Biologics Manufacturing (Gr. Cert.) (15 credits)
Offered by: Bioengineering (Faculty of Engineering)
Program credit weight: 15-16
Program Description
The Graduate Certificate in Biologics Manufacturing focuses on the life sciences, the physical sciences, engineering, industrial practices and process sciences, regulatory requirements for biologics and data science for application in the sector of biologics manufacturing driven by the concept manufacturing 4.0.
Required Courses (12 credits)
| Course | Title | Credits |
|---|---|---|
| BIEN 590 | Cell Culture Engineering. | 3 |
Cell Culture Engineering. Terms offered: Fall 2025, Winter 2026 Basic principles of cell culture engineering, cell line development and cell culture products; genomics, proteomics and post-translational modifications; elements of cell physiology for medium design and bioprocessing; bioreactor design, scale-up for animal cell culture and single use equipment; challenges in downstream processing of cell-culture derived products; process intensification: fed-batch, feeding strategies and continuous manufacturing; scale-down and process modeling; Process Analytical technologies and Quality by Design (QbD) concept. | ||
| BIEN 601 | cGMP and Regulation in Biomanufacturing. | 3 |
cGMP and Regulation in Biomanufacturing. Terms offered: Fall 2025 Introduction to pillars of current good manufacturing practices (cGMP) in biologics, terminologies, and background; importance of cGMP for biologics manufacturing; principles of design and operation of cGMP facilities; knowledge gap between industrial processes and lab practices on GMP. | ||
| BIEN 670 | Downstream Processing . | 3 |
Downstream Processing . Terms offered: Fall 2025 Introduction to downstream processing (DSP) – principles, characteristics, purpose. Bioprocesses, biomolecules, drug substances, drug products, monoclonal antibodies and Fc fusion proteins, viral vectors, and vaccines. Unit operations - standard practices. Steps and techniques in downstream processing. Harvest and Filtration, Primary capture, Buffer exchange and up-concentration, Purification, Bioconjugation, Formulation. Optimization of downstream processing. Process Analytical Technology (PAT) to support Quality by Design (QbD) in DSP. Regulatory guidelines. Innovative Techniques for Downstream Bioprocessing. | ||
| BIEN 675 | Process Analytical Technologies and Data Sciences . | 3 |
Process Analytical Technologies and Data Sciences . Terms offered: Fall 2025 Introduction to Process Analytical Technologies (PAT) and Quality by Design (QbD) in the area of manufacturing biologics. Critical Process Parameters (CPP) and Design Space. Analytical Technologies for Biologics and Biologic Medicines and determination of Critical Quality Attributes of products. Case studies. At-line, On-line and Off-line monitoring tools, data acquisition and advanced process control strategies as applied to current industrial biomanufacturing. PAT data processing and modeling to design advanced biomanufacturing processes. | ||
Complementary Courses (3-4 credits)
3 or 4 credits from the following:
| Course | Title | Credits |
|---|---|---|
| BIEN 602 | Biomanufacturing for RNA Biologics . | 3 |
Biomanufacturing for RNA Biologics . Terms offered: Winter 2026 Fundamental and quantitative overview of RNA biologics. Introduction to RNA biologics associated biomanufacturing unit operations in upstream (design tools and large-scale production systems of DNA templates for in vitro RNA transcription; small-scale and large-scale RNA bioprocessing systems), and downstream approaches for RNA purification (like Tangential flow filtration and RNA-specific chromatography systems) for emerging mRNA therapeutics. Introduction to established and emerging applications of RNA biologics for gene and cell therapy. | ||
| BIEN 680 | Bioprocessing of Vaccines. | 4 |
Bioprocessing of Vaccines. Terms offered: Winter 2026 Building on recent developments and expansion in the mammalian cell culture for production of complex biologics such as viral vaccines and viral vectors, the following topics will be covered: Principles of immunology and industrial virology; Cell physiology for vaccine production; Cell lines for vaccine production; Upstream process development and process intensification strategies; Purification and downstream processing of viral vaccines; Analytical and potency assays; Formulations and delivery of vaccines; Basics of clinical trials and regulatory principles; Immunization policies. Case studies on bioprocessing/manufacturing licensed vaccines. | ||
| BIEN 685 | Gene and Cell Therapy Viral Vectors Biomanufacturing. | 3 |
Gene and Cell Therapy Viral Vectors Biomanufacturing. Terms offered: Winter 2026 Basic knowledge in the design and biomanufacturing of viral vectors for gene and cell therapy interventions. Practical examples and case studies highlighting challenges and solutions associated with use of viral vectors such as Adeno-Associated Vectors (AAV), lentivirus vectors and Adenovirus vectors for gene delivery. Fundamental principles of gene and cell therapies through in-vivo and ex-vivo interventions. Design of AAV, Lentivirus and Adenovirus vectors: example of targeted diseases, including CAR-T cell therapy. Technologies and modes of vector manufacturing for clinical use. | ||
| CHEE 512 | Stem Cell Bioprocess Engineering. | 3 |
Stem Cell Bioprocess Engineering. Terms offered: Winter 2026 Introduction to stem cell biology. Cell growth models applicable to stem cells and their progeny. Upstream processing (cell culture systems, bioreactors), downstream processing (cell separation, purification) and quality management (current good manufacturing practice, regulations) applied to therapeutic cells. | ||
| CHEE 651 | Advanced Biochemical Engineering. | 4 |
Advanced Biochemical Engineering. Terms offered: this course is not currently offered. The use of chemical engineering and biological principles in the study, design, use and creation of biologically-based processes and products. Topics: biochemical thermodynamics, protein engineering, manipulation of gene expression, transport phenomena and bioreactor design. | ||