Preconference Workshop: Implement Changes to Approved Biologic Drug Manufacturing and Controls Using Risk-Based Regulatory Approaches

Preconference Workshop Description: Changes are an inevitable part of drug product development and occur frequently even after licensure, when marketing approval has been received. For biologic drug products, such as recombinant proteins, vaccines, and novel modalities, these changes are not only critical for continual improvement of the manufacturing process and implementing advanced controls, but also have been seen by industry and regulatory agencies as a major risk and burden. Long multiple-year time frames for regulatory approval have driven the recent finalization of various guidance documents, such as ICH Q12, entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecyle Management, along with other global guidance documents and industry efforts.

These publications support the biologics drug manufacturing industry to maintain routine production, to improve product quality, and to enhance the efficiency and consistency of manufacture. Collaborations among drug manufacturers, regulators and third-party service providers over the years have built extensive knowledge to understand key factors of drug manufacturing correlated with risk. Against common assumptions, many of the manufacturing system and raw material changes that are typically considered major, could be categorized as moderate and minor changes. During this workshop, case studies based on selected collaborations will be presented, highlighting a science and risk-based approach to foster effective manufacturing changes and improvements. In addition, filing of a post-approval change management protocol (PACMP), also known as a comparability protocol in the U.S.A., will be reviewed for different scenarios.

By the end of this workshop, participants will further understand the procedures and criteria for the appropriate risk categorization and reporting of changes, along with the data required to enable national regulatory agencies to evaluate the potential impact of the change on the drug product quality, safety, and efficacy.

Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Breakfast for Preconference Workshop Attendees

8:30 – 9:15 AM: Welcome and Workshop Introduction

8:30 – 9:15 AM: Overview of Recent Post-Approval Change Regulatory Guidance -A Mindset Shift (Speaker: Janmeet Anant)

9:15 –10:00 AM: Using a Risk Category Approach aligned with regulatory notification and approval requirements (Speaker: Janmeet Anant)

10:00 –10:30 AM: Risk Factors Model Case Reviews (Speaker(s): Janmeet Anant & Kavita Aiyer)

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Attendees

11:00 AM – 12:00 NOON: Cell Banking Changes and their criticality to Biologics Manufacturing (Speaker: Kavita Aiyer)

12:00 – 12 :30 PM: Group Exerise (Speaker(s): Janmeet Anant & Kavita Aiyer)

12:30 – 1:30 PM: Lunch for Preconference Workshop Attendees

1:30 – 2:00 PM: Changes to the Cell Culture and Fermentation Process (Upstream) (Speaker: Kavita Aiyer)

2:00 – 2:30 PM: Changes to the Purification Process (Downstream) (Speaker: Kavita Aiyer)

2:30 –  3:00 PM: Changes to Analytical Procedures (Speaker: Janmeet Anant)

3:00 – 3:15 PM: Break for Preconference Workshop Attendees

3:15 – 4:00 PM: Roadmap to assess risk for any scenario & Tying it all together (Speaker(s): Janmeet Anant & Kavita Aiyer)

4:00 PM: All Preconference Workshops Adjourn for Day