Best practices for genetic characterization
and QC in cell line development
Recorded Tuesday 16 May 2023
Consider the following: your drug development program is nearing the finish line and you are about to get ready for clinical trials, when your team unexpectedly identifies a genetic sequence variant in your original master cell bank, leading to months of push back on filing your IND. We have unfortunately seen this too often happen with our customers... While pushing back the expected clinical trial readiness or contemplating switching up the candidate clone used might be your next course of action, one important question to mull over is whether this outcome could have been avoided altogether, had proper precautionary screening measures been put in place?
In this webinar, we have discussed:
- the various stages of the CLD process and where one could implement proper genetic QC steps.
- at each of these critical steps, we will go over some of the key challenges and considerations, provide the best genetic QC practices,
- the role that our TLA-based QC can play in facilitating early phase testing and minimizing time to clinic.
With a decade of experience supporting all leading drug manufacturers and CDMOs from clone selection down to their BLA filing, our experts adopt a phase-appropriate analytical testing approach to accompany you and your team towards regulatory compliance. Cergentis is therefore well-positioned to accelerate your path to commercialization by monitoring essential genetic quality parameters with a single, cost-effective assay.