April 24, 2024
Sponsored by MilliporeSigma
The genetic stability testing package for biopharmaceutical cell banks has remained relatively unchanged for decades. This traditional approach to genetic stability testing relies on a complex set of assays to meet ICH Q5B requirements, many of which have limitations in discovery power and sensitivity and require long timelines for completion.
Advancements in sequencing technology and applied bioinformatics have made whole genome sequencing a serious contender in routine biosafety testing and cell line characterization.
This technical note describes how the Aptegra™ CHO genetic stability assay, which is fully validated to GMP quality standards, is a faster, more accurate, all-in-one solution to traditional methods of testing. Information previously obtained from up to five different methods can now be analyzed using a single assay that provides:
Gene of interest (GOI) sequence analysis
Copy number determination validated for precision, accuracy, linearity, and range
Sequence analysis of flanking regions
Integration site determination
Analysis of insertions or deletions
The Aptegra™ platform leverages the depth of coverage of whole genome sequencing and combines it with robust bioinformatic programming to produce one seamless workflow yielding a comprehensive genetic stability snapshot in a single report.
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