Biomedical Engineering Reference
In-Depth Information
Specifications
Process ranges
QbD
PAT
Design space
Sensors
LC/spec
CQA
DOE
Clinical exp
Preclinical data
SAR
Stability
Figure
1.3. The various elements of QbD. The boxes in the bottom row show all the relevant
information that is used todevelop the critical quality attributes. TheCQAandDOEdataare then
used to develop the design space. The design space and PAT tools help establish QbD.
1.7 CONCLUSIONS
Figure 1.3 depicts the various components of QbD discussed above and the correlation
between the various components. As shown in the figure, the outcome of the QbD
exercise is the establishment of the design space for the process and the operating
ranges (ORs) that help achieve the desired product quality. As mentioned earlier, the
reader is referred to the various sections of the topic to gain further understanding of the
various aspects of QbD. The editors hope that this topic will help establish a good
framework for any researcher to build Quality by Design into a manufacturing process
for a biomolecule.
REFERENCES
[1] PAT Guidance for Industry: A Framework for Innovative Pharmaceutical Development,
Manufacturing and Quality Assurance. U.S. Department of Health and Human Services,
Food and Drug Administration (FDA), Center for Drug Evaluation and Research
(CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA),
September 2004.
[2] Guidance for Industry: Q8 Pharmaceutical Development. U.S. Department of Health and
Human Service, Food and Drug Administration (FDA), May 2006.
[3] Kozlowski S, Swann P. Current and future issues in the manufacturing and development of
monoclonal antibodies. Adv Drug Deliv Rev 2006;58:707-722.
[4] Rathore AS, Winkle H. Quality by Design for Pharmaceuticals: Regulatary Perspective and
Approach. Nature Biotechnology 2009;27:26-34.
[5] Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Int
2007;36-40.
