Bioprocessing

Bioprocessing makes use of microorganisms, cells in culture or enzymes to manufacture products. Humans have been using such processes for baking bread, making cheese and fermenting alcoholic beverages since prehistoric times. Advances in recombinant DNA technology allow the production of an enormous variety of protein-based therapeutics that are having a profound impact on the quality of life for severely ill patients. Bioprocessing is also key to several emerging industries and technologies, including the production of renewable biofuels such as ethanol and biodiesel, therapeutic stem cells, gene therapy vectors, and new vaccines. The Food and Drug Administration imposes stringent regulations on bioprocessing in the biotech industry; this highly regulated environment has an enormous impact on plant operations and product manufacture.

Students in the Bioprocessing focus area will obtain a thorough understanding of industrial processes from early-stage development through large-scale manufacture.

Career Options
Bioprocess Engineering
Process Development
Manufacturing Operations
Quality Assurance/Compliance
Regulatory Affairs (cGMP)
Project Management
Environmental Remediation
Food Technology
Therapeutic Stem Cells
Development and Manufacture of Gene Therapy Vectors and Vaccines
Development and Production of Renewable Biofuels
New Enterprise Development

Topics in the Curriculum
Bioprocess Engineering Fundamentals
Bioprocess Design and Economics
Unit Operations and Process Flow Diagrams
Bioprocess Operations Management
Bioreactor Design and Operations
Microbial Fermentation
Mammalian and Stem Cell Culture
Bioseparations
Bioprocess Development & Scale-up
Current Good Manufacturing Practices (cGMPs)
Standard Operating Procedures (SOPs)
Recombinant Protein Production
Protein Recovery, Purification and Analysis
Beer and Wine Fermentation
Viral Vaccines and Gene Therapy Vector Production
Renewable Biofuels Production

Course Offerings for the Bioprocessing Career Focus Track

Technical Courses
Four units of technical courses over both semesters are required for the Bioprocessing track. Two units must come from the required courses, ALS 427, 421, 429 and 422. The two additional units may come from any combination of courses in the following list.

Required
ALS 427 Mammalian Cell Biotechnology (1/2 course)
ALS 421 Mammalian Cell Biotechnology Laboratory (1/2 course)
ALS 429 Bioseparations Science and Engineering (1/2 course)
ALS 422 Bioseparations Science and Engineering Laboratory (1/2 course)

Additional Technical Options
ALS 428 Bioprocessing Research (1/2 course)
ALS 401 Biopharma: Biotechnology-based Therapeutics
ALS 403 Downstream Processing of Biopharmaceuticals (1/2 course)
ALS 407 Pharmacogenetics (1/2 course)
ALS 408 Advanced In Vitro Diagnostics
ALS 409 High Throughput Technologies (1/2 course)
ALS 412 Computational Biology for Drug Discovery (1/2 course)
ALS 420 Advanced BioInstrumentation Laboratory
ALS 425 Instruments: From Product Definition to cGMP Manufacturing
ALS 426 Medical Device Development and Market Release (1/2 course)
ALS 433 Clinical Trials Design, Conduct and Management (1/2 course)
ALS 434 Clinical Biostatistics (1/2 course)
ALS 435 U.S. Regulatory Affairs
ALS 437 Introduction to Clinical Pharmacology I (1/2 course)
ALS 438 Introduction to Clinical Pharmacology II (1/2 course)

Business Courses
Students may choose any combination of courses from the following list so that they have taken a total of at least two units over both semesters.
ALS 452 Applied Entrepreneurship Practicum* (1/2 course)
ALS 454 International Business and Global Health
ALS 455 Building a Biomedical Enterprise
ALS 456 Managing Strategic Networks
ALS 458 Applied Entrepreneurship**
ALS 459 Project Management (1/2 course)

*ALS 452 may count as a business/management course only with permission of the faculty instructor.
**ALS 458 begins in October and continues through March for a total of one course unit.