ALS 422: Bioseparations Laboratory
Course Number: ALS 422
Course Name: Bioseparations Laboratory
Year: Second-year
Semester: Spring
No. Units: .5
Faculty/Instructor(s): KiriLynn Svay Hedberg
Description
This half-unit laboratory course provides hands-on experience with many of the techniques and principles taught in the complimentary lecture course, ALS 429. A student cannot take ALS 422 without taking this lecture course at the same time, or at a prior time. It is imperative that students learn about the key scientific, engineering, and practical industrial aspects of the field through the lecture course. If a student takes both ALS 429 and 422, they should not only gain a broad understanding of these key issues, but should also have a certain degree of first hand experience and skill in purifying, concentrating, and formulating biopharmaceuticals at the pilot laboratory scale. PPM students taking this course should, at the same time, take both ALS 429 and ALS 331.
Textbook: None. There will be many handouts and resources posted on Sakai.
Prerequisites
Pre-requisite for MBS or PPC students, co-requisite for PPM students: ALS 331 Additional co-requisite (or pre-requisite if taken in prior year): ALS 429
Topics Covered
Course Schedule
Introductory meeting and analytical methods
Lab safety, organization, and appropriate behavior
Assay attributes: precision, accuracy, specificity, linearity, range, robustness Laboratory exercise in analytical methods: antibody quantity and purity
Unit operations in bioseparations, part 1
Chromatography
Laboratory exercise in protein A capture chromatography of antibodies
Unit operations in bioseparations, part 2
Cross-flow filtration
Laboratory exercise in cross-flow ultrafiltration and diafiltration of antibodies
Learning Objectives
· an understanding of lab safety, organization, and appropriate behavior
· the ability to determine assay attributes and use various assays for key bioseparations measurements
· an understanding of the many unit operations employed in bioseparations, including first-hand laboratory experience with some of the most common ones used in biopharmaceutical manufacturing, including Protein A capture chromatography and cross flow ultrafiltration/diafiltration.
· a basic working knowledge of GE Unicorn software, for control and operation of the GE Akta Pilot and Akta Cross Flow pilot systems used for the course
· an understanding of the various upstream and downstream processing options for monoclonal antibodies
· the ability to thoroughly analyze experimental bioseparations results, present the data graphically, and interpret the results with appropriate statistical analyses
Grading
Laboratory exercises, reports, participation, and behavior: 100%
Grading standard
This course is specifically designed for Bioprocessing focus track students. At certain times, it requires many hours of intensive laboratory work. A high level of dedication and performance is expected and is the norm. Most students receive a grade of A- or higher.
Required Texts