The comprehensive characterization of critical quality attributes (CQAs) for the safety and efficacy of cell and gene therapies remains a key challenge for the sector. Analytical development teams are required to address issues such as identification, characterization, and quantification 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 cell therapy and 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