Optimizing Formulation,Process Design, and CMC to Achieve Target-Appropriate Biodistribution

Why do so many promising delivery systems fail before reaching the clinic? Despite strong early data, achieving consistent, target-appropriate biodistribution, while maintaining scalability and CMC robustness, remains a critical challenge for advanced therapeutics.

In this expert Q&A featuring Evan Turek, Senior Director of Business Development, and Theresa Logan, Head of Laboratory Operations at Phosphorex, you will gain insights into how formulation, process design, and CMC must work together to ensure successful clinical translation.

Learn why treating these disciplines as isolated workstreams can derail development, and how an integrated approach can help de-risk your program.

What You’ll Learn:

Why biodistribution remains a key hurdle for LNPs and polymeric systems
How formulation and process design jointly impact in vivo performance
Common pitfalls that cause promising candidates to fail during scale-up
The role of downstream processing in preserving product quality
How strong CMC strategies support IND readiness and regulatory success

Drawing on real-world experience, this article highlights how integrated development strategies can help maintain efficacy, ensure reproducibility, and de-risk the path to clinical advancement.

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