Cell and Gene Therapy Insights Volume 12 Issue 9

CELL AND GENE THERAPY INSIGHTS

Volume 12 Issue 9

Cell and Gene Therapy Insights Volume 12 Issue 9

Download PDF

Featuring

Issue Spotlight: Cell therapy analytics/CMC
Vectors focus: Novel non-viral & viral vector R&D
Other articles
Webinars

Cell therapy analytics/CMC

Research Article

Quality by Design in analytical development for cell therapies: using the analytical target profile to meet ICH Q14 expectations

I Zamora-Mármol, V Toledano, D Pérez-Cabrera et al.

Interview

Regulating for innovation: the MHRA’s ambition to make the UK a first-launch market for advanced therapies

Regulating for innovation: the MHRA’s ambition to make the UK a first-launch market for advanced therapies

Harnessing multiple immune pathways to drive anti-tumor activity

Harnessing multiple immune pathways to drive anti-tumor activity

Frank Borriello

Novel non-viral & viral vector R&D

Review

Recombinant AAV Production Platforms: Comparative insights for gene therapy manufacturing

Recombinant AAV Production Platforms: Comparative insights for gene therapy manufacturing

Sylvain Cecchini, Krishna Mohan Parsi, Robert Kotin

Commentary

Gene therapy with non‑viral vectors

Gene therapy with non‑viral vectors

Munia Ganguli, Mannat Kaur Boonga, Divya Rao

articles

Innovator Insight

From manual flask‑based culture to GMP bioreactor expansion: automation strategies and data for adherent cell manufacturing

From manual flask‑based culture to GMP bioreactor expansion: automation strategies and data for adherent cell manufacturing

Nathan Frank, Mandana Haack-Sørensen

Cutting AAV cost per dose: a plasmid-free platform from 200L to commercial scale

Cutting AAV cost per dose: a plasmid-free platform from 200L to commercial scale

Jun Xie, PhD, Robert Leydon

Cell therapy manufacturing without late surprises: contamination risk, QC timing, and patient-specific workflows

Cell therapy manufacturing without late surprises: contamination risk, QC timing, and patient-specific workflows

D M. Colleluori, PhD MBA, S Peterson, B Flutter, PhD

Redefining AAV manufacturing: a case study on improving AAV2 and AAV9 titers & percent full capsids while reducing production costs

Redefining AAV manufacturing: a case study on improving AAV2 and AAV9 titers & percent full capsids while reducing production costs

Devan Puhl, PhD, Leisha Kopp

From EV to LV: Scalable purification using membrane chromatography

From EV to LV: Scalable purification using membrane chromatography

Franziska Bollmann, Swapnil Chaudhari

Rethinking mycoplasma testing: 1-hour results in cell and gene therapy QC case study

Rethinking mycoplasma testing: 1-hour results in cell and gene therapy QC case study

Marc Meichenin, Jeremy Robertson

Expanding the role of ddPCR in AAV gene therapy: from analytical characterization to quality control

Expanding the role of ddPCR in AAV gene therapy: from analytical characterization to quality control

Sharath Babu G.R., PhD

Scaling iPSC-derived therapies to GMP: lessons from immune and regenerative medicine programs

Scaling iPSC-derived therapies to GMP: lessons from immune and regenerative medicine programs

Stefan Braam, Anne-Sophie Lebrun

Sterile fluid transfer in advanced therapy manufacturing: eliminating the biosafety cabinet bottleneck

Sterile fluid transfer in advanced therapy manufacturing: eliminating the biosafety cabinet bottleneck

Troy Ostreng

Unlocking two-fold LVV recovery with integrated affinity capture for high-productivity manufacturing

Unlocking two-fold LVV recovery with integrated affinity capture for high-productivity manufacturing

Early-stage decisions that shape cell therapy development

Early-stage decisions that shape cell therapy development

J Liter, M Parvizi, M Heidaran et al.

Scaling autologous CAR-T manufacturing for autoimmune and larger patient populations

Scaling autologous CAR-T manufacturing for autoimmune and larger patient populations

S O. Krause, PhD, K Jorgensen, MS, A Schlinker, PhD et al.