Clarity in cell line development

Clonal Derivation in Biopharmaceutical Cell Line Development – a Regulatory Perspective

19th November 2019: Early last month saw publication of the latest perspectives from the FDA in a paper entitled: Considering “clonality”: A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development authored by Joel Welch and Sarah Arden (USFDA). Key Points As a major supplier of technologies for …

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Proof of clonality and its importance in stable cell line development

What is clonality and why is it important Clonality is a crucial step in stable cell line development (CLD) for biotherapeutic workflows and one closely monitored by the medicines’ regulators. Their questions lead to two possible conclusions about how they view the importance of clonality1: Assurance of “clonality” of stable production cell lines is of …

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Continuous innovation of host cell lines for cell line development

Author: Ian Taylor, Chief Commercial Officer, Solentim At last week’s Oxford Global Conference in London, a couple of talks stood out for me on innovations for improving host cell lines in cell line development. First up was Mario Pereira from Horizon Discovery who nicely explained the history of the Company’s HD-BIOP3 GS null knockout for …

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Eliminating enrichment steps in cell line development – reduce cell screening from 5000 to 200 clones per project

Coffee Morning Chat with Ferenc Boldog (ATUM) and Ian Taylor (Solentim): An expert discussion on the evolution of cell line development to negate the need for enrichment In the time since my previous blog following the ESACT conference in May, in which I discussed fluorescence screening of clones in cell line development, I have been …

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A bright future ahead for cell line development in China

China has experienced rapid economic growth over the last ten years. Thanks to economic reforms in 1978, the country has experienced an explosion in productivity, capital investment and in the upskilling of its workforce[1]. Per capita GDP for each Chinese citizen has nearly tripled since 2008, according to a recent report[2], while college admissions have …

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