Biotechnology   

BTEC 675: Is a comprehensive study of the commercial practices used to deliver life science based products to the market. Having emerged less than 40 years ago, the modern biotechnology industry has developed into a dynamic and very diverse commercial segment spanning healthcare, agriculture and industrial applications. In many respects, it is unique compared to other industries. Commercial development timelines are considerable longer than other technology areas, manufacturing involves the use of highly complex processes, many of which are not well characterized or controlled, and products are subjected to demanding regulatory scrutiny. This course aims to introduce the student to the industry as an engine of innovation. The course uses a comprehensive text supplemented with primary literature and case studies. Subjects covered include the history of the industry, the current emerging technologies and the business techniques used to bring bioscience ideas to commercial fruition. Topic areas are: Company creation, technology assessment and commercialization, product development, manufacturing, market assessment and development, and financing.

This course is open to the general public-not limited to UMBC students.

BTEC 691: This course will be offered completely online in a synchronous format at the day/time listed The Analytical Techniques for Biopharmaceuticals course offers an in-depth exploration of the molecular and analytical techniques essential for the development of biologics and biopharmaceuticals. This course provides students with a comprehensive understanding of advanced molecular techniques such as PCR, qPCR, ddPCR, NGS, and RNA sequencing, focusing on their principles and applications in biologics development. Students will also explore immune-based methods, including ELISA, Western blotting, and IHC/ICC, which are critical for biologics research, particularly in antigen-antibody interactions. A key component of the course is learning how to assess the stability and potency of biologics, ensuring their effectiveness and safety over time. Additionally, students will gain a deep understanding of using -omics technologies for biomarker discovery and personalized medicine in biologics development, with a focus on cellular pathways. The course also covers advanced in vitro models, including 3D cell culture systems and other cutting-edge cell culture techniques, which are crucial for biologics testing and development. Students will further study biophysical characterization methods, including UV-Visible Spectroscopy, Dynamic Light Scattering, and Surface Plasmon Resonance, which are vital for the analysis of biologics. Additionally, the course includes essential microbiological testing for drug sterility and injection safety, teaching students how to ensure biologic products meet stringent safety and regulatory standards. Chromatography techniques, including HPLC, UPLC, SEC, and GC, will be covered for drug analysis, allowing students to understand how these methods are used to assess the purity, composition, and quality of biologic products. Finally, students will learn how to assess immunogenicity in biologics by detecting anti-drug antibodies and evaluating T-cell activation. By the end of the course, students will possess a robust set of skills and a deep understanding of advanced techniques in biologics research, crucial for careers in the biotechnology and biopharmaceutical industries.

This course is not limited to UMBC students and is open to the general public.

BTEC 654: This seminar-style, capstone course is an in-depth exploration of emerging technologies, innovations and new products that are noteworthy to the biotechnology industry. The first half of the course focuses on examining and critiquing what new scientific discoveries will likely impact the industry and in what ways. In the second half of the course, students, working in teams, will give written and oral presentations on case studies that attempt to predict products derived from the new innovations and discoveries. The objective of the course is to give the student insight into the process of translating scientific discovery into innovative products.

Enrollment Requirements: Prerequisite: BTEC 656, BTEC 660, BTEC 665, BTEC 670, and BTEC 675 

This course is open to the general public-not limited to UMBC students. 

BTEC 661: An overview and network connection basis concluding with a case study for each team to present on the dynamic and emerging field of Cell and Gene Therapies. Students will learn about all the new modalities, companies, techniques, and future approaches to treating serious diseases worldwide.

This course is open to the general public-not limited to UMBC students.

BTEC 668: This course introduces students to clinical trials research as it pertains to the development of a biotechnology product. Students will start by learning about the purpose of clinical trials, the clinical trial phases, pre-clinical trial activities, and key actors in the process. The remaining course will cover the primary elements of each phase, ethical and regulatory issues, and future trends. Students will gain a greater understanding of clinical trials for more productive engagement with such professionals in the biotechnology industry or to start on a path towards a career in clinical trials research.

This course is open to the general public-not limited to UMBC students.

BTEC 660: This course provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.

This course is open to the general public-not limited to UMBC students. 

BTEC 656: Is a seminar-style course that is an in-depth exploration of prevailing methods and techniques used in biotechnology experimental design. The course focuses on the examination and critical evaluation of common practices used in setting up experimental protocols, and the types of statistical techniques used to draw inferences from experimental results. Literature research expands and deepens the student¿s understanding of key fields within the biotechnology area, and allows the student to gain more in-depth knowledge on subjects that are relevant to their careers. Oral presentations and written papers help to refine the students communications skills.

This course is open to the general public-not limited to UMBC students. 

BTEC 670: This course offers an overview of legal issues affecting biotechnology and other science-based industries and frames basic philosophical and ethical considerations regarding genetic data and manipulation. The course includes a discussion of intellectual property issues.

This course is open to the general public-not limited to UMBC students.

BTEC 685: In this course, students learn the fundamentals of managing projects in a systematic way. These fundamentals can be applied within any industry and work environment and will serve as the foundation for more specialized project management study. Principles and techniques are further reinforced through practical case studies and team projects in which students simulate project management processes and techniques.

This course is not limited to UMBC students and is open to the general public.

BTEC 664: In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.

This course is not limited to UMBC students and is open to the general public.