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Interest Group Corner: Vaccines Interest Group

by Jane Halpern, Consultant, and Co-Leader, Vaccines Interest Group | Jan 28, 2019

Lifecycle Management a Key Topic for Vaccines

The Vaccines Interest Group met for a face-to-face meeting Sept. 25 at the 2018 PDA/FDA Joint Regulatory Conference to set an agenda for 2019 and discuss topics of interest to those in the vaccines community. Interest group co-leader Sabrina Restrepo, Director, Sterile and Validation Center of Excellence, Merck, opened the session with an overview of proposed activities for 2019. Following her talk, three speakers gave short presentations on topics pertinent to vaccine manufacturing.

Antu Dey, PhD, Senior Scientist, International AIDS Vaccine Initiative (IAVI) discussed the use of different platforms for vaccine production, focusing on examples for viral vector-based vaccines and recombinant protein vaccines. In their vaccine work, IAVI selects a specific cell substrate for suitability based upon the properties of the target vaccine antigen. Each cell substrate has technical and regulatory issues that must be addressed during product development and licensure. Next, Lindsay Morse, Associate Director, Engineering, Merck, discussed setting specifications and parameters for vaccines, focusing on approaches for changing process parameters and attributes over the lifecycle of the product. Morse noted that the long lifecycle of vaccines necessitates periodic changes to parameters and attributes, and that the development of standardized principles for legacy vaccines could be useful for the industry.

Restrepo then provided a short talk on vaccine lifecycle management with an emphasis on ensuring continuous supply. Changes to an approved product are driven by multiple reasons, including continuous improvement, capacity expansion, innovation and routine requirements. For a product used globally, these changes need to be reviewed by multiple regulators working under different regulatory systems. This can lead to an increase in the time from submission to approval.

The leaders of the V accines Interest Group encourage those interested in vaccine manufacturing to consider attending PDA’s inaugural Biopharmaceuticals Week in May. The interest group will also convene at the 2019 PDA Annual Meeting.

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