Stability Considerations for Personalized Medicine: Regulatory and Practical Perspectives
Stability Considerations for Personalized Medicine: Regulatory and Practical Perspectives Stability Considerations for Personalized Medicine: Regulatory and Practical Perspectives Introduction The rapid rise of personalized medicine—ranging from autologous cell therapies to gene-editing and mRNA-based treatments—has transformed drug development paradigms. These therapies are often produced in small batches tailored to individual patients, creating complex challenges in manufacturing,…