Translation to Operational Practice
Accelerating Biopharmaceutical Development ABD
2013
3rd AccBio / QbD Proceedings
General Submissions
Oral
Salon CD
Coronado Island Mariott
Wednesday, February 27, 2013 - 8:00am to 9:40am
Co-chair(s)
Xu, Y., Novartis
Pettit, D., Amgen
Understanding how to apply QbD principles during the development and commercialization of protein therapeutics can be challenging and will be covered in this session. Examples of topics will include; how to customize investment in QbD from low demand to high demand products as well as during development & post-licensure, the appropriate mitigation efforts to reliably achieve known CQAs and how to integrate QbD into internal Quality Systems or management practices.