The comprehensive characterization of critical quality attributes (CQAs) for the safety and efficacy of the viral vector material produced for gene therapy trials remains a key challenge for the advanced therapies sector. Viral vector analytical development teams are required to address issues such as identification, characterization, and enumeration of undesired contaminants such as mycoplasma.
With the CMC-related requirements of the US FDA, EMA, and other major regulatory agencies still evolving and steadily increasing in stringency, it is more important than ever to harness the cutting edge in analytical tools to improve the identification and measurement of these CQAs.
Fortunately, a new generation of analytical tools designed to meet the specific needs of viral vector production is arriving, offering the enhanced speed, sensitivity, and robustness that industry requires.
The following curated collection of content offers technical and strategic insights and practical advice relating to:
Analytical development
Cell therapy manufacturing
Expression systems
Mycoplasma testing
Regulatory CMC
Residual DNA testing
Vector production
Any Questions?
Content
Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing
Robust quantitation of residual host cell and plasmid DNA & oncogenic fragments in HEK-based viral vector manufacturing
Simplifying analytical development of viral vector production: robust and sensitive methods for common expression systems
Removing technological barriers to efficient large-scale LV vector production
Key factors to consider for successful cell therapy manufacturing: a case study
Residual DNA testing in viral vector manufacture: exploring the challenges and solutions
Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges
Manufacturing and analytics for lentivirus and AAV vectors: a visual and audio guide
Development & validation of a robust commercial solution for measuring residual kanamycin-resistant plasmid DNA
