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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
‘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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