BIO-287 Introduction to Biomanufacturing I

Students in the Introduction to Biomanufacturing I course will learn how a biopharmaceutical makes its way from "bench to bottle." Upstream and downstream manufacturing processes will be introduced through a combination of lecture and laboratory (hands-on) activities. Students will be introduced to regulatory affairs and will follow proper documentation procedures as outlined in the Good Laboratory and Good Manufacturing Practices (Food and Drug Administration).

Credits

1

Prerequisite

BIO 121 General Biology I

Lecture Contact Hours

0.5

Lab Contact Hours

1

Other Contact Hours

0

Department

• Science & Technology

Grading Scheme

• Letter

SUNY Gen Ed Credit

• No

Semesters Course Will Be Offered

• Fall

Course Learning Outcomes

1. Demonstrate their understanding of the steps required to bring a biopharmaceutical product to market
2. Describe the upstream and downstream steps involved in the manufacturing of a biopharmaceutical.
3. Follow Good Manufacturing and Good Laboratory practices when performing laboratory tasks.
4. Use chromatographic methods to separate proteins.
5. Write a Standard Operating Procedure (SOP) that meets industry standards

View Course Outline

BIO 287: Introduction to Biomanufacturing I

Department

Science and Technology

Course Description

Students in the Introduction to Biomanufacturing I course will learn how a biopharmaceutical makes its way from "bench to bottle." Upstream and downstream manufacturing processes will be introduced through a combination of lecture and laboratory (hands-on) activities. Students will be introduced to regulatory affairs and will follow proper documentation procedures as outlined in the Good Laboratory and Good Manufacturing Practices (Food and Drug Administration).

Credit Hours

1

Contact Hours

Lecture	0.5
Lab	1
Other	0

Grading Scheme

Letter

Semester(s) Course Will Be Offered

Fall

Prerequisites

BIO 121 General Biology I

First Year Experience Course

No

Capstone Course

No

Course Learning Outcomes

1. Demonstrate their understanding of the steps required to bring a biopharmaceutical product to market
2. Describe the upstream and downstream steps involved in the manufacturing of a biopharmaceutical.
3. Follow Good Manufacturing and Good Laboratory practices when performing laboratory tasks.
4. Use chromatographic methods to separate proteins.
5. Write a Standard Operating Procedure (SOP) that meets industry standards

Topic Outline

1. Drug Development Process and Regulatory Affairs
   1. Safety and Lab orientation
   2. Introduction to the FDA and regulatory affairs
      1. History of the FDA and CDER/CBER
      2. cGMP
      3. GLP
      4. OSHA
      5. EPA
   3. The drug development process
      1. Pre-clinical
      2. Clinical Trials
      3. Post-market surveillance
      4. FDA applications (IND, BLA, NDA)
   4. The laboratory notebook
   5. Intro to methods of protein purification
2. Bioinformatics
   1. Theory: Protein chemistry
   2. Theory: Protein separations
   3. Bioinformatics and Databases
      1. BLAST searches and output interpretation
      2. Database management
3. Cloning and scale-up (production systems)
   1. Theory: Recombinant DNA technology
   2. Aseptic techniques and awareness
   3. Biosafety cabinet cleaning and operation
   4. Streaking plates (cloning)
   5. Scale-up, primary cultures
4. Buffer and media preparation
   1. Labeling and documentation procedures for solution preparation
   2. Solution and dilution calculations
   3. Buffer preparation (chromatography solutions)
      1. Ammonium sulfate dilutions series for HIC
      2. Tris Buffer / NaCl solutions for IEX
      3. NaCl solutions for SEC
   4. Writing and Evaluating SOPs, deviations, revisions
5. Downstream Processing: Protein Purification
   1. Process development: designing a purification strategy
   2. Ion Exchange Chromatography (IEX)
   3. Size Exclusion Chromatography (SEC)
   4. Hydrophobic Interaction Chromatography (HIC)
6. Quality Control
   1. Theory: Quality control
   2. QC testing with SDS-PAGE electrophoresis
   3. Process Development: Troubleshooting