Theory. Experience. Internship.
MASTER OF BIOMANUFACTURING AND BIOPROCESSING
This innovative one-year master program combines a foundation in bioprocessing and biomanufacturing theory, with experiential learning at CBET. Students will develop and run live bioprocessing projects from start to finish, using industry-standard equipment in a simulated cGMP (current good manufacturing practices) environment.
Following successful completion of their course work and laboratory requirements, students will complete an internship with one of CBET’s biopharmaceutical industry partners.
Offered with a flexible lecture and laboratory schedule, this Master’s is designed for early and mid-career professionals who want to enter the biopharmaceutical industry in a range of capacities, including cell-line development, process development, regulatory compliance, quality assurance/quality control, manufacturing and business development.
Master of Biomanufacturing and Bioprocessing Required Courses
Mammalian Cell Culture
Mammalian cell culture technology has been routinely employed for research, drug discovery, and biomanufacturing of biological products. The Mammalian Cell Culture Course focuses on applications of mammalian cells in the biomanufacturing of value-added products. The course will serve to introduce the students to (1) overview and applications of mammalian cell culture technology, (2) aseptic techniques and the importance of lab safety and biosafety, (3) cell culture essential techniques, (4) biology and characteristics of cells in culture, (5) cell-line development and metabolic engineering principles, (6) cell culture media design, preparation, and optimization strategies, (7) upstream analytics, (8) scale-up and bioreactors, and (9) regulatory guidelines. Students will learn to subculture/passage both adherent and suspension mammalian cells. Students learn adherent cell culture in T-flasks and microcarrier bead technology. Students learn suspension cell culture in shake flasks, spinner flasks, and stir-tank bioreactors. The Mammalian Cell Culture Course is a lab-intensive lecture and discussion-based course. Students learn through active learning activities, such as lab-based experiments, case studies, presentations, and group debates. Upon completion of this course, students will learn the principles and applications of mammalian cells and the utilization of mammalian cells for the biomanufacturing of safe and effective products.
Downstream Processing of Biopharmaceuticals
This course will serve to introduce students to downstream bioprocessing principles and technologies used in the industry for purification of microbial and mammalian biologics along with supporting QC/QA techniques and analyses related to the biopharmaceutical manufacturing to ensure product purity, identity, and safety. This course will combine lecture discussion of major steps for cell disruption, separation, purification, and formulation technologies (homogenization, centrifugation, filtration, chromatography, TFF) used in the purification of biologics with hands-on laboratory training and also core techniques i.e., electrophoresis, glycan analysis, functional assays, chromatography, and cell-based assays. Upon completion of the course, students will demonstrate the ability to understand how biopharmaceuticals are purified and certified safe and effective.
Pharmaceutical and Biopharmaceuticals Industry Entrepreneurship
This course will provide an overview of the industry covering topics of: research, development, medical, regulatory, marketing, sales, distribution, legal, ethics and compliance. Headquarters and field based perspectives will be shared. The course will provide the student with an overview of the various types of careers available within the industry. The course will be team taught by industry experts.
Statistical Inference and Modeling
This course provides students with a basic knowledge of biostatistics. It includes methods of experimental design and data analysis used to make inference. Topics covered include confidence intervals, hypothesis testing, multivariable regression, generalized linear models, survival models and analysis of variance. The course will also include a component which introduces the students to statistical programming.
Ethics in Research
This course includes a discussion format based on ethical issues involved in the research process. Students will have focused reading on the ethical issues involved in research and then will apply the readings to case studies during discussion. Topics covered will include, but are not limited to: morality and research ethics, ethical issues before research committees, ethical issues involving human and animal subjects, reporting of research and conflict of interest.
This lecture/laboratory course builds upon the scientific knowledge underlying the principles (for example fluid flow, mass transfer, heat transfer, and the energy relationship of fluid systems) of fermentation technology to design, develop, and optimize key parameters in a biomanufacturing process. Topics includes the optimization of media composition, fermenter and bioreactor design, the strain and host selection, instrumentation, and process analytical tools to maximize the yield and integrity of a protein pharmaceutical.
This course will introduce the principles of microbiology as applied to manufacturing aspects of pharmaceutical industry. It will cover a wide range of topics including the nature of micro-organisms, contamination sources and control, sterilization and disinfection, and sterility testing methodologies. Antimicrobial agents, their modes of action and mechanisms of drug resistance will be discussed in detail. The students will also acquire knowledge of various microbiological assays and evaluation methods of antimicrobials. Drug designing and regulatory requirements for conducting clinical trials will be discussed. Good Manufacturing Practices (GMP), Quality Control (QC), and Quality assurance (QA) in the manufacturing processes of pharmaceuticals based on current regulatory requirements will also be discussed.
Clinical Biochemistry is foundational to medical science and will help students develop an understanding of biological molecules and their relationship to common disorders. Using applications and clinical correlations, the course will reinforce the role of enzymes as building blocks of life and in catalyzing and regulating biochemical reactions within the body. The integration of various metabolic pathways, cellular metabolism, and biosynthesis with emphasis on the key concepts of structure and function of macromolecules involved in physiological processes will serve as the basis for an understanding of drug action and drug development. Biomolecular techniques related to clinical analysis will also be explored. This course will combine lecture discussion and assignments designed to enhance student learning. Upon the completion of this course, students will learn the applications and clinical implications of human biochemistry, the cellular basis for several common genetic diseases and metabolic disorders, and essential techniques related to clinical biochemistry.
Technical Writing for Biopharmaceutical Industry
The course is an advanced study in technical writing with a focus on writing for the biopharmaceutical industry. The course will provide information on various forms of writing documents in the industry including memos, proposals, formal and informal reports, Standard Operating Procedures (SOPs), batch documents, facility and environmental monitoring reports, validation reports and protocols. Regulatory requirements along with examples of documents reviewed by regulatory bodies will also be discussed. Emphasis is on understanding the differences between scientific and technical writing, including techniques for organizing, evaluating, and presenting information. Instruction will include writing as a process, from researching a problem to organizing and drafting a document to testing, revising and editing that document.
Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of products, according to the definition by US FDA. The course begins with introducing the history and current status of the US federal regulatory system and the FDA. As the course progresses, emphasis will be placed on the structures and outcome of the law, regulatory strategies, globalization issues and ethics dilemmas of this emerging field, using cases and discussion to engage active learning.
The capstone course will serve as a culminating part of the Master of Biomanufacturing and Bioprocessing degree program. It will require the production of a peer-reviewed, journal article quality, written document. The document (25-40 pages) will either be 1) a major literature review on an existing scientific topic that is relevant to the student’s field of study or 2) based on a no-credit experiential learning experience such as a co-op, internship, or lab research.
Upon completion of the course, the student will demonstrate the ability to understand, synthesize and analyze a complex industrial/scientific topic using critical thinking skills, evaluating possible outcomes and clearly presenting sound scientific conclusions. Students will be required to orally present and successfully defend their final capstone report for committee review.
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