The Role of Microbiologists in Drug Product Development

Donald C. Singer; Deborah D. Gross; Anthony M. Cundell

doi:10.5731/pdajpst.2025-000010.1

Abstract

The role of the microbiologist during product development of medicines ensures patient safety during clinical trials and also the continuation of microbial control through commercialization of the new product. Microbiological expertise, insight, and cGMP input for new product development is needed for formulation, manufacturing, packaging and monitoring, plus testing of in-process materials, finished dosage form and stability. Risk assessment and evaluation of potential microbial contamination origin(s) support a phase-appropriate, broad end-to-end analytical approach to microbiological contamination control strategy. The ultimate beneficiary of this robust oversight and management of quality is the patient. Using knowledge and risk assessment along with experience (of non-sterile and sterile drug product development) provide for a balanced approach to microbiological quality in medicines. This paper will discuss more specific area detail to consider for the role of a microbiologist in non-sterile drug product development.

Received February 21, 2025.
Revision received May 3, 2025.
Revision received April 21, 2025.
Accepted May 6, 2025.

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