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Bioengineering in the Biotechnology and Pharmaceutical Industries:
Fundamental and Real World Perspectives
Course Number: 16:155:532 (CBE) Index Number: 75104 (CBE)
Course Number: 16:125:575 (BME) Index Number: 75115 (BME)
Time: Tuesdays, 5:00pm-8:00pm
Location: BME-116 |
DESCRIPTION AND OBJECTIVES
The goal of this course is to offer students insight into the practical aspects of industrial bioprocessing. Industrial practitioners from various fields of expertise provide lectures and facilitate discussions highlighting problems and issues that engineers and scientists encounter. Topics will vary from year to year but will include: drug discovery, drug metabolism, microbial fermentation and mammalian cell culture optimization and scale-up, monoclonal antibody, vaccine and gene therapy production, downstream purification, drug delivery, formulation, regenerative medicine, stem cell culture, tissue engineering, cellular therapies, regulatory considerations, manufacturing challenges, and clinical research. This course provides students with exposure to topics which are beyond the scope of a purely theoretically-structured course. After taking this course, students should have a better understanding of the challenges that engineers and scientists face in industrial bioprocessing. |
| Topics, Spring 2010 |
| Jan 23: |
(A) Introduction to Course Objectives and Topics - Gregory Russotti, Celgene Cellular Therapeutics
(B) Overview of Monoclonal Antibody Process Development – Bruno Marques, Merck Research Laboratories |
| Jan 30: |
Mammalian Cell Culture Scale-Up for Monoclonal Antibody Production - Gregory Russotti, Celgene Cellular Therapeutics |
| Feb 6: |
PEGylation of Proteins—Modification of Pharmacokinetic Properties - Eugene Schaefer, Bristol-Myers Squibb |
| Feb 13: |
Cell Line Development for Monoclonal Antibody Production - Kambiz Shekdar, Chromocell Corp. |
| Feb 20: |
DNA Vaccines Product Development—From the Bench to the Clinic – Niranjan Sardesai, VGX Pharmaceuticals |
| Feb 27: |
Large-Scale Bioreactor Design and Application - Ernie Stadler, Sartorius Stedim Biotech |
| Mar 5: |
Recovery Process Development and Validation for a Therapeutic Monoclonal Antibody - Bill Wang, MedImmune |
| Mar 12: |
Live Virus Vaccine Process Development - Gregory Russotti, Celgene Cellular Therapeutics |
| Mar 19: |
SPRING BREAK |
| Mar 26: |
Technology Transfer of a Biological Product from R&D to Manufacturing - Gregory Russotti, Celgene Cellular Therapeutics
PLEASE NOTE: Speaker, reading material and assignment has changed. Please look at Session and Speaker Info for current Speaker and assignment. |
| Apr 2: |
Technology Evaluation and Process Development Strategy for the Production of Therapeutic Proteins - Marco A. Cacciuttolo, Percivia |
| Apr 9: |
Challenges and Strategies in Cell Therapy and Tissue Engineering Bioprocess Development – Melvin Silberklang, Forticell Bioscience |
| Apr 16: |
Standard Oil and the Vertically Integrated Pharma Model: Repeating History - Robert Zivin, Johnson & Johnson |
| Apr 23: |
Cellular Therapeutics: Accomplishments, Promises, and Challenges – Tom Brieva, Celgene Cellular Therapeutics |
| Apr 30: |
Development and Commercialization of a Regenerative Tissue Matrix for Soft Tissue Repair and Replacement – David McQuillan, LifeCell Corp. |
Course Directors:
Gregory Russotti, Ph.D.
Director, Cellular Process Development
Celgene Cellular Therapeutics
732-564-3462
grussotti@celgene.com
Bruno Marques, Ph.D.
Investigator
Biopharmaceutical Development, GlaxoSmithKline
610-270-7024
bruno.marques@gsk.com
Dr. Martin Yarmush, M.D., Ph.D.
Professor, Department of Biomedical Engineering
Rutgers University
732-445-4500 x 6203
kma@soemail.rutgers.edu |
Grading:
30% Class Participation
• Participation in class exercises
• Homework and class participation should demonstrate adequate preparation for class
by thoroughly reading and critically thinking about the reading assignments
30% Homework Assignment
• Question on reading due at beginning of each class
• To be answered in ~ One page
• Typed or neatly handwritten answer
• HW grading criteria
40% Research Paper
• A critical assessment of the literature on a topic of your choice related to this class
• More details and example topics to follow |
Class Preparation:
Reading material can be found on course website for each week’s topic
Session and Speaker Info
- Class not recommended if you expect to miss >1 class
- You must notify Dr. Marques in advance if you will miss class and you must
submit answer to question on the reading
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