Exploring scalable, data-driven AAV manufacturing to achieve high yield and quality across serotypes

Xiaojun Liu, Chris Brown, Yeonji Kim

23 July 2025

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Strategic human raw material selection for cell therapy manufacturing

Daniel Benitez-Ribas

16 July 2025

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Exploring key regulatory considerations to ensure patient safety in the gene therapy space

L Shaw, C Le Bec, M Orio et al

01 July 2025

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Actionable insights for overcoming CMC challenges in TIL therapy: GRIT’s strategic approach

Alex Lei, Sabrina Carmichael

19 June 2025

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How do I ensure my early-stage analytical development is ‘phase-appropriate’? Top 5 tips

03 June 2025

Infographic

A structured approach to addressing leachable risk in cell and gene therapies

Jason Creasey

24 April 2025

Expert Insight

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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A path toward universal agreement on fulfilling the need for rapid and reliable sterility assays in gene therapy

Qin Xiang

14 April 2025

Viewpoint

Navigating analytical and regulatory hurdles in early-phase clinical cell therapy development

Vaibhav Patel

10 April 2025

Interview

Conducting 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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Advancing quality standards for gene therapies: a USP perspective

Fouad Atouf

08 April 2025

Interview

CAR-T manufacturing intensification: the next wave of CAR-T commercialization

A Bersenev, E Kleiren, J Knighton et al

03 April 2025

Innovator Insight

Advancing optogenetic therapies for retinal diseases: a regulatory vision

Ananta Ayyagari

24 March 2025

Interview

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