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

Audrey Chang, Kathleen Kenney

25 February 2025

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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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Emerging global trends and regulatory opportunities in cell therapies for cancer

Kim Watanabe, Sushama Sankpal, Kasey Kime

13 November 2024

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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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Preventing cross-contamination in cell therapy production

Josh Ludwig, Mary Kay Bates

01 October 2024

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Considerations in leveraging the Universal AAV Standard for dPCR to assess AAV genomes quantity and quality

Andrzej Noyszewski, Alex Deiulio

10 September 2024

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Advancing viral vector manufacturing with innovation: the importance of the cell line

Marguerite Campbell, Brian Tomkowicz

05 September 2024

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Discover the road to success for viral vector production: strategies, insights, and regulatory considerations

Samira Shore, Anne Gilbert, Jesse Bishop

20 June 2024

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Mastering the journey from initial method transfer to successful lot release for cell & gene therapies

A Chang, H Malicki, J Cheung et al

06 June 2024

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Considerations to optimize and act upon long-term follow-up studies for cell and gene therapies

K Wonnacott, L Pelloso, D Takefman et al

11 April 2024

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Overcoming challenges in cell therapy production: rapid sterility testing

Seth Peterson

13 March 2024

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Strategic raw material selection for cell therapy commercialization

Kasey Kime, Lili Belcastro, Kyle Hondorp

09 November 2023

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Pushing the boundaries of LNP production: an innovative analytical platform for evaluating vital LNP characteristics

Nejc Pavlin

26 September 2023

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How patient focus drives clinical trial results: the intersection of sponsor, CRO, site, and patient

K Kane, K Nealon, B Bratrude et al

07 September 2023

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Exploring and overcoming the challenges of cell and gene-modified cell therapy CMC

Julia Sable, Larry Bellot, Karen Doucette

25 July 2023

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Regulatory considerations and validation strategies for mycoplasma testing for cell-based therapies

Michael Brewer

20 July 2023

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Accelerating your gene therapy to patients: not all platforms are created equal

George Buchman, Thomas VanCott

22 June 2023

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How to increase speed from project initiation to IND filing for CGT products

Jennifer Cheung

08 June 2023

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