Chinese Hamster Ovary (CHO) cells are the principal host used in the manufacturing of recombinant therapeutic proteins. To support this industry, NIST recently established the NISTCHO Reference Material (RM 8675), a living cell line intended to benchmark biomanufacturing processes. However, CHO cell lines are known for their genomic plasticity, where genetic drift, transgene instability, or chromosomal rearrangements can alter product quality or yield over time. Understanding this genomic evolution is essential for assuring the consistency of biomanufacturing.

The Applied Genetics Group is developing advanced measurement strategies to characterize the genomic stability of the NISTCHO cell line under various culture conditions. This research focuses on detecting genomic variation that occurs during long-term culture and manufacturing stress. Projects may involve using Next-Generation Sequencing (NGS) to map transgene integration sites and identify structural variants, and utilizing digital PCR (dPCR) for precise quantification of transgene copy number variations (CNV) and detection of low-frequency population heterogeneity. The goal is to establish a metrological framework that allows industry to differentiate between biological variability and measurement error in cell-based manufacturing.

Applicants with experience in molecular biology, mammalian cell culture, digital PCR, bioinformatics, or next-generation sequencing library preparation and analysis are encouraged to apply.

References:

Development and Characterization of the NISTCHO Reference Cell Line

Recommended nomenclature convention for the NISTCHO cell line and its product monoclonal antibody, cNISTmAb

biomanufacturing; bioreactor; genomics; NGS; next-generation sequencing; digital PCR; dPCR; CHO cells; metrology; molecular biology; gene expression; biologics; mAbs; monoclonal antibody; bioinformatics; biopharmaceuticals; genomic stability

citizenship

Open to U.S. citizens

level

Open to Postdoctoral applicants