Automated plasmid assembly: a perspective from early drug discovery

S Ahammu, J Chi, T Edström et al

18 December 2024

Expert Insight

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

Damian Marshall, Kayleigh Thirlwell

02 December 2024

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Enhancing AAV process quality and efficiency: three case studies highlighting the benefits of upgraded analytics on downstream process development

E Hudspeth, I Green, T Dewosky et al

11 November 2024

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Analytics for cell and gene therapy products in early development: points to consider before preparing an IND for a first-in-human clinical trial

William E Janssen, Scott Burger

15 October 2024

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MHRA regulatory considerations for the quality of mRNA products

Ka-Wai Wan, Francis Galaway

22 May 2024

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Raw materials and supplies for cell therapies: end to end expectations and best practices

Lili Belcastro

15 May 2024

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Optimizing ddPCR assay for characterizing AAV vector genome integrity

Aishwarya Shevade, John S Reeves, Andrew D Tustian

03 August 2023

Expert Insight

Expanding the analytical toolbox to address complex cell-based therapies

Nathan C Manley, Samuel JI Blackford

18 November 2022

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Adeno-associated virus adsorption on different surfaces relevant to production of pre-clinical & clinical material

Amanda Zhang, Sara Cook, Ayda Mayer

01 October 2022

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Analytical toolkit for rapid formulation development of rAAV gene therapies

Julie Yu Wei, Ying Cai, James Warren

22 October 2021

Expert Insight

Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

D Chu, H Acharya, E Springfield et al

21 October 2021

Expert Insight

The Chemistry Manufacturing and Controls (CMC) section of gene therapy-based INDs: overview in a changing landscape

Gabriela Denning, PhD

18 October 2021

Expert Insight

Addressing sampling challenges in early phase cell therapy manufacturing

Stephanie Mgebroff

13 May 2021

Expert Insight

The role of big data analytics in digitized manufacturing

Damian Marshall, John Churchwell, Marc-Olivier Baradez

13 May 2021

Expert Insight

Measurement: the central nervous system of a quality manufacturing line for tissue engineering and regenerative medicine products

M Clare McCorry, R Robinson-Zeigler, R McFarland et al

25 November 2020

Expert Insight

The role of flow cytometry in advanced therapy medicinal products

Theo Nastos, PhD

20 November 2020

Expert Insight

Development and validation of quantitative real-time PCR for the detection of residual HEK-293 host cell DNA update

Kara Norman

20 October 2020

Expert Insight

Towards individualized, low toxic conditioning in autologous gene-transduced hematopoietic cell transplantation

Rick Admiraal, Susan Prockop, Jaap Jan Boelens

18 November 2019

Expert Insight

CRISPR surgery for inherited retinal diseases: landmarks in the 21st century

Stephen H Tsang, Alexander Chai

18 November 2019

Expert Insight

Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review

E Fritsche, M Elsallab, M Schaden et al

18 November 2019

Expert Insight

Bayesian Phase 1/2 trial designs and cellular immunotherapies: a practical primer

Jordan Gauthier, Ying Yuan, Peter Thall

18 November 2019

Expert Insight