Upstream processing 2023

Environmental monitoring: optimizing microbial control in cell & gene therapy workflows

Cell & Gene Therapy Insights 2023; 9(5), 539–547

DOI: 10.18609/cgti.2023.079

Published: 20 June 2023
Innovator Insight
Nico Chow

Microbial control within biopharmaceutical production is critical to help ensure drug products are free from viable microorganisms. Implementation of an effective environmental monitoring program is required as part of the good manufacturing practice (GMP) guidelines, where minimally, the program should require the microorganism identification at the species level, or genus level where appropriate. Although various techniques exist, genotypic identification is considered to be the industry standard for microbial identification, because a DNA sequence potentially offers an unambiguous result. In this article, the Applied Biosystems™ MicroSEQ™ Rapid Microbial Identification System, designed to support the recommended qualification guidelines by regulatory agencies worldwide, is discussed. Used by major pharmaceutical companies worldwide, the MicroSEQ Microbial Identification System is an end-to-end rapid genotypic sequencing solution based on ribosomal gene sequencing for bacterial and fungal species-level identification. The solution can generate accurate results in less than 5 hours.