BIO-288 Introduction to Biomanufacturing II
Introduction to Biomanufacturing II is a continuation of Introduction to Biomanufacturing I. While part I introduced students to the process of bringing a biopharmaceutical from "bench to bottle," this course focuses on the many functional areas specific to a biomanufacturing operation. Through a combination of lecture and laboratory (hands-on) activities, students will be introduced to the roles of these functional areas in the manufacturing process. Included in this exploration are the roles of technicians working in Environmental Health and Safety, Quality Control, Quality Assurance, and Validation. In addition, students will be exposed to basic analytical tools used in a manufacturing environment (RCA and FMEA). Students will continue the application of regulatory affairs introduced in part I of the course, and will follow proper documentation procedures as outlined in the Good Laboratory and Good Manufacturing Practices (Food and Drug Administration).