Tony Cundell, Ph.D.

Published Cundell, T. 2022 How the bacterium Cronobacter sakazakii precipitated a national shortage of infant formula Amer. Pharm. Rev. 25(5):10-16

Co-author of the PDA COVID-19 Pandemic Task Force article entitled "Control to Minimize Disruption of the Pharmaceutical Supply Chain during the COVID-19 Pandemic" published in the July/August 2020 issue of the PDA J. Pharm. Sci. & Technol.

Co-chair of the task force responsible for PDA Technical Report #57 on the exclusion of objectionable microorganisms from non-sterile drug products, medical devices and cosmetics was published October 23, 2014.

Former member of the 2020-2025 USP Microbiology Committee of Experts. Areas that I worked on include the revision of the dietary supplement chapters USP <2021>, <2022>, and <2023> and the development of a compendial rapid microbial contamination/sterility tests for short-lived cell-derived therapies, compounded sterile preparations, and radiopharmaceutical products.

Author of two book chapters Microbial Contamination Risk Assessment in Non-sterile Drug Product Manufacturing and Risk Mitigation and Exclusion of Objectionable Microorganisms in Non-sterile Pharmaceutical Drug Products Pharmaceutical Microbiological Quality Assurance and Control – A Practical Guide for Non-Sterile Manufacturing. D. Roesti and M. Goverde (editors) J. Wiley & Sons 2020

Member of the PDA Task Force on TBA/TCA Taints of Pharmaceutical Drug Products. A 95-page technical report was published in May, 2012 that emphasized risk mitigation. A summary article was published in the September 2012 issue of Pharmaceutical Technology.

In June, 2009 I was co-editor with Anthony Fontana of the definitive book "The application of water activity determination in the pharmaceutical industry" This book, USP <1112> and more recently <922> Water Activity have been influential in applying water activity measurement in the pharmaceutical industry

Chair of the PDA Task Force responsible for the publication of the ground-breaking 1990 Technical Report #33 The evaluation, validation and implementation of alternate microbiological methods

Specialties: Microbial contamination risk assessment; Application of water activity determination to the pharmaceutical industry; Rapid Microbial Methods; Sterile compounding; Probiotics; Microbial Identification; Microbial testing in stability programs Compendial activities

Tony Cundell, Ph.D.

Articles by Tony Cundell, Ph.D.

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