Process Design: Safe, scalable methods are developed for manufacturing Active Pharmaceutical Ingredients (APIs) and finished products, bridging the gap between laboratory-scale experiments and full-scale production.
Process Optimization: Continuous improvement focuses on enhancing efficiency, reducing costs and waste, increasing yields, and maintaining compliance with regulatory standards.
Scalability: A primary challenge is ensuring that processes developed during drug discovery can be scaled up for mass production without compromising product quality or safety.
Regulatory Compliance: Processes are designed to adhere to Good Manufacturing Practices (GMP) and meet the requirements of regulatory agencies such as the FDA and EMA.
Quality and Consistency: The ultimate objective is to ensure that each manufacturing process reliably produces high-quality products batch after batch.