Understanding The Requirements Of Viral Vector Analytical Development To Clinic And Beyond

By Pratima Cherukuri, Chief Scientific Officer, Genezen

Analytical method development, qualification, and validation are an integral part of viral vector (VV) manufacturing and are essential to ensure the safety, quality, and efficacy of the final product.

While having the necessary expertise needed for appropriate assay design is essential in analytical method development, VV manufacturers must prepare for numerous challenges on their VV product’s journey to market. In a quickly evolving and relatively new therapeutic area like cell and gene therapy (CGT), staying abreast of dynamic regulatory requirements will be fundamental to success.

Providing unmatched expertise in gammaretroviral and lentiviral vector development and manufacturing, Genezen is here to help overcome the difficulties of forming a successful analytical method development strategy.

In our analytical whitepaper, you will learn about the key challenges and considerations needed when building a robust approach to VV analytical development, including:

• Adapting to potential regulatory adaptations
• Determining the right time to adhere to cGMP requirements
• Forming an in-depth understanding of VV characteristics with analytical methods
• Overcoming the unique analytical challenges presented by VVs
• Navigating the timeline to analytical method validation.