Overcoming Challenges In AAV And LV Viral Vector Manufacturing: How To Design And Launch A Successful Clinical Trial Manufacturing

By Mathias Kahl, Stephan Bauer, Dr. Daniel Köhler, Dr. Tobias Thom, Rico Hinrichs, Stefan Borutzki, Christina Pospisil, Dr. Rico Schmidt, Erik Arnold, Dr. Thomas Kreisig, IDT Biologika

The cell and gene therapy industry is experiencing rapid growth as new drugs hold the potential to treat and possibly cure a wide range of devastating diseases, including cancer. However, as a number of therapies advance toward clinical trials, drug sponsors are limited in their knowledge of how to design and launch a successful clinical trial manufacturing (CTM) process. In addition to optimizing their CTM process, it is paramount for sponsors to properly understand and implement the investigation and manufacturing of adeno-associated virus vectors (AAVs) and lentiviral vectors (LVVs). Without addressing these factors, sponsors face high costs, delays, and the possibility of failure to bring their drug to patients.

Collaborating with a CDMO with AAV and LVV manufacturing expertise can help you navigate the complex and evolving challenges of viral vector production. A reliable partner with established platform applications can manufacture clinical trial material on rapid timelines and build a process that conserves resources. Utilizing a CDMO’s highly efficient analytical testing capabilities is also crucial to help release your batches for trial faster. Learn more about how finding the right experienced partner can help you leverage the upstream and downstream technologies, analytical testing methods, and formulation strategies best suited for your product.