Quality by Design (QbD) for Biopharmaceuticals - A Practical Approach

Bethesda, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

The principles and practices of Quality by Design (QbD) for biopharmaceutical manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), critical quality attributes (CQAs) and critical process parameters (CPPs).

Unfortunately, there is so much confusion today about what QbD is and isn’t. What is so special about QbD? Does QbD guarantee regulatory freedom to make future manufacturing process changes? Does QbD mean no future manufacturing problems? Does QbD really pay off for recombinant protein or monoclonal antibody products? Does QbD make sense for genetically engineered viruses and/or genetically engineered cell medicines?

Before launching into QbD, biopharmaceutical manufacturers must first have a firm understanding of the unique challenges facing all biopharmaceuticals, and then a thorough understanding of the International Council on Harmonization (ICH) strategic guidances (Q8, Q9, Q10) for this enhanced approach.

Practical suggestions to help your company apply QbD to your recombinant protein, monoclonal antibody, biosimilar, or gene therapy 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.

Who Should Attend

This course is designed specifically for those involved in or interested in an enhanced control system for biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/QC, Regulatory Affairs, Manufacturing and Process Development personnel.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain the importance and underlying principles of an effective QbD approach for biopharmaceuticals
  • Apply the principles of QbD to all types of biopharmaceuticals – recombinant proteins, monoclonal antibodies, biosimilars, and gene therapy products
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States
John Geigert, Ph.D., RAC, President, BioPharmaceutical Quality Solutions