Principles of Product and Process Development

This course provides a comprehensive overview of biopharmaceutical product and process development, from early-stage research through clinical trials and commercial manufacturing readiness.

Students will learn how scientific, technical, and regulatory requirements guide product and process development activities, including expectations from agencies such as the U.S.

Food and Drug Administration throughout the development lifecycle.

The curriculum covers drug development processes, process design and optimization, scale-up strategies, technology transfer, regulatory compliance requirements, and the transition of products into clinical and commercial manufacturing environments.

Learners will gain practical skills in process development strategy, cross-functional collaboration, regulatory documentation, implementation of industry standards, and coordination of development activities that support efficient and compliant manufacturing operations.

This course prepares students for careers in bioprocess development, pharmaceutical manufacturing, process engineering, and regulatory affairs within the biotechnology and pharmaceutical industries.