Gene and cell therapy workflows frequently utilise HEK293/293T cells in the production of viral vectors. As was described in the 2020 FDA guidance on CMC and INDs for cell and gene therapy, both regulators and manufacturers alike are looking to standardize best practices around viral vector production workflows (1). With a keen eye on patient safety, avoiding the use of animal-derived reagents and using assurance of clonality as part of production quality control was highlighted . We evaluated two technologies, both already well accepted in CHO-based cell line development workflows, for their suitability with HEK cells. These technologies were the Verified In-situ Plate Seeding (VIPS) instrument, a high efficiency, single-cell seeder providing image-based regulatory assurance, and an animal-free cell growth supplement, InstiGRO HEK designed to support early single-cell growth, both commercially available from Advanced Instruments.
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