On the clock: a collaborative approach to advancing adoption of RMM

EPR’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry.

Traditional methods for assessing microbial contamination in pharmaceutical products can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. Eur. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph. Eur. 2.6.7). Given their short shelf-life, there is a need for methods that generate more rapid results for emerging advanced therapy medicinal products (ATMPs) such as cell and gene therapies. Currently, there are more than 2,000 active clinical trials for cell and gene therapies,1 with the market expected to grow from $8.6 billion in 2022 to $21.33 billion in 2026.2 Rapid methods are also necessary for compounded sterile preparations and positron emission tomographic (PET) products.3 Despite being available, rapid microbial methods (RMMs) have not been widely adopted. This is partly due to challenges facing manufacturers who need to independently validate RMMs.