Rethinking the Clone-First Paradigm for First-in-Human Biologics
A stable-pool strategy can move cell line development off the critical path to Phase I while preserving a path to a conventional clonal cell line as a program matures. The post Rethinking the Clone-First Paradigm for First-in-Human Biologics appeared first on GEN - Genetic Engineering and Biotechnology News .
The article discusses the potential benefits of adopting a more flexible approach to clone-first paradigms in first-in-human biologics development. Traditionally, the process involves creating an expression construct, transfecting host cells, isolating single cells, screening numerous clones, selecting a lead clone, establishing a cell bank, developing the process, and finally manufacturing clinical material.
However, the article suggests that for many first-in-human programs, the initial focus should be on producing a small quantity of well-characterized material rather than commercial manufacturing. This change in perspective could lead to a more efficient use of resources and time. The article also highlights the importance of controlling heterogeneity within the stable cell pool, as it can impact growth, productivity, stability, and product quality.
Transposase-based cell line development systems, such as the Leap-In Transposase platform, are mentioned as an alternative to conventional random integration, as they can generate stable pools with a narrower distribution of cellular characteristics.
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