By: Dr. Stephen R. Byrn, a Charles B. Jordan Professor of Medicinal Chemistry in the College of Pharmacy

The Purdue BIRS program focuses on biotechnology innovation and regulatory science; because of its history, this Purdue program places a significant emphasis on pharmaceutical manufacturing. Initially, the program offered three certificate courses, including one on the molecular basis of manufacturing. This particular course has traditionally concentrated on the manufacturing of small molecule tablets, covering all related unit operations such as milling, granulation, and tablet coating. These elements remain integral to the program's current offerings. Still, new aspects of the pharmaceutical manufacturing course focus on lipid nanoparticle vaccine and drug product manufacture, therapeutic phage manufacture, and biologicals manufacture in general.

The program employs the six systems concept to serve as a conceptual structure for the manufacturing process, and there is a particular focus on processing. In the pharmaceutical manufacturing course, topics such as Active Pharmaceutical Ingredient (API) manufacturing are discussed, highlighting the significance of specifications and polymorphism. The course also explores various manufacturing methods for dosage forms and drug products, including standard granulation, compression, and roller compaction. The course includes laboratory sessions dedicated to small-molecule tablet manufacturing. Statistical approaches, including DOE, are included to provide an overview of modern approaches to optimizing manufacturing. Using statistics for product and process design helps achieve quality by design (QbD), strong development reports, and excellent regulatory submissions, and it allows continuous improvement. Validation and process validation is another important section of the course. The course includes online material, laboratory exercises, and workshops outlining how to interpret the data.

The course also emphasizes accelerated development and touches on sterile manufacturing and its challenges, especially highlighting the recent importance of injectable vaccines.

Manufacturing Class Expansion

The BIRS program has expanded its focus to include additional manufacturing methods, such as the production of monoclonal antibodies, cell therapy, phage therapy, and lipid nanoparticles. Laboratory exercises are being developed for nanoparticle manufacture by injection, as is done for RNA vaccines. The manufacturing of phage therapies is also included because phage therapy is gaining attention as a treatment for antibiotic-resistant infections without the use of antibiotics. This expansion is in response to the growing interest in mRNA vaccines spurred by the COVID-19 pandemic. The curriculum also covers the manufacturing of monoclonal antibodies.

Prepare to Address the Complex Challenges of Pharmaceutical Manufacturing and Regulation.

Beyond specific manufacturing techniques, the program addresses the risks associated with manufacturing processes, including strategies for risk reduction and monitoring. Quality by design principles are emphasized as critical components of the curriculum, aiding in the identification of critical quality attributes (CQA) and critical process parameters (CPP).

Regulatory aspects of pharmaceutical manufacturing are also a focus, with a noted overlap between the manufacturing and the regulatory and quality courses. The importance of this interconnection is highlighted throughout the program.

Finally, the program includes a review of manufacturing patents and intellectual property, underscoring the significance of these areas in pharmaceutical development. This comprehensive approach ensures that students are well-prepared to address the complex challenges of pharmaceutical manufacturing and regulation.