BioInsights - Vol 8 Issue 11

CELL & GENE THERAPY INSIGHTS

Vol 8 Issue 11

Cell & Gene Therapy Vol 8 Issue 11

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Featuring

Issue Spotlight: Tools of tomorrow
Other articles

Tools of tomorrow

Expert Insight

Exosomes: next generation vectors for drug delivery & gene therapy

Exosomes: next generation vectors for drug delivery & gene therapy

Jess Morhayim, Jeroen de Vrij

12 December 2022

Harnessing the power of design of experiments for cell therapy research & process development

Harnessing the power of design of experiments for cell therapy research & process development

Sean O’Farrell

30 November 2022

Innovator Insight

Viral vector manufacturing process: addressing bottlenecks with innovative solutions

Viral vector manufacturing process: addressing bottlenecks with innovative solutions

Rachel Legmann

14 December 2022

Interview

Leveraging cellular immunotherapy at the cutting edge of autoimmune disease R&D

Leveraging cellular immunotherapy at the cutting edge of autoimmune disease R&D

Silvio Manfredo-Vieira

12 December 2022

Key priorities for cell & gene therapy manufacturing evolution in 2023 & beyond

Key priorities for cell & gene therapy manufacturing evolution in 2023 & beyond

David DiGiusto

28 November 2022

Regulatory Insight

How to secure & standardize your cell expansion

How to secure & standardize your cell expansion

Paula Villaescusa Sánchez, Anette Brass

26 January 2023

Review

Emerging technologies & companies in cell & gene therapy manufacturing

Emerging technologies & companies in cell & gene therapy manufacturing

Julien Sylvestre, Philip Conti-Permanne

FastFacts

Cell collection in cell therapy — quality matters

Cell collection in cell therapy — quality matters

Sara Lewandowski

14 December 2022

Short Communication

Thinking ahead: developing biosynthetic blood to anticipate donor drought

Thinking ahead: developing biosynthetic blood to anticipate donor drought

A Goldman, S Kilpatrick, M Madrid et al.

Journal articles

Perspective

The parent–child IND approach: an interpretation of FDA’s guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The parent–child IND approach: an interpretation of FDA’s guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

Timmothy Taps

Innovator Insight

Walking on thin ice: controlled freezing & thawing of pharmaceutical active molecules

Walking on thin ice: controlled freezing & thawing of pharmaceutical active molecules

Barbara Fischer

14 December 2022

RCA-free production of third generation adenoviral vectors

RCA-free production of third generation adenoviral vectors

N Scheer, H Kewes, U Kettling

15 December 2022

Lentiviral titer determination: rapid & robust molecular methods suitable for validation

Lentiviral titer determination: rapid & robust molecular methods suitable for validation

22 February 2023

Commentary

Key considerations & challenges in developing flow cytometry assays for cell & gene therapy products

Key considerations & challenges in developing flow cytometry assays for cell & gene therapy products

Ajit Kamath

12 December 2022

Interview

Sharing personal experience on the development of cell therapy technology, quality & analytics since the 1990s & the application of ‘phase appropriate GMPs’ to cell therapy development

Sharing personal experience on the development of cell therapy technology, quality & analytics since the 1990s & the application of ‘phase appropriate GMPs’ to cell therapy development

Amnon Eylath

19 December 2022

FastFacts

Viral vector production guide part 1: choosing the correct grade for your gene therapy application

Viral vector production guide part 1: choosing the correct grade for your gene therapy application

20 December 2022

Viral vector production guide part 2: considerations of scaling up GMP

Viral vector production guide part 2: considerations of scaling up GMP

Daniel Smith

20 December 2022

Find your competitive advantage through custom buffer formulations for CAR-T manufacturing

Find your competitive advantage through custom buffer formulations for CAR-T manufacturing

Benito Delgado

Synergize your tools to generate process insights

Synergize your tools to generate process insights

Rohit Saklecha, Andres Castillo

15 December 2022

Webinar Digest

Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Mike Brewer

15 December 2022

Poster

Manufacturing considerations underpinning viral & non-viral platform selection

Manufacturing considerations underpinning viral & non-viral platform selection

A Hagerman, A Noyes, V Slepushkin et al.

15 December 2022

Regulatory requirements and product attributes for cGMP viral vector production

Regulatory requirements and product attributes for cGMP viral vector production

Scott Cross, Shikha Mishra

19 December 2022

Corrigendum

CORRIGENDUM to Purification of therapeutic & prophylactic mRNA by affinity chromatography

CORRIGENDUM to Purification of therapeutic & prophylactic mRNA by affinity chromatography

J Grinsted, J Liddell, E Bouleghlimat et al.