Introduction to Downstream Process Development
Biological products, also referred to as biopharmaceuticals, are a class of extremely effective, life-changing medicines used for the prevention and treatment of a range of diseases. Therapeutic proteins are among the biggest selling biopharmaceuticals and are typically produced by genetically engineered cells. Processes to produce, recover, purify, and formulate these therapeutic proteins require numerous and (sometimes) complex steps.
This course focuses on designing processes for the recovery and subsequent purification of a target therapeutic protein. The steps involved are collectively referred to as the “downstream process.” Lectures will focus on (i) principles underlying the unit operations used in downstream bioprocesses (this course will cover centrifugation, homogenization, chromatography, and ultrafiltration) and (ii) how to obtain answers to the numerous questions involved in designing a downstream process for biopharmaceutical manufacturing. The latter involves selecting appropriate unit operations, identifying and specifying ranges for key process and performance parameters for each unit operation, and scaling development runs from bench- to production-scale.
Lab exercises build on lecture material by focusing on studies that reinforce fundamental principles and supply data to specify process parameter ranges, material attributes, and scale-up parameters.
At the end of this course, students should be able to:
- Describe the principles that underlie major unit operations used in downstream processing of biopharmaceuticals. The operations covered in this course are homogenization, centrifugation, chromatography, and ultrafiltration;
- Define terms associated with downstream processing and downstream process development;
- Design, execute and document bench-scale studies to determine appropriate operating ranges and scale-up parameters for downstream processing steps;
- Perform basic scale-up calculations for downstream unit operations;
- Given appropriate information about a target recombinant protein, "sketch" a process to recover and purify the protein. This includes selecting unit operations and placing them in a logical order.
BEC 330 or BEC 532
Students will be required to purchase a course pack, which includes lecture materials and laboratory modules.