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Quality by Design—Case Study Vaccines| © 2010 PRTM Proprietary CONFIDENTIAL | 1 Quality by Design – Vaccine Case Study Last year, the CMC-Biotech Working Group (CMC_BWG) completed a case study to exemplify the application of Quality by Design to biopharmaceutical development “A-Mab Case Study” was well received & has served as a substrate to open up the dialogue between industry and regulatory agencies on the challenges of implementing QbD for biotech products Following on this success, facilitators from CMC-BWG have been approached to pull together a similar industry consortium (CMC-VWG) to promote QbD for vaccines Proposed Timeline Contact Vaccine manufacturersJuly 2010 Contact Regulatory AgenciesJuly –August 2010 Set-up NDAs and AgreementsComplete by Sep 15 th Kick- OffOctober 1 st
Quality by Design—Case Study Vaccines| © 2010 PRTM Proprietary CONFIDENTIAL | 2 A Vaccine QbD Case Study: What Is It? Word document co-authored by a consortium of company representatives to promote the implementation of ICH QbD guidelines in vaccine development Will be made available to the public Focus on science and risk-based applications Forward looking—focused on what individuals would like to do in the future versus what they currently do now Multiple perspectives offered as a result of the cross-company and cross-functional interactions Regulators (FDA, PMDA, EMA principals) will be invited to contribute to the case study, but not to endorse it Their insight into QbD application to vaccines would add immensely to its value Targeting top Vaccine Manufacturers To keep the group manageable, the first six companies to sign up by the September 1st deadline will be accepted into the program The Case Study is not… A mock CMC submission or a “Gold Standard” for how things should be done Attempt to receive an endorsement from the regulatory agencies An initiative that requires companies to share intellectual property—specific process operations, real results, etc. The Case Study is not… A mock CMC submission or a “Gold Standard” for how things should be done Attempt to receive an endorsement from the regulatory agencies An initiative that requires companies to share intellectual property—specific process operations, real results, etc.
Quality by Design—Case Study Vaccines| © 2010 PRTM Proprietary CONFIDENTIAL | 3 Contacts Sam Venugopal Principal T F M Castro Street Suite 400 Mountain View, CA U.S.A. John Berridge Pharmaceutical Ccnsultant T Bracklyn, St. Clare Road Walmer Deal CT14 7QB
Workshop Session 3 Questions 1 How would a control strategy look different in a traditional submission vs a QbD submission? How would parameters that are.
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