Master of Science in Biotechnology at Harrisburg University Course Descriptions

BTEC 502 Biomaterials

Description:  There is a constant need for new biomaterials in life sciences to support novel technologies. This course is designed to introduce students to the various classes of biomaterials currently in use and their application in selected subspecialties of medicine/industrial processes. Students will learn about the concepts behind developing materials for use in medical or industrial biotechnology field. They will gain an understanding of material properties, various biological responses to materials, and the clinical context of their use. Aspects of manufacturing processes, cost, sterilization, packaging, and regulatory issues will be addressed

BTEC 508 Omics for Life Sciences

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  At present studies on cataloging and characterization of genome and proteome are on forefront of research. Recently, there has been a lot of work happening with genome and proteome data for selective manipulation of metabolic pathways, the metabolomics. All three fields are aggressively used in several areas for innovation in diagnostics, biomanufacturing, biomarker studies, and drug discovery to name a few. This course covers the basics of these three “omics” fields from the standpoint of using the information for developing new biotechnologies, especially in personalized medicine. The significance of next generation sequencing will be covered

BTEC 522 Graduate BTEC Seminar

Description: This course will introduce students to fundamental topics in innovation, regulatory practices and ethics for various biotechnology industries /communities. The intention is to allow students to learn about these diverse but inter-related areas that coalesce science and business disciplines. With the help of industry experts, case studies, and current literature, students will explore the interrelationship of these areas for creating productive collaborations within biotechnology industry with respect to compliance, innovation, and ethical decision making.

BTEC 540 Biostatistics

Description:   This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions, population parameters and their sample estimates, descriptive statistics for central tendency and dispersion, hypothesis testing and confidence intervals for means, variances, and proportions, the chi-square statistic, categorical data analysis, linear correlation and regression model, and analysis of variance. The course provides students a foundation to evaluate information critically to support research objectives and product claims and to gain better understanding of statistical design of experimental trials for biological products/devices.

BTEC 550 Instrumentation in Biotechnology Industry

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:   Instrumentation and application of various equipment is central to research as well as commercial production in the biotechnology industry. This course will familiarize students with which instruments are used for which biotechnology applications and their principles of operation and limitations. Different biomolecules require different and customized protocols for isolation, purification, and characterization. The course will offer an overview of instruments such sonicator, ultracentrifuges, spectrophotometers, etc. The course will also cover the significance of instrument validation and calibration.

BTEC 560 Design of Experiment

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:   This course will allow students to design an experiment and learn methodology for data analysis. Components such as major characteristics of a scientific experiment, running statistical analyses to perform various tests to check validity of the data would be covered. In a case-based manner, each student would work on design of an experimental protocol for an assigned conceptual research project. Trouble shooting strategies and analyzing data sets would be covered.

BTEC 610 Advanced Topics in Drug Discovery and Delivery

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  This course introduces students to the planning and preparatory phase skills required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA regulations and guidelines. It is known that in drug discovery sector, it is important to plan before the proceeding to the development phase. With emphasis on the process, the course focuses on the final analysis and report before developing the protocols. Other important aspects of drug development covered in the course are preclinical investigations; new drug application (NDA) or biologic license application (BLA) format and content; clinical development plans; product and assay development; the Investigational New Drug (IND) process; and trial design, implementation, and management. Lastly, the course will provide an overview of trending concepts such as controlled and targeted drug delivery.

BTEC 612 Regulatory Affairs in Life Science Industry

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  Regulatory affairs (RA) are set of rules and regulations that oversee and govern product development as well as post-approval marketing in the life sciences.  For US companies, Food and Drug Administration (FDA) establishes and oversees the applicable regulations under several statutes, partnership with legislators, patients, and customers. The commercializable products for Biotechnology sector can be food, drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA, and its effect on product development. The course will cover RA history, various regulatory agencies, methods to access regulatory information, procedures for drug submissions, biologics submissions, and medical device submissions. It will also address Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA inspections and so on. The course will include guest lectures, actual case studies and real world scenarios. As a course project, students will create a conceptual submission document for a hypothetical drug/biologic/medical device approval.

BTEC 615 Biomedical Devices and Prototyping

Description:  The course goal is to familiarize students with basic principles of biosensors design and applications. Biomedical devices such as Biosensors are one of the most innovative, complex, and fast-growing area of biotechnology today—the interface between biotechnology, nanotechnology and micro-electronics industries. The course covers a variety of biosensors based on whole cells, nucleic acids, proteins, antibodies and enzymes as well as new and emerging technologies related to designing, fabricating, and applying multi-array biochips and micro-fluidic systems (lab-on-the-chip). The course will then cover practical applications of this technology in health care, environment, medical diagnostics, defense and other areas.

BTEC 618 Principles of Bioprocessing

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  Bioprocessing deals with the isolation, purification, and characterization of industrial bio-products. This course will prepare students, with skills needed in bioprocessing procedures used in industry. The course will cover fundamental scientific principles underlying the recovery, purification and formulation of biomolecules, especially proteins, or other industrial bio-products. Identification or delineation of key chemical and physical properties of biomolecules that impact downstream processing and formulation development will be emphasized. Introduction to analytical and small-scale purification procedures will expose students to key scientific principles and small scale unit operations.

BTEC 620 Emerging Trends In Diagnostics

Prerequisite:  BTEC 502

Description:  This course provides an overview of the fundamental principles of molecular diagnostics and explores the use of molecular techniques in the diagnosis of disease/infection/contaminants. Diagnostics has impacted several fields such as human health, environment, and food and agriculture. Development of novel diagnostics technologies have depended on discovery of biomarkers for multiple applications in fields such as drug discovery, drug delivery, and diagnostics in general. Topics to be covered in this course include: biomarkers, protein and nucleic acid structure-function, identification and amplification techniques used in infectious disease diagnosis, components of a molecular diagnostics, companion diagnostics, and evaluation of controls to validate results obtained.

This course allows innovative use of current literature and technology with an entrepreneurship element. Students will have an opportunity to use course material and available technology to design a conceptual assay/device for a chosen target and integrate it into a conceptual course project assignment.

BTEC 622 Principles of Accounting and Finance

Prerequisite:  Completion of 6 credits in the program.

Description:  This graduate course in general accounting and finance is offered to allow students gain basic introduction to principles of accounting and finance for the life science industry. Accounting and finance take different shades when one compares revenues for giants like Target with that for a pharma company. Students will learn about life science companies and their accounting processes. Impact of significant adjustments and estimates on revenue counting, health insurance, managed care, and governmental contracts and so on will be covered. Course will also cover accounting issues related to multi‐round private financing and IPO timing for start-ups. In the finance module, students will learn about the basics of money management, will become familiar with the language and vocabulary of finance, understand how to communicate scientific concepts to potential investors, and how to generate fiscal plans/milestones. Course activities will enable students to create/analyze financial documents such as a term sheet, a contract and a balance sheet. Students will also learn about the concepts of financial risk and the time value of money. The course will use real company scenarios and case studies from life sciences companies.

BTEC 625 Pharmacogenomics

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  The genetic basis of variability in drug response can contribute to drug efficacy and toxicity, adverse drug reactions, and drug-drug interactions. Healthcare professionals need an understanding of the genetic component of patient variability to deliver effective individualized pharmaceutical care. This course will offer introduction to the evolution of pharmacogenetics/pharmacogenomics, the human genome and modern applications of DNA information related to diagnostics, drugs and therapeutics. Emphasis will be placed on concepts and methodologies for using an individual’s genetic make-up in deciding that individual’s predisposition towards diseases and ability to respond to drugs. Understanding of the basics of pharmacogenomics will enable students to better understand and manage the new genomics based tools as they become available as well as make best treatment choices.

BTEC 630 Cancer Biotechnology

Description:  Cancer has a huge impact on our society and is one of the major factors driving biomedical research related to various areas such as imaging, diagnosis, and therapy. This course will provide a comprehensive overview of the molecular biology and genetic basis of cancer. Biotechnological research on the molecular mechanisms of cancer has resulted in more effective treatments, sensitive diagnostic procedures, and strategies for prevention. The course will cover topics such as mutations leading to deregulation of programmed cell death, their impact on cell proliferation, as well as cell differentiation. Additionally the course will review cancer and medical intervention. It will allow students to study traditional treatment methods as well as new treatment protocols for cancer therapies. The challenges for early diagnostics will also be covered.

BTEC 634 Healthcare Economics: Fundamentals for Providers and Biotech Industry

Description:  Patients, healthcare providers and biotech industry professionals all have an interest in the best possible medical care, but healthcare services and products come at a cost. This course explores economics of topics that impact the cost of healthcare as we know it today, and how the healthcare technologies of the future will be funded. Additional questions such as who pays and who gets access when healthcare is in limited supply will be discussed. Among the factors that will be explored are market dynamics, public policy, technology, reimbursements, and workforce and patient choices.  Case studies, course papers, and group discussions would be used to offer the course content in an engaging and interactive mode. This course requires no previous study of finance or economics.

BTEC 635 Clinical Pharmacology

Description:  Clinical pharmacology deals with drug development and drug utilization in therapeutics. This course will cover the advancements regarding drug action and efficacy. Concepts of pharmacokinetics, drug metabolism and transport, pharmacogenetics, assessment of drug effects, and drug therapy in special populations will be explored. The course will offer students expert knowledge about drug development and content specialization needed to stay competitive and build opportunity for career options.

BTEC 640 Trends in Regenerative Medicine

Description:  Tissue engineering (TE) and regenerative medicine (RM) are geared towards developing biological substitutes that restore, maintain, or improve damaged tissue and organ functionality. While tissue engineering and regenerative medicine have hinted at much promise in the last several decades, significant research is still required to provide exciting alternative materials to finally solve the numerous problems associated with traditional implants. The course will cover relevant biological, engineering, clinical, legal, regulatory and ethical principles and perspectives to understand the basics of RM. Students will learn about cell therapy, gene therapy and tissue engineering. Other topics to be covered are stem cells, artificial tissues/organs, cell-based immunotherapy, materials (nano) used and gene editing techniques such as a CRISPR/Cas-9, and Bio-printing (3D printing of biological tissues). The course will also introduce the students to the current state of the RM field, global market trends and opportunities, as well as challenges in process development, manufacturing, and commercialization.

BTEC 650 Fermentation Technologies

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  Fermentation technology focusses on use of recombinant microorganisms for several industrial processes i e biomanufacturing. This course will allow students will allow the students to conceptually design a process for biomanufacturing a target product. This will include basics of strain selection, development, and process optimization. Application of strain morphology, physiology and DNA sequence- based methods will be analyzed for industrial processes. Students will learn about microbial metabolism and its significance to the manufacturing process. Fundamentals of microbial growth, growth stoichiometry, types of growth media (defined, semi-defined, complex) and media optimization will be covered. The course will provide an overview of fermenter design concepts and operational principles for a fermentation process using bioreactors.

BTEC 655 Industrial Enzymes and Proteins

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  There is significant commercial activity in the biomanufacturing sector.  Key products include vaccines, antibiotics, or various industrial enzymes. This course will teach students the basics of recombinant DNA (rDNA) principles in modification, selection, and application of recombinant microbial strains for industrial enzyme and protein production. Students will specifically learn about theoretical foundations of microbial production and detection of recombinant protein products such as enzymes, hormones, and antibiotics. Course will provide an overview of basic methodologies involved in genetic manipulation of microbes to produce recombinant peptides and proteins. This would focus on use of plasmids, role of promoters and its use in control of gene expression with the end goal of generating enzymes and whole cells for industrial catalytic processes.

BTEC 672 Legal Affairs and Policies for Life Science Industry

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  This course provides students an overview of key legal concepts and policies that govern research, development and commercial activities within the biotech industry. This course is structured from a company’s perspective and will introduce students to issues and strategies critical to management while considering new topics/products. Selected cases, videos of talks, and assigned reading will illustrate how the laws that provide protection of society and promotion of social goals operate. Procedures that allow navigating the middle ground while dealing with competition in the biotech and pharma industry would be covered as well. Case studies, course papers, group discussions would be used to offer the course content in an engaging and interactive mode. This course requires no previous legal study.

BTEC 675 Innovation and Improvisation in Research and Development

Prerequisite:  Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor.

Description:  This course will offer students research and development sector. Students will develop creative problem-solving abilities and other skills necessary for innovative approaches in managing research and development units. Students will learn about resolution of conflicts between Research and Development, manufacturing, and marketing in a high technology firm. They will learn about coping strategies, ways to maintaining entrepreneurial spirit and encourage innovation as the company develops into a formal administrative organization, identify R &D issues and strategies to resolve them. They will learn about successful mass production techniques such as Just-In-Time, On-Job Training and Total Quality Management to the real world of high-technology Research & Development (R&D). AS a team project for the course, students will identify and develop solutions to practical problems or market needs for a hypothetical scenario. Journal discussions, case studies, and other modes would be used in the course.

BTEC 698 Biotechnology Graduate Internship

Prerequisite:  Completion of 6 credits in the program.

Description:  This graduate internship course provides students an opportunity to serve as a graduate intern and learn the skills of a certain job in real world situation. To get trained under supervision of an industry professional is an excellent opportunity for students, not only to learn the tricks of the trade but also to make professional connections. It will be the student responsibility to identify an industry or an organization from his/her field of interest and work on a mutually relevant topic under direct supervision of an employee from that company. The course will involve a plan for the internship, progress report and a detailed final report. The mode of engagement and timeline will be decided by the student in consultation with the agency personnel offering supervising the internship.