BioInsights - Gene therapy CMC and quality control - spotlight

CELL & GENE THERAPY INSIGHTS

October 2021

Gene therapy CMC and quality control

Download PDF

Foreword

Gene therapy CMC and quality control

Gene therapy CMC and quality control

Christine Le Bec

20 October 2021

Expert Insight

Analytical toolkit for rapid formulation development of rAAV gene therapies

Analytical toolkit for rapid formulation development of rAAV gene therapies

J Wei, Y Cai, J Warren

21 October 2021

Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

D Chu, H Acharya, E Springfield et al.

20 October 2021

The Chemistry Manufacturing and Controls (CMC) section of gene therapy-based INDs: overview in a changing landscape

The Chemistry Manufacturing and Controls (CMC) section of gene therapy-based INDs: overview in a changing landscape

Gabriela Denning, PhD

17 October 2021

Innovator Insight

Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges

Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges

Yi Fang Lee, Srinath Kashi Ranganath

24 October 2021

Interview

Advancing real-time monitoring of AAV vector processes

Advancing real-time monitoring of AAV vector processes

12 October 2021

Next steps in the evolution of AAV vector characterization technologies

Next steps in the evolution of AAV vector characterization technologies

Eduard Ayuso

Addressing challenges in characterizing novel AAV capsids and gene editing platform-driven therapeutics

Addressing challenges in characterizing novel AAV capsids and gene editing platform-driven therapeutics

Lauren M Drouin

Podcast

Advancing real-time monitoring of AAV vector processes

Advancing real-time monitoring of AAV vector processes

Rachel Legmann, Joe Ferraiolo

10 October 2021

Webinar Digest

Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

Dalip Sethi, Annie Cunningham

4 November 2021

Webinars

Optimization of AAV production for high-yielding and scalable GMP processes

Optimization of AAV production for high-yielding and scalable GMP processes

C PhD, M Porte, B PhD et al.

20 October 2021

Considerations for developing scalable and efficient collection network processes

Considerations for developing scalable and efficient collection network processes

L Anderson, S Butler, A Montalvo,

28 October 2021