BioInsights - Vol 9 Issue 6

CELL AND GENE THERAPY INSIGHTS

Vol 9 Issue 6

Cell and Gene Therapy Insights Vol 9 Issue 6

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Featuring

Issue Spotlight: Gene therapy CMC and analytics
Other articles
Webinars

Gene therapy CMC and analytics

Lauren Drouin

Guest Editor:

Lauren Drouin, Director, Analytical Development at Alexion, AstraZeneca Rare Disease

Foreword

Gene therapy CMC and analytics—Foreword

Gene therapy CMC and analytics—Foreword

Lauren Drouin

Expert Insight

Optimizing ddPCR assay for characterizing AAV vector genome integrity

Optimizing ddPCR assay for characterizing AAV vector genome integrity

A Shevade, J Reeves, A D Tustian

Interview

Identifying and leveraging viral vector critical quality attributes & critical process parameters using process analytical technologies

Identifying and leveraging viral vector critical quality attributes & critical process parameters using process analytical technologies

Jonathan Appleby, John Churchwell

Assessing the AAV analytic toolkit: considerations for application & regulatory compliance

Assessing the AAV analytic toolkit: considerations for application & regulatory compliance

Juliette Reviron

Podcast

Interview: Navigating the complexities of biodistribution, transgene expression & vector shedding in gene therapy development

Interview: Navigating the complexities of biodistribution, transgene expression & vector shedding in gene therapy development

FastFacts

Technology transfer process excellence with an AAV comparability study

Technology transfer process excellence with an AAV comparability study

Isabel Guerrero Montero

Regulatory perspective

Facing potential chemistry, manufacturing, & control (CMC) development challenges with recombinant adeno-associated viral vectors: available regulatory guidance & recommendations

Facing potential chemistry, manufacturing, & control (CMC) development challenges with recombinant adeno-associated viral vectors: available regulatory guidance & recommendations

Stuart Beattie

Journal articles

Innovator Insight

Let the cells thrive: the next generation of cell expansion

Let the cells thrive: the next generation of cell expansion

H Fabre, M Barbisin, M Knaub

Enabling instrument connectivity through digital automation

Enabling instrument connectivity through digital automation

Bruce Greenwald, Elizabeth Wahl

Scale-up and delivery of allogeneic cell therapies to large patient populations

Scale-up and delivery of allogeneic cell therapies to large patient populations

M Langtry, K Panchalingam, I Friedrich Ben-Nun

Development of anti-AAV assay for detection of pre-existing AAV immunity

Development of anti-AAV assay for detection of pre-existing AAV immunity

John Chappell, Zhe Liu

How can the gene therapy industry drive down the cost of goods to better serve patients?

How can the gene therapy industry drive down the cost of goods to better serve patients?

Emmanuelle Cameau

Podcast

Modernizing cell therapy manufacturing to reduce vein-to-vein times

Modernizing cell therapy manufacturing to reduce vein-to-vein times

David Backer, Tony Ward

Poster

Driving the expansion of mRNA into the therapeutic sphere

Driving the expansion of mRNA into the therapeutic sphere

A Becerra, A Kuhn, M Kurtoglu

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

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

George Buchman, Thomas VanCott

Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing

Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing

Michael Brewer

Overcoming challenges in scaled manufacturing of iPSC-derived cells

Overcoming challenges in scaled manufacturing of iPSC-derived cells

A Steinbach, D Mann, M Diakatou et al.

Early-stage considerations for accelerating cell and gene therapy commercialization

Early-stage considerations for accelerating cell and gene therapy commercialization

Sabrina Carmichael

Aldevron case study: validation of mRNA concentration determination using variable pathlength spectroscopy

Aldevron case study: validation of mRNA concentration determination using variable pathlength spectroscopy

J Ferraiolo, T Alvine, J Long

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

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

Michael Brewer

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

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

J Sable, L Bellot, K Doucette

Utilizing an automation-on-demand analytical tool for cancer immunotherapy

Utilizing an automation-on-demand analytical tool for cancer immunotherapy

Christoph Eberle

Three distinct analytical ultracentrifugation methods for virus and viral vector characterizations

Three distinct analytical ultracentrifugation methods for virus and viral vector characterizations

Susumu Uchiyama

Expanding access to gene therapies through novel cell lines and dPCR technologies

Expanding access to gene therapies through novel cell lines and dPCR technologies

J Loganathan, A Noyszewski, M Voigt

AAV and lentiviral titer determination - past, present, and future

AAV and lentiviral titer determination - past, present, and future

J Bechill, P Wang, M White

Harnessing mass photometry for AAV sample characterization in GMP-regulated environments

Harnessing mass photometry for AAV sample characterization in GMP-regulated environments

Cátia Crespo

Accelerating analysis of viral vector titer, process impurities, and contaminants

Accelerating analysis of viral vector titer, process impurities, and contaminants

J Chappell, J Norton, I Osorio Querejeta et al.

Strategies to accelerate AAV chromatography process development

Strategies to accelerate AAV chromatography process development

Kelley Kearns

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

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

Nejc Pavlin