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Theory. Experience. Internship.

MASTER’S IN BIOMANUFACTURING AND BIOPROCESSING

This innovative one-year master’s 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’s in Biomanufacturing and Bioprocessing Required Courses

Mammalian Cell Culture

Mammalian cell culture technology is about maintaining cells in vitro under controlled conditions for research or biologics production purposes. In recent decades, this technology has advanced significantly and these cells are used in variety of application. As a student in the class you will be exposed to the different methodologies utilized to grow cells and how this technology is becoming critical in production of many of the health care products used to control human diseases. The course will be divided into four general sections:

  1. Basic techniques for culturing and sub-culturing mammalian cells and growth parameters
  2. Quality control of a cell culture laboratory – How to control contamination.
  3. Primary cell culture and development of cell lines
  4. Scale-up of cell culture from a T-Flasks/Spinner Flasks to a bioreactor

Biomanufacturing and Bioanalysis I: Microbial Biopharmaceuticals

Biomanufacturing and Bioanalysis I will serve to introduce students to downstream bioprocessing principles, techniques, and analyses related to the purification of microbial biologics. Pharmaceutical manufacturing requires both quality control (QC) monitoring and knowledge of analytical techniques to ensure product purity, identity, and safety. This course will combine lecture discussion of major analytical methods used in the purification of microbial biologics with hands-on laboratory training in core techniques (i.e. chromatography, photometry, spectroscopy, bioanalysis). Upon completion of the course, students will demonstrate the ability to work in a GMP facility.

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.

Microbial Fermentation

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.

Pharmaceutical Microbiology

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.

Protein Chemistry and Protein Analysis

This course will provide a comprehensive overview of current approaches used for global-scale transcriptomic, proteomic and metabolomic analyses with focus on applications in drug discovery and development. Topics such as mass spectrometry-based biomolecular structure analysis, biomolecule separation/fractionation techniques, chemical and metabolic labeling approaches for quantitative analysis, and bioinformatic tools for interpretation of “omic” data sets will be covered. The goal of the course is to provide the student with the foundation necessary to understand the technical details of omics-based experimental design as well as to analyze and interpret large-scale data sets for a variety of drug discovery and development applications.

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.

Introduction to Regulatory Science

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.

Capstone Project

The capstone course will serve as a culminating part of the Master’s in 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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