ensure that they produce a product with an appropriate
