May the (Power of the) Pool be with you: Accelerating time from DNA to GMP – STI based CLD Platform

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.

Join our cell line development expert Sebastian in this webinar and discover the Power of the Pool. Also, find out how:

non-clonal pools help unleash the full potential of therapeutic proteins right from the start.
an interweaving of several disciplines leads to optimal timelines and minimal risk during CMC development.
an STI (semi-targeted integration) based expression platform makes a seamless scale-up and cGMP transfer possible.

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Sebastian Schwamb

Senior Director Process Science Upstream, Rentschler Biopharma SE

Sebastian Schwamb is Senior Director of Process Science at CDMO Rentschler Biopharma. Since joining the company in 2020, he has overseen cell line development, genotypic characterization, and early-stage USP development.

With over 15 years of experience in cell line and upstream process development, Sebastian is a seasoned professional. His expertise extends beyond the CDMO sector, having worked in big pharma at Sanofi, small biotech at Ganymed Pharmaceuticals (a predecessor of BioNTech), and academia at TUM and Mannheim University of Applied Sciences in collaboration with Heidelberg University.

His passion lies in understanding and optimizing processes, from nurturing stable producer pools and cell lines to achieving scalable USP processes.

moderador

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.