Panel Discussion: The Crossroads of Science, Compliance & Process Development in Highly Potent Drug Manufacturing
Time: 2:00 pm
day: Conference Day One
Details:
As the pharmaceutical industry is increasingly shifting towards ADCs and high potency small molecules, the complexity of chemistry, manufacturing, and controls (CMC) grows exponentially as we find more unique challenges with developing and scaling these compounds efficiently.
In this dynamic 45-minute panel discussion, we will dive deep into the intricacies of balancing cutting-edge science and rigorous process development with the ever-evolving landscape of regulatory compliance:
- Exploring cutting-edge innovations in process chemistry, formulation, and drug substance development that drive efficacy of highly potent compounds
- Addressing significant challenges in transferring lab-scale processes for large-scale manufacturing to ensure both product quality and operator safety
- Navigating quality concerns that are unique to high potency drugs to control critical process parameters and prevent cross-contamination of products and batches
