Safety assays for quality control of ATMPs: improved mycoplasma detection for cell-based biotherapeutics
Jens Björkman, Andreas Hecker
Manufacturing Quality Control for Plasmid DNA Critical Starting Materials
A Frazer, L R. Salvitti, S Lovatt et al
Next-generation sequencing in adventitious agent testing: navigating regulatory acceptance
Olaf Stamm, Horst Ruppach, Minu Youngkin
Achieving rapid microbiological monitoring in fill-finish with biofluorescent particle counters: a collaborative case study
M Dingle, A Carwell, M J. Miller et al
Fit-for-purpose analytical development for an emerging cell therapy landscape
Jie Wei, Damian Marshall, Florian Durst
CAR-T manufacturing intensification: the next wave of CAR-T commercialization
A Bersenev, E Kleiren, J Knighton et al
03 April 2025
Innovator Insight
Strategies for streamlined manufacturing and analytics in CGT development
Laura Mueller, Silvio Weber, Dirk Windgassen
Transforming cell therapy manufacturing: smart automation & genetic modification for scalable success
Peter Szaraz, Tessel Hammink
AAV capsid analysis and quantification with chromatography and ultracentrifugation-based techniques
Andreja Livk, Sebastijan Peljhan
Maximizing CAR-T cell yields: scalable solutions with perfusion and stirred-tank bioreactors
J Hengst, Q Rafiq, R Ladi et al
27 February 2025
Innovator Insight
Achieving robust and scalable AAV empty/full capsid separation for gene therapy
Julio Huato, Mark Schofield
26 February 2025
Innovator Insight
Modernizing viral clearance study strategy: regulatory updates and industry best practices
Audrey Chang, Kathleen Kenney
Investing in early-stage stem cell therapy developers
Stijn Heessen, Kristian Tryggvason
21 February 2025
Viewpoint
Big pharma case study: alpha testing of a generic anti-AAV kit and comparison to in-house methods
Kira Hedström, Eva-Maria Thüring
Early-stage analytical development strategies for cell therapy
Ramon Mendoza, Kyle Carter, Seth Peterson
16 January 2025
Expert Roundtable