Coursework in the MBS curriculum allows students to achieve depth in an area that closely follows a specific industry career path. KGI’s concentrations provide in-depth knowledge of specific functional areas of the bioscience industry. Each specialized program offers participation in real-world industry experiences and interaction with industry leaders coupled with a cutting-edge curriculum taught by faculty with extensive industry experience.

MBS Concentrations

  • Program Director: KiriLynn Svay

    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.

    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
  • Early career professionals possessing a combination of science and engineering expertise and business acumen function as highly-valued bridges between scientific discovery and business activities in bioscience companies. Keck Graduate Institute’s Master of Business and Science program provides excellent preparation for management careers in the bioscience industry as science and engineering concepts are integrated with management and industry issues.

    Topics in the Curriculum

    • Entrepreneurship
    • Sources of Innovation
    • Commercialization Strategy
    • Value Chain Dynamics
    • Drug Pricing and Reimbursement
    • International Business
    • Emerging Market Biotech Strategies
    • Accounting and Finance
    • Venture Capital Financing
    • The Role of the CEO and Corporate Culture
    • Stages of Firm Growth
    • Mergers and Acquisitions
    • Sales and Marketing
    • Operations: Balancing Control and Innovation
    • Managing Human Resources
    • Modeling Revenues, Market Shares & Expenses
    • How to Write a Business Plan
    • Intellectual Property and Licensing
    • IPOs
  • Every drug, diagnostic test and medical device sold in the United States must meet a rigorous set of criteria to ensure quality and performance requirements. These standards are imposed by federal law and overseen by the Food and Drug Administration. Similar agencies regulate new product approvals in other countries. Although the process can be lengthy and expensive, patients needing medications and devices are relatively certain they are receiving safe, effective products of reliable quality. FDA monitoring continues even after these products have been approved for sale insuring that as more people use the product, issues such as appearance of rare side effects will be understood.

    Topics in the Curriculum

    • Clinical Development: Phases 1-3 Studies
    • Accelerated Drug Approvals, Accessibility Programs
    • Biostatistics
    • Small Molecule Formulation
    • Clinical Trials Design
    • Drug Delivery Systems
    • Drug Master Files (DMF)
    • Good Clinical Practices (GCP)
    • Investigational New Drug Application (IND)
    • Common Technical Document (CTD)
    • Labeling, Packaging and Advertising
    • New Drug Application (NDA)
    • Post-approval Changes, Phase 4 Studies
    • Action letters and Pre-Approval Inspections (PAI)
    • Orphan Drug Development Program
    • International Regulatory Affairs
    • Standard Operating Procedures (SOPs)
  • Program Director: Anna Iwaniec Hickerson

    The demand for new and improved devices is increasing as our population ages and new technologies generate treatments that were unimaginable only a few years ago. New diagnostics are allowing earlier, more sensitive, less invasive and less expensive detection and monitoring of a wide variety of diseases and conditions. The design and manufacture of biomedical devices and diagnostics benefits from an interdisciplinary approach that draws on engineering, chemistry, physiology, medicine and computer science. Professionals who attain this interdisciplinary knowledge and who also understand the business and regulatory issues involved in bringing new devices and diagnostics to market are in high demand in this industry.

    Topics in the Curriculum

    • Biomarkers: discovery and validation
    • Assay development: analytical & clinical validation
    • Biomolecular recognition / nucleic acid hybridization
    • Enzymes in clinical and molecular diagnostics
    • Flow cytometry
    • Immunoassays
    • Clinical chemistry
    • Molecular diagnostics
    • Pharmacogenomics
    • Histology and cytology
    • Hematology, coagulation
    • Diabetes monitoring
    • Microfluidic technologies
    • Point-of-care diagnostics
    • Vital sign monitoring
    • Cardiovascular devices
    • Implantable prosthetics
    • Medical Imaging
    • Product development stages and process
    • COTS component functionality, specifications, and pricing
    • Prototyping Processes
    • Manufacturing Processes
    • Design for Manufacture and Assembly
    • Medical device and diagnostic regulations
    • Clinical trial phases, elements, and strategies
  • Program Director: Anastasia Levitin

    This concentration prepares students for careers as pharmaceutical scientists in areas of therapeutics discovery, development and commercialization. Pharmaceutical and biotechnology industries are complex and constantly evolving and require diversity of expertise. The goal of this program is to expose students to multiple facets of therapeutics discovery and development. The curriculum has been designed to cover major aspects involved in discovery, development and commercialization of the therapeutics while simultaneously providing the students with multiple options to pursue related areas of interest.

    New and established pharmaceutical companies spend years to translate new scientific discoveries into commercially available products. This translation process requires process development, pre-clinical development, clinical trials and manufacturing under FDA/EMA quality regulations. Successful commercialization also requires significant input throughout development from business development, sales, distribution and marketing in addition to preparations for product launch. These business processes require managers with strong organizational skills and the ability to span the business and technical domains to coordinate resources and deliver timely results.

    Topics in the Curriculum

    • Bioethics
    • Bioinformatics
    • Biomarkers
    • Biostatistics
    • Clinical Pharmacology
    • Clinical Trial Design
    • Drug discovery and testing
    • Economics of drug development
    • Good laboratory practice (GLP), Good clinical practice (GCP), and
    • Good manufacturing practice (GMP)
    • Government regulations and development process
    • Personalized medicine
    • Pharmaceutics and Biopharmaceutics
    • Pharmacogenetics, Kinetics, and Dynamics
    • Pharmacogenomics
    • Pre-clinical data analysis
    • Project management of cross functional teams during the
    • development process
    • Target validation