Microbial Investigations: A New Paradigm from the PDA

Lessons learned about the value of microbial investigations from a virtual panel hosted by the European Pharmaceutical Review (EPR) and Charles River Microbial Solutions

The pharmaceutical industry has new important requirements to consider when dealing with microbial investigations. The Parental Drug Association (PDA) published Technical Report N. 88 in January 2022 and we had the opportunity to have subject matter experts Vanessa Figueroa, Jon Kallay and Jordi Iglesias discuss key aspects of microbial investigations recently to help people from the industry understand and implement this new paradigm.

Vanessa Figueroa, Founder & Chief Executive Microbiologist at VVF Science and co-author of the technical report, with more than 17 years combined experience in the life science industry, opened this informative presentation explaining how the idea of this new paradigm came to life and its two-phased approach: Phase 1 for Laboratory and Phase 2 for Manufacturing. Vanessa highlighted the main points to consider when approaching these two phases, taking into account all the key aspects of TR88, from the roles and responsibilities of the microbiologist and alignment on nomenclature and definitions to the root cause analysis tools for microbiology.

Jon Kallay, Senior Technical & Market Development Manager for Charles River Laboratories, presented the first case study of this virtual panel. He used as an example a manufacturing site for a biologics product that delayed production for months due to ongoing water contamination issues, highlighting both the human errors and the corrective actions implemented to get the production back on track.

The second case study, presented by Vanessa Figueroa, focused on an environmental mold event for a non-sterile drug product. She provided an overview of all the factors that contribute to non-sterile product bioburden and how to adjust the investigational approach accordingly to implement the right corrective and preventive actions. Also, Vanessa underlined the importance of using the right verbiage when referring to EM investigation: i.e., using OOL (Out of Level, preferred to Out of Limit) instead of OOS.

The third and last case study, presented by Jordi Iglesias, Technology & Market Development Manager for Charles River Laboratories, featured a bacterial endotoxin failure for a parenteral product. Jordi explained the root cause, and the corrective and preventive actions for this study, emphasizing the importance of looking at deviations as an opportunity to learn and improve our processes.

The last part of the virtual panel was a round table, where our experts shared the trials and tribulations they experienced while investigating these microbial events in the real world, accentuating that addressing the true root cause is not always easy or straightforward.

The participants were extremely interested in these hot topics; most of them work with sterile injectables, non-sterile solids and liquids, and understand the biggest microbial challenges can be Environmental Monitoring (EM), Utilities Monitoring and In-Process Bioburden, among others.

This virtual panel on this topic proved relevant to the industry as hundreds registered and participated. The aim was to help microbiologists integrate the technical report easier and more effectively by enhancing their understanding of this new guidance and how to find information as it pertains to their process or method.

In case you missed this informative and educational event, don’t worry, you can still watch the recording here.

Chiara Ocone is a Strategic Marketing Specialist for Charles River's Microbial Solutions business.