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).

Credits

1

Prerequisite

BIO-287

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

• Spring

Course Learning Outcomes

1. Demonstrate their understanding of the roles of Quality Assurance and Quality Control in a GMP environment
2. Use basic analytical tools in a manufacturing environment (RCA and FMEA)
3. Apply regulatory affairs introduced in part I of the course
4. Follow proper documentation procedures as outlined in the Good Laboratory and Good Manufacturing Practices (Food and Drug Administration)
5. Demonstrate sterile gowning technique to an industry standard
6. Apply Root Cause Analysis tools to solve problems

View Course Outline

BIO 288: Introduction to Biomanufacturing II

Department

Science and Technology

Course Description

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).

Credit Hours

1

Contact Hours

Lecture	0.5
Lab	1
Other	0

Grading Scheme

Letter

Semester(s) Course Will Be Offered

Spring

Prerequisites

BIO-287

First Year Experience Course

No

Capstone Course

No

Course Learning Outcomes

1. Demonstrate their understanding of the roles of Quality Assurance and Quality Control in a GMP environment
2. Use basic analytical tools in a manufacturing environment (RCA and FMEA)
3. Apply regulatory affairs introduced in part I of the course
4. Follow proper documentation procedures as outlined in the Good Laboratory and Good Manufacturing Practices (Food and Drug Administration)
5. Demonstrate sterile gowning technique to an industry standard
6. Apply Root Cause Analysis tools to solve problems

Topic Outline

1. Critical Thinking Skills
   1. Root Cause Analysis (RCA) and RCA tools
   2. Failure Mode and Effects Analysis (FMEA)
   3. Corrective and Preventative Action Plans
   4. Industry-specific safety regulations
2. Safety and Permitting
   1. Confined Space Entry
      1. Permitting
      2. Confined space Evaluation
   2. LOTO
   3. HAZCOM Programs
      1. Safety Audits
      2. Labeling and MSDS
3. Quality in Biomanufacturing
   1. Quality Control
   2. Quality Assurance
   3. Material Control
   4. Popcorn GMP Laboratory
   5. Batch Records
4. Regulatory Affairs and Bioethics
   1. cGMP
      1. Adherence to 21 CFR Part 211 - Drugs
      2. Adherence to 21 CFR Part 117 - Food
   2. FDA inspections and FDA letters
   3. Clinical trials
5. Upstream processing
   1. Sterile technique
   2. Sterile Inoculations
   3. Media preparation and sterilization
   4. Bioreactors and bioreactor assembly
6. Downstream processing
   1. Bioreactor decommissioning
   2. Media processing
   3. Centrifugation and filtration
7. Industry tour (off-campus)