All too frequently, early-stage companies are failing to get the drug they've developed to market. Scaling up and commercialising new products comes with many challenges including: meeting commercial requirements; regulatory compliance; and securing funds for development and manufacturing. Kai Lipinski, PhD, chief scientific officer of Vibalogics, a Recipharm company, focuses on oncolytic viruses (OVs) to explain the considerations early-stage drug developers should make to help overcome these challenges and deliver their products to market successfully.
Key insights:
- Oncolytic viruses could be ideal for use in combination with other traditional treatments, as they have the ability to specifically target, infect, and lyse cancer cells, as well as trigger an immune response to these cells.
- Oncolytic virus developers must make informed decisions at every step of production based on the needs of the project, from choosing between suspensions and adherent cell cultures to selecting the method of virus recovery.
- Developers of oncolytic viruses must take time to ensure that there is a balance between quality and speed by incorporating Quality by Design (QbD) into processes as early as possible.
- Estimations and considerations into the volumetric production that will be needed at the final clinical or commercial scale should be made early, to prevent unexpected changes and setbacks in the more costly later stages.
Unique challenges with new oncolytic virus therapies
Advances in molecular engineering and innovative new technologies in the past 10 years have drastically broadened the drug product landscape, offering a diverse array of new or alternative therapeutics.