Application note

Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method

Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.

Time-to result is an important attribute of testing for short shelf-life cellular therapeutics. As a result, growth-independent rapid assays are in increasing demand.

Learn from authors Jan-Niclas Luebbers, Dr Alexandra Mueller-Scholz and Dr Diana Patzelt from Sartorius as they compare the bacterial and fungal detection performance of the Microsart ATMP Bacteria and Microsart ATMP Fungi detection kits and the compendial method. They’ll summarise their results, findings and recommendations in this application note.

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