Safety assays for quality control of ATMPs: improved mycoplasma detection for cell-based biotherapeutics

Jens Björkman, Andreas Hecker

30 April 2025

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Manufacturing Quality Control for Plasmid DNA Critical Starting Materials

A Frazer, L R. Salvitti, S Lovatt et al

29 April 2025

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Next-generation sequencing in adventitious agent testing: navigating regulatory acceptance

Olaf Stamm, Horst Ruppach, Minu Youngkin

15 April 2025

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Armor CAR T cells with enhanced potency for cancer immunotherapy

Saba Ghassemi

08 April 2025

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Achieving rapid microbiological monitoring in fill-finish with biofluorescent particle counters: a collaborative case study

M Dingle, A Carwell, M J. Miller et al

08 April 2025

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Fit-for-purpose analytical development for an emerging cell therapy landscape

Jie Wei, Damian Marshall, Florian Durst

03 April 2025

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Strategies for streamlined manufacturing and analytics in CGT development

Laura Mueller, Silvio Weber, Dirk Windgassen

01 April 2025

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Transforming cell therapy manufacturing: smart automation & genetic modification for scalable success

Peter Szaraz, Tessel Hammink

20 March 2025

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AAV capsid analysis and quantification with chromatography and ultracentrifugation-based techniques

Andreja Livk, Sebastijan Peljhan

27 February 2025

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Modernizing viral clearance study strategy: regulatory updates and industry best practices

Audrey Chang, Kathleen Kenney

25 February 2025

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Big pharma case study: alpha testing of a generic anti-AAV kit and comparison to in-house methods

Kira Hedström, Eva-Maria Thüring

30 January 2025

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From concept to clinic: overcoming the challenges of potency assays in cell and gene therapy development

Audrey Chang, Joe Newcome

10 December 2024

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Quality by design in mRNA manufacturing: at-line monitoring coupled with DOE for higher IVT yield and efficiency of purification

Rok Sekirnik

03 December 2024

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Advances in the separation and analysis of AAV-based gene delivery vectors

Jukka Kervinen, Yuliya McAnany

21 November 2024

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Process in the product: a new analytical tool for AAV production optimization and monitoring

Blaž Bakalar, Ivana Petrović Koshmak

19 November 2024

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Emerging global trends and regulatory opportunities in cell therapies for cancer

Kim Watanabe, Sushama Sankpal, Kasey Kime

13 November 2024

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Harnessing flow cytometry for high-throughput screening in immunotherapy development

Kevin Chen, Jonah Riddell, Raffaello Cimbro

12 November 2024

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mRNA characterization - from 5’ cap to poly (A): what IPRP-LC–MS can tell you

Roxana Eggleston

06 November 2024

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Interferometric light microscopy for rapid virus titering and characterization of lipid nanoparticle preparations 

Ben Josey

31 October 2024

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From development to manufacturing: ensuring quality and functionality in gene therapy

Chris Heger

23 October 2024

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Application of CGE in cell and gene therapy

Ryan Hylands, Luiza Chrojan

22 October 2024

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