Biomedical Engineering Reference
In-Depth Information
4
USING A RISK ASSESSMENT
PROCESS TO DETERMINE
CRITICALITY OF PRODUCT
QUALITY ATTRIBUTES
Mark A. Schenerman, Milton J. Axley, Cynthia N. Oliver,
Kripa Ram, and Gail F. Wasserman
4.1 INTRODUCTION
This chapter describes a process for determining the criticality of quality attributes for
biotechnology-derived products. For these products, a phased implementation of the
Quality by Design (QbD) principles [1-3] may be suitable because of increased
complexity for the process and product compared to small drug molecules. As an
example, a semiquantitative approach to risk assessment and criticality determination of
product quality attributes is described here. The result of the criticality determination
guides the implementation of a suitable testing plan and appropriate process controls.
The result also facilitates development of a meaningful manufacturing process and
operational targets. As more knowledge of the process and product is gained during
clinical studies, a more comprehensive approach to QbD implementation, such as
establishment of design space or use of PAT, becomes more feasible.
Examples of criticality determinations are also presented for two product quality
attributes (glycosylation and deamidation) of anti-respiratory syncytial virus (RSV)
monoclonal antibodies.Theseexamples illustrate the typeofdata thatmight beconsidered
to support determination of criticality for product quality attributes, principally prior
product knowledge (laboratory, nonclinical, and clinical studies) and process capability.
