Clarity in cell line development

Understanding the latest FDA guidance on investigational new drugs for cell and gene therapy

On the 28th January 2020 we saw the FDA update its guidance for industry regarding chemistry, manufacturing, and control (CMC) on the application of (INDs) for cell and gene therapy, including assurance of clonality and stable cell line development. Innovation driving gene therapy Within this document the FDA provides guidance to the industry and to …

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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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