CELL AND GENE THERAPY INSIGHTS

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Multiple CQAs from a single dataset: advancing lentiviral vector-based cell & gene therapy

Multiple CQAs from a single dataset: advancing lentiviral vector-based cell & gene therapy

Tilak Gupta, Rengarajan Pelapur, Jana Škařupová
03 December 2025
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 Unlock advanced strategies in cell therapy analytics

Unlock advanced strategies in cell therapy analytics

S Krause, K Shum, A Chandran et al
25 November 2025
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 Scaling AAV5 production from bench to industrial scale: strategies for efficient, de-risked manufacturing

Scaling AAV5 production from bench to industrial scale: strategies for efficient, de-risked manufacturing

Anne MacIntyre, Sara Krekels
18 November 2025
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 Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Kathleen Kenney
05 November 2025
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 Cell therapy analytics and CMC: balancing innovation with standardization

Cell therapy analytics and CMC: balancing innovation with standardization

Jay Tanna
05 November 2025
Commentary
 Understanding GLP and cGMP regulatory framework for cell-based products to support early-phase clinical trials

Understanding GLP and cGMP regulatory framework for cell-based products to support early-phase clinical trials

A Jankelow, S R Bauer, G Almeida-Porada et al
05 November 2025
Regulatory perspective
Practical process development strategies to prepare AAV downstream operations for manufacturing

Practical process development strategies to prepare AAV downstream operations for manufacturing

T Elich, K Bodige, J Guzman et al
28 October 2025
Expert Insight
 Process and analytical development during AAV manufacturing platform evolution

Process and analytical development during AAV manufacturing platform evolution

Jack Jinqi Ren, Ning Ding
22 October 2025
Review
 What do product-specific CQAs tell us about rAAV-based in vivo gene therapy products?

What do product-specific CQAs tell us about rAAV-based in vivo gene therapy products?

Yan Zhi
21 October 2025
Viewpoint
 Optimizing upstream cell culture with rapid at-line and in-line analytics

Optimizing upstream cell culture with rapid at-line and in-line analytics

Nick Randall, Ethan Bossange
16 October 2025
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 Impurities in viral-based therapeutics: mastering residual hcDNA: a harmonized approach for AAV gene therapies

Impurities in viral-based therapeutics: mastering residual hcDNA: a harmonized approach for AAV gene therapies

R Sundar, X Mi, A Lavoie et al
15 October 2025
Expert Insight
 Residual DNA testing: enhancing efficiency and regulatory compliance  

Residual DNA testing: enhancing efficiency and regulatory compliance  

Shriya Sahu
07 October 2025
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 How far have AAV platforms taken us? Lessons from a CDMO on accelerating time-to-clinic

How far have AAV platforms taken us? Lessons from a CDMO on accelerating time-to-clinic

Ify Iwuchukwu
07 October 2025
Innovator Insight
 Modular iPSC workflow for allogeneic cell therapy applications: from iPSCs to iNKs

Modular iPSC workflow for allogeneic cell therapy applications: from iPSCs to iNKs

Omar Farah
03 October 2025
Innovator Insight
 Deep phenotypic and cytotoxicity characterization of NK cells cultured with chemically defined additives

Deep phenotypic and cytotoxicity characterization of NK cells cultured with chemically defined additives

Rebecca Nickle
03 October 2025
FastFacts
 Overcoming CMC hurdles in TIL therapy: strategic insights from a clinical-stage biotech

Overcoming CMC hurdles in TIL therapy: strategic insights from a clinical-stage biotech

Alex Lei, Sabrina Carmichael
02 October 2025
Innovator Insight
 Reaching cellular immunotherapy milestones faster: real-world insights

Reaching cellular immunotherapy milestones faster: real-world insights

B Engels, M Mues, A Mitra et al
30 September 2025
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 Tumor-infiltrating lymphocyte therapies: personal, powerful, with possibilities for improvement

Tumor-infiltrating lymphocyte therapies: personal, powerful, with possibilities for improvement

Sergio Ribeiro, Therese Choquette
30 September 2025
Expert Insight
 AAV production and purification: key steps from design to GMP readiness

AAV production and purification: key steps from design to GMP readiness

G Ganjam, E Jackson-Holmes, F Leseigneur et al
29 September 2025
Innovator Insight
 Achieving scalable, high-yield plasmid DNA purification processes

Achieving scalable, high-yield plasmid DNA purification processes

Klemen Božič
25 September 2025
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 Viral vector manufacturing: optimization through culture, QC and regulatory standards

Viral vector manufacturing: optimization through culture, QC and regulatory standards

James Cody, Megha Sharma, Giovanna Gayosa
23 September 2025
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