Cell Line Development TestingChris Hebel2019-03-29T15:59:51+00:00
Cell line characterization is the first step in the development of a cell bank that produces a biopharmaceutical. The characterization of each cell line allows the best candidates to be screened for further development. This characterization typically includes some phenotypic and genotypic identity testing.
We have designed several amplicon sequencing assays to help the client confirm whether mutations exist in their prepared cell lines. Two-step limited cycle PCR is followed by paired-end next-gen sequencing.
Traditionally, Southern blot analysis is the method of choice to satisfy FDA’s requirements of charactering cell line genetic stability. Avance Biosciences is now offering two NGS approaches to analyze the transgene insertion sites.
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