mRNA Synthesis Considerations for Vaccine and Therapeutic Development

New immunotherapies are generating unprecedented clinical response. However, immune activation by I/O agents can also cause notable and potentially fatal clinical toxicity, such as cytokine storms, which is not observed in preclinical studies. Immuno-safety has therefore become a major clinical concern, which needs to be sufficiently addressed in early preclinical drug development.

As gene-modified cell therapies advance to address new indications, the need for rapid development of robust manufacturing processes becomes increasingly important.

The recently published revision to Eudralex Vol. 4 Annex 1, clarified current expectations for manufacture of sterile medicinal products in light of improved process understanding and advances in processing technologies.

It's estimated than less than 10% of investigational anti-cancer drugs successfully achieve FDA approval for clinical use. This is often attributed to the fact that it’s difficult to identify patients whose tumors are most likely to respond to a specific treatment. Patient derived xenografts (PDXs) are bringing new hope when it comes to this challenging task, yet finding the ideal animal model to grow the PDX tumors to test new therapies can be challenging. The new B-NDG mouse model is our newest triple immunodeficient mouse with proven performance in cancer and immuno-oncology research.