Biomedical Engineering Reference
In-Depth Information
5
CASE STUDY ON DEFINITION
OF PROCESS DESIGN SPACE
FOR A MICROBIAL
FERMENTATION STEP
Pim van Hoek, Jean Harms, Xiangyang Wang, and
Anurag S. Rathore
5.1 INTRODUCTION
The concept of “design space” has received a lot of attention in the biotech community
[1]. It is defined in the “ICH Q8 Pharmaceutical Development” guideline as “The
multidimensional combination and interaction of input variables (for example, material
attributes) and process parameters that have been demonstrated to provide assurance of
quality.” The guideline describes best practices for pharmaceutical product development
and emphasizes building quality into products by design, that is, designing processes
with a low level of risk for failure to achieve the desired product quality attributes. This
scientific approach to meet specific objectives, also known as the “Quality by Design”
concept, encourages demonstration of a higher degree of understanding of the
manufacturing process. This results in robust processes with better controls and less
variability and greater confidence of assurance of quality, which translates into increased
flexibilities in manufacturing and regulatory oversight [2]. The latter is elucidated in the
following excerpt from the guideline: “Working within the design space is not considered
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