Session: Special Topic 4: PDA QbD Book and PDA Vaccine Development Lifecycle Technical Report

Live Q&A (ST4)

Wednesday, September 29, 2021

09:09 – 09:30 EDT

Quality by Design (QbD) is not a new concept in fact, the first thoughts on it date back to the 1950s, but it’s more typically associated with the FDA’s steps to include QbD concepts into cGMPs starting in 2002 and the publication of ICH Q8 in 2006. It places an emphasis on product and process understanding and process control based on sound science and quality risk management. Over the last eighteen months the true value of QbD in facilitating the rapid but effective development and safe deployment of quality vaccines to fight a global pandemic has been realized. This session will highlight specific applications of QbD in vaccine development with reference to the soon to be published PDA Technical Report, but also remind us of the value of investing in this type of approach more broadly within our industry as outlined in the PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, published in March 2021.

Moderator(s)

Valerie Whelan

Vice President, Quality
Thermo Fisher Scientific
Ballycoolin, Dublin, Ireland

Panelist(s)

Cristiana Campa, PhD

Technical R&D Advisor and Fellow
GlaxoSmithKline
Siena, Toscana, Italy
AK

Amin Khan, PhD

Chief Science Officer, Human Health
GreenLight Biosciences, Inc.
Medford, Massachusetts, United States
Sabrina Restrepo, PhD

Director, Global Vaccines Technical Operations
Merck & Co., Inc.
West Point, Pennsylvania, United States