Session: Application of Quality by Design in Drug Substance Process Development

The pharmaceutical industry is increasingly implementing Quality by Design (QbD) to ensure robust and efficient processing through novel applications of process knowledge, technology, and risk management. Speakers for this session should include topics describing their application of QbD principles with examples such as determining critical process parameters (CPPs), mapping of design spaces (DS), controlling processes in real-time, and the developing appropriate control strategies for small and large molecule drug substance processes.