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CELL AND GENE THERAPY INSIGHTS

Navigating the EU joint clinical assessment process: key considerations for manufacturers of ATMPs and oncology medicines

Navigating the EU joint clinical assessment process: key considerations for manufacturers of ATMPs and oncology medicines

Combining best practices and analytical reference materials to tackle challenges in AAV manufacturing

Combining best practices and analytical reference materials to tackle challenges in AAV manufacturing

Unravelling immunogenicity induced by Cas9 in gene therapy: a comprehensive commentary of current understanding and implications

Unravelling immunogenicity induced by Cas9 in gene therapy: a comprehensive commentary of current understanding and implications

Anna Lina Cavallo

08 November 2023

Overcoming challenges to CAR-T cell therapies in India

Overcoming challenges to CAR-T cell therapies in India

A Uppal, R Chakrabarti, N Chirmule et al

Regulatory & supply chain implications for plasmids as critical starting materials in the manufacture of viral vector gene therapy products

Regulatory & supply chain implications for plasmids as critical starting materials in the manufacture of viral vector gene therapy products

M Gosse, C Jones, D Jesus et al

The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

E Bicudo, I Brass, P Carmichael et al

30 September 2021

Outcomes from a cell viability workshop: fit-for-purpose considerations for cell viability measurements for cellular therapeutic products

Outcomes from a cell viability workshop: fit-for-purpose considerations for cell viability measurements for cellular therapeutic products

L Pierce, S Sarkar, L Li-Ying Chan et al

Finding quality in complexity: how cellular therapeutics are shifting analytical paradigms for clinical supply and product manufacturing

Finding quality in complexity: how cellular therapeutics are shifting analytical paradigms for clinical supply and product manufacturing

Vilma Jimenez Sabinina, Dominic Günter Hildebrand

Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Gary C du Moulin, PhD, MPH, RAC