Microbial enumeration tests

Quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions in non-sterile products

Therapeutic Modalities:

Biologics, Cell & Gene Therapies, Small Molecules

Development Phases:

Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial

Quality Standard:

ISO 11737, GMP

Pharmacopoeia:

EP 2.6.12, USP <61>, EP 2.6.13, USP <62>