Optimizing iPSC therapies: strategies for safe, cost-effective, and scalable manufacturing

K Bruce, K Bharti, I Barbaric et al

23 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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Ensuring compliance through collaboration: managing raw material changes in cell and gene therapy regulatory filings

Kasey Kime, Xiao Peng

20 March 2025

Innovator Insight

Streamlining the supply chain: insights on raw material sourcing and quality by design

Lara Silverman

19 March 2025

Interview

GMP or not? Understanding raw material quality grades and requirements for ATMP manufacturing

Lili Belcastro, Basak Clements, Claire Wartel

18 March 2025

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Raw and starting materials for cellular and gene therapy products

Gary du Moulin

04 March 2025

Review

Worth the switch? Enhancing process performance for cell therapy manufacturing with an animal component-free raw material strategy

Phil Morton, Shanya Jiang

03 March 2025

Innovator Insight

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

Audrey Chang, Kathleen Kenney

25 February 2025

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Regulatory innovations: why is the UK an attractive hub for CGT development?

Rehma Chandaria

13 February 2025

Interview

Early-stage analytical development strategies for cell therapy

Ramon Mendoza, Kyle Carter, Seth Peterson

16 January 2025

Expert Roundtable

‘Winning’ target product profiles for CAR-T cell therapies in oncology: critical success factors for commercially viable therapies

Clare Hague, Louise Street-Docherty, Frances Pearson

19 December 2024

Expert Insight

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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Pioneering quality control in biomanufacturing of cell and gene therapies

Dhruv Sareen, Jonathan Rodriguez

05 December 2024

Interview

Next-generation risk mitigation in the temperature-controlled supply chain for advanced therapies with ISO 21973 compliance

Edward Grimley, Leanne Kodsmann

04 December 2024

Innovator Insight

Interpreting the new FDA draft potency guidance: an RNA cell therapy perspective

Damian Marshall, Kayleigh Thirlwell

02 December 2024

Expert Insight

Emerging global trends and regulatory opportunities in cell therapies for cancer

Kim Watanabe, Sushama Sankpal, Kasey Kime

13 November 2024

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Phase-appropriate analytical control of cell therapy manufacture in early development stages

Vaibhav Patel

11 November 2024

Review

Revolutionizing cell and gene therapy with digitalization: a panel discussion with industry leaders

Caitlin Harrison, Rebecca Street-Howards, Kanchan Deshpande

08 October 2024

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Coming of age: an overview of the growing toolbox for gene editing and its use in CGT applications

C Fuentes, J Staudhammer, M Pope et al

07 October 2024

Review

Preventing cross-contamination in cell therapy production

Josh Ludwig, Mary Kay Bates

01 October 2024

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Beyond CRISPR: exploring the next frontier in gene editing technologies

Devyn Smith

18 September 2024

Interview