The principles and practices of Quality by Design (QbD) for biopharmaceutical, biosimilar, and other biologic
manufacturing processes are here now, with regulatory authority expectation for market approval
submissions to include at a minimum the quality target product profile (QTPP), identification of critical
quality attributes (CQAs) and justification of critical process parameters (CPPs). The principles and practices
of QbD are applicable for both in-house and contracted-out biopharmaceutical development, manufacturing
Unfortunately, there is so much confusion today about what QbD is and isn’t: What is so different about
QbD? Must QbD include a thorough multi-variate analysis of design space? Does QbD guarantee regulatory
freedom to independently make future manufacturing process changes? Does QbD mean no future
Practical suggestions to help your company apply QbD to your biopharmaceutical, biosimilar or other
biologic development program will be provided by examining what has worked already for other companies.
The six (6) key steps of QbD will be examined and discussed carefully. Also, this course will identify
the limitations of the QbD approach.