Developing micro QC for ATMPs

What are the top trends relating to sterility testing of ATMPs?

For me, one of the most promising developments involves the use of the next-generation sequencing-based sterility test (NGSST), which uses whole genome amplification and sequencing followed by microorganism identification with 48 hours.¹ This method removes the requirements for a culture period and has a higher accuracy than other rapid testing methods such as ATP bioluminescence.

Reverse transcription-polymerase chain reaction (RT-PCR) technology is already available for use with kit-based sterile release assays that can detect bacterial and fungal contamination within just several hours.

Sustainability is an ever-present consideration. The developments towards automation and the generation of more accurate and direct analytical methods that eliminate the need for extensive sample and assay preparation help reduce the volume of plastic consumables used to generate results.

Environmental concerns may also be addressed with the generation of recombinant proteins that have been developed to include all three of the enzymes involved in the LAL coagulation cascade, occurring in the presence of endotoxins, as a replacement for naturally sourced LAL reagents.² The recombinant proteins may present a solution to the harvesting of horseshoe crab blood cells which results in at least 130,000 horseshoe crabs being killed annually.³

Finally, although it has been several years now since regulators approved the use of nucleic acid amplification techniques (NAT) as a first line method for mycoplasma testing, having experienced the weeks of waiting for the classical compendial culture method to complete, this approval still feels revolutionary.