Clarity in cell line development

Assurance, Validation and Verification in Clonality

Duncan Borthwick PhD This document represents the opinions of Solentim Ltd and should not be used in place of regulations or published guidance from the USFDA or any other regulatory body Within the cell line development community there is a widely accepted regulatory expectation to demonstrate that a Master Cell Bank (MCB) has been derived …

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Webinar | Revolutionizing Cell Line Development Workflows with New Technology

Last week over 300 participants tuned in from 33 countries to hear experts in cell line development (CLD) discuss technology that could revolutionize their workflows. Mark Stockdale and Oren Beske, Amalgamators of Business and Biology at Solentim and ATUM respectively, discussed the essential pillars of cell line development, the practices revolutionizing workflow efficacy, and the …

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Rapid on-boarding of the VIPS platform helped provide a competitive edge for Biotech start-up and a successful IND outcome

As the pressures on cell line development (CLD) laboratories are ever-increasing to expand into the expression of new modalities, you need a cell line development workflow that seamlessly works from day one. Biotheus, a new innovator biotech company, wanted a to invest in instrumentation to support CLD activities that could provide the following key attributes: …

Read more Rapid on-boarding of the VIPS platform helped provide a competitive edge for Biotech start-up and a successful IND outcome

Podcast | Novel Methodologies for Rapid Vaccine Production

In this Podcast, Mark Stockdale and Duncan Borthwick discuss COVID-19 and developments in vaccine production methodologies with reference to a paper from GSK , “Integration of high-throughput analytics and cell imaging enables direct early productivity and product quality assessment during Chinese Hamster ovary cell line development for a complex multi-subunit vaccine antigen" which features the …

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GSK pioneer a single-step cloning strategy to generate novel recombinant sub unit vaccine candidates.

Currently we are living in unprecedented times with a global health threat from a novel respiratory disease that has spread within weeks.  We are trying to subvert a large percentage of the population succumbing to this virus through early detection and isolation strategy.  There is the potential need for a long-term treatment if variants of …

Read more GSK pioneer a single-step cloning strategy to generate novel recombinant sub unit vaccine candidates.

Podcast | Viral Production for Gene Therapy

In the latest edition of this Podcast series, Duncan Borthwick speaks to Mark Stockdale about the developing regulatory landscape around viral production for clinical gene therapy. Topics include transient and stable expression, HEK293 cells and the choice of the appropriate cells, moving from research to clinical environments and an optimistic quote from Nobel laureate Michael …

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