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Potency Assays, Aging Facilities Prove Twin Challenges for Vaccine Manufacturers

by Rebecca Stauffer, PDA | Nov 06, 2017

The challenge of using the right potency assays and the regulatory issues of aging facilities served as focal points of discussion at the Vaccines Interest Group meeting, Sept. 11, at the 2017 PDA/FDA Joint Regulatory Conference.

Interest group meeting leaders, Jane Halpern, PhD, Health Specialist, Vaccine Translational Research Branch, Vaccine Research Program, DAIDS, NIAID, U.S. National Institutes of Health, and Sara Gagneten, PhD, Associate Director for Regulatory Policy, Division of Viral Products, CBER, U.S. FDA, headed off the discussion on potency assays. A common challenge for all animal-based vaccines is variability. This often becomes apparent during the transition from in vivo to in vitro testing. Sometimes manufacturers accumulate data from clinical studies conducted for different purposes; this additional data may be used to correlate animal tests with human tests.

While Gagneten conceded that FDA continues to conduct research tests on potency assays, she cautioned that the Agency does not view itself as being able to impose specific potency tests.

Following the discussion on potency assays. Michael Schwartz, Director, Global Regulatory Affairs, GSK Vaccines, and Linda Kramer, Director, Global Regulatory Affairs, Establishments, GSK Vaccines, gave a short presentation on regulatory and compliance issues facing aging facilities. The main concerns, according to Kramer, are the potential for contamination, inspection issues, potential for drug shortages and the impact of modernization (recapitalization, time, product holds and process validation).

Vaccine manufacturers faced with an aging facility will have to make some hard decisions regarding modernization, Kramer further explained. If a manufacturer decides to outsource some or all of the process to a CMO, quality agreements come into play. If the manufacturer chooses to modernize the facility, the process may even need to be changed. And if the manufacturer chooses to build a new site filled with modern equipment, “that’s going to take time, money and validation.”

Naturally, any modernization plan will require involvement with FDA. Kramer recommends going to FDA with a well-thought-out modernization plan outlining defined expectations for the discussion.

Anyone interested in getting involved with the Vaccines Interest Group is encouraged to contact PDA.