Biomedical Engineering Reference
In-Depth Information
7
APPLICATIONS OF
DESIGN SPACE FOR
BIOPHARMACEUTICAL
PURIFICATION PROCESSES
Douglas J. Cecchini
7.1 INTRODUCTION
The goal of biopharmaceutical process development is a robust manufacturing process
that delivers consistent productivity and product quality. The evolution of process
understanding, however, does not end at the time of biological license application and
approval. Process understanding continues to evolve as manufacturing history grows,
particularly with the emergence of more sophisticated tools and approaches for statisti-
cally based multivariate process monitoring [1] and process analytical technologies
(PAT) [2, 3]. In the course of process monitoring, process limitations identified during
scale-up or opportunities to improve process consistency and productivity are likely to be
identified. The ICH Q8 guidance document [4] provides
an opportunity to demonstrate a higher degree of understanding of material
attributes, manufacturing processes and their controls. This scientific understand-
ing facilitates establishment of an expanded design space.
Design space in turn is defined as
...
the multidimensional combination and interaction of input variables (e.g.,
material attributes) and process parameters that have been demonstrated to provide
...
