Ensuring compliance through collaboration: managing raw material changes in cell and gene therapy regulatory filings

Kasey Kime, Xiao Peng

20 March 2025

Innovator Insight

Worth the switch? Enhancing process performance for cell therapy manufacturing with an animal component-free raw material strategy

Phil Morton, Shanya Jiang

03 March 2025

Innovator Insight

Next-generation risk mitigation in the temperature-controlled supply chain for advanced therapies with ISO 21973 compliance

Edward Grimley, Leanne Kodsmann

04 December 2024

Innovator Insight

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

Michael Brewer

14 September 2023

Innovator Insight

Addressing regulatory guidance for HEK293 cells & AAV-based therapeutics manufacturing

Michael Brewer

23 August 2023

Innovator Insight

Commercializing cell & gene therapies: a perspective from the quality function

Christoph Meyer, Andreas Wirth

09 February 2023

Innovator Insight

Automating the final cell therapy bioprocess step for robust CMC/GMP compliance

Tracy Moore, Delara Motlagh

07 February 2022

Innovator Insight

Understanding raw material performance: quality and consistency of cytokines for translation to the clinic

Bernd Leistler

18 October 2021

Innovator Insight

Navigating regulations: novel cell therapy platforms and their path to clinical manufacturing

N Bauer, N Calhoun, A Davies et al

11 August 2021

Innovator Insight

CMC obstacles in cell and gene therapy: four solutions to solve six challenges

Subbu Viswanathan, Marc Puich

10 May 2021

Innovator Insight

Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective

Alistair Michel, David Neville

25 March 2021

Innovator Insight

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials - ANIMATION

Kasey Kime, Jerrod Denham, Christopher Bravery

06 October 2020

Innovator Insight

Commercial Lessons for Clinical Success

Simon Ellison, Heidi Hagen, Christophe Suchet

19 December 2018

Innovator Insight

Strategic & practical considerations in raw material selection & sourcing for cell therapies

David Wellis, Robert Tressler

10 April 2017

Innovator Insight

A US Cell Therapy Regulatory Toolkit

E Culme-Seymour, J Lawford-Davies, M Carpenter et al

14 September 2015

Innovator Insight