Developing cell lines is a vital component of biopharmaceutical manufacturing. High productivity already at non-clonal pool stage, comparability of product quality between non-clonal pools & clonally derived cell lines and a robust & scalable USP platform process which is suitable for non-clonal pools and equally clonally derived cell lines, are crucial for reducing CMC timelines from the start of development to Drug Substance.
Today, we routinely utilize non-clonal pools to either evaluate lead molecule candidates (e.g. regarding expressability and product quality) or optimize expression vectors before starting CMC activities in so-called non-clonal pool based PoC studies. Beyond that, we deploy non-clonal pools in active programs for early material supply. Looking ahead, a future vision is to apply non-clonal pools up to GMP manufacturing for early clinical phases.
Watch this webinar with our cell line development expert Sebastian Schwamb, Senior Director Process Science Upstream, and discover the Power of the Pool. Also, find out how: