BTEC 107: Exploring Biotechnology: Emerging Trends, Careers, and the Local Industry

Units: 3
Prerequisites: None
Acceptable for Credit: CSU
Lecture 3 hours.
Course Typically Offered: Fall, Spring

This course introduces students to the emerging role of biotechnology in modern society. It examines the origins and impact of the biotechnology industry from physiological and socio-cultural aspects, including how biotechnology advances have transformed individual lives and communities. Topics include new technologies in development and the role of biotechnology in addressing societal challenges, such as the COVID-19 pandemic and climate change. Students are oriented to biotechnology careers, employment trends, and the required high-tech, high-touch workforce skills necessary for success in a globally and locally robust professional environment.

BTEC 108: Biomanufacturing: From Gene to Product

Units: 3
Prerequisites: None
Advisory: ENGL 100 or ENGL 100H.
Enrollment Limitation: Not open to students with prior credit in BTEC 108H.
Acceptable for Credit: CSU, UC
Lecture 2 hours, laboratory 3 hours.
Course Typically Offered: Fall, Spring

This course serves as an introduction to the interdisciplinary field of biomanufacturing with content appropriate for a wide range of students, including non-science majors. Topics include a general examination of biological and chemical principles as they relate to the development, production, recovery, and analysis of products made by living organisms. Lecture content emphasizes the use of living systems to produce therapeutics, foods, cosmetics, and fuels. The course addresses how biomanufacturing may impact current societal challenges with a discussion of the scientific, business, and legal/ethical issues. UC CREDIT LIMITATION: Credit for BTEC 108 or BTEC 108H.

BTEC 108H: Biomanufacturing: From Gene to Product (Honors)

Units: 3
Prerequisites: None
Advisory: ENGL 100 or ENGL 100H.
Enrollment Limitation: Not open to students with prior credit in BTEC 108.
Acceptable for Credit: CSU, UC
Lecture 2 hours, laboratory 3 hours.
Course Typically Offered: Fall, Spring

This course serves as an introduction to the interdisciplinary field of biomanufacturing with content appropriate for a wide range of students, including non-science majors. Topics include a general examination of biological and chemical principles as they relate to the development, production, recovery, and analysis of products made by living organisms. Lecture content emphasizes the use of living systems to produce therapeutics, foods, cosmetics, and fuels. The course addresses how biomanufacturing may impact current societal challenges with a discussion of the scientific, business, and legal/ethical issues. This honors course offers students the opportunity to complete, document, and discuss independent scientific research. UC CREDIT LIMITATION: Credit for BTEC 108 or BTEC 108H.

BTEC 110: Basic Techniques in Biotechnology

Units: 5
Prerequisites: BIO 105, BIO 204, BIO 204H, BTEC 108, or BTEC 108H.
Enrollment Limitation: Concurrent enrollment in BIO 105, BIO 204, BIO 204H, BTEC 108, or BTEC 108H if prerequisite not met and not open to students with prior credit in BTEC 110H.
Acceptable for Credit: CSU, UC
Lecture 3 hours, laboratory 6 hours.
Course Typically Offered: Fall, Spring

This course focuses on the basic laboratory skills needed for employment in the biotechnology/biomanufacturing industry. Students learn laboratory safety and documentation while acquiring skills in the maintenance and calibration of basic lab equipment, calculation and preparation of lab solutions and media, and routine handling of cell cultures. Students also develop fundamental skills in spectroscopy, centrifugation, performance of assays, gel electrophoresis, and the purification and handling of biological molecules, such as proteins. UC CREDIT LIMITATION: Credit for BTEC 110 or BTEC 110H. (Materials Fee: $30.00)

BTEC 110H: Basic Techniques in Biotechnology (Honors)

Units: 5
Prerequisites: BIO 105, BIO 204, BIO 204H, BTEC 108, or BTEC 108H.
Enrollment Limitation: Concurrent enrollment in BIO 105, BIO 204, BIO 204H, BTEC 108, or BTEC 108H if prerequisite not met and not open to students with prior credit in BTEC 110.
Acceptable for Credit: CSU, UC
Lecture 3 hours, laboratory 6 hours.
Course Typically Offered: Fall, Spring

This course focuses on the basic laboratory skills needed for employment in the biotechnology/biomanufacturing industry. Students learn laboratory safety and documentation while acquiring skills in the maintenance and calibration of basic lab equipment, calculation and preparation of lab solutions and media, and routine handling of cell cultures. Students also develop fundamental skills in spectroscopy, centrifugation, performance of assays, gel electrophoresis, and the purification and handling of biological molecules, such as proteins. This honors course offers students the opportunity to complete, document, and discuss independent scientific research. UC CREDIT LIMITATION: Credit for BTEC 110 or BTEC 110H. (Materials Fee: $30.00)

BTEC 120: Business and Regulatory Practices in Biotechnology

Units: 3
Prerequisites: None
Acceptable for Credit: CSU
Lecture 3 hours.
Course Typically Offered: Fall, Spring

This course examines basic business principles and practices utilized in the discovery, development, and production phases of new product development. It explores the role of governmental oversight and regulation in assuring the safety, efficacy, and quality of a biotechnology product.

BTEC 180: Biostatistics

Units: 4
Prerequisites: Prealgebra or eligibility determined by the math placement process.
Advisory: BIO 110,BIO 111, BIO 105, BIO 202, BIO 204, BIO 204H, BTEC 108, or BTEC 108H.
Enrollment Limitation: Not open to students with prior credit in BTEC 180H.
Acceptable for Credit: CSU, UC
Lecture 3 hours, laboratory 3 hours.
Course Typically Offered: Fall, Spring

This introductory statistics course covers the principles and practice of statistical design and analysis for scientific experimentation. Topics include hypothesis formation, experimental design and execution, data analysis, and communication with application to scientific fields, such as the biological and health sciences. The course includes laboratory application with extensive use of computer software for statistical analysis and simulation. UC CREDIT LIMITATION: Credit for BTEC 180/BTEC 180H, BUS 204/BUS 204H, MATH 103/MATH 103S, PSYC 104/PSYC 104H, or SOC 125. Some CSU campuses may also impose this credit limitation.

BTEC 180H: Biostatistics (Honors)

Units: 4
Prerequisites: Prealgebra or eligibility determined by the math placement process.
Advisory: BTEC 108 or or BTEC 108H or BIO 105 or BIO 110 or BIO 111 or BIO 202 or BIO 204 BIO 204H
Enrollment Limitation: Not open to students with prior credit in BTEC 180.
Acceptable for Credit: CSU, UC
Lecture 3 hours, laboratory 3 hours.
Course Typically Offered: Fall, Spring

This introductory statistics course covers the principles and practice of statistical design and analysis for scientific experimentation. As an honors course, it offers students in-depth coverage of course topics and the opportunity to analyze data for an independent project. Topics include hypothesis formation, experimental design and execution, data analysis, and communication with application to scientific fields, such as the biological and health sciences. The course includes laboratory application with extensive use of computer software for statistical analysis and simulation. UC CREDIT LIMITATION: Credit for BTEC 180/BTEC 180H, BUS 204/BUS 204H, MATH 103/MATH 103S, PSYC 104/PSYC 104H, or SOC 125. Some CSU campuses may also impose this credit limitation.

BTEC 201: Advanced Cell Culture

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU, UC
Lecture 0.50 hour, laboratory 1.50 hours.
Course Typically Offered: Spring

This advanced course teaches skills in the proper handling of cells from higher organisms, such as plants, mammals, and insects, that are routinely maintained in culture in the biotechnology laboratory. Instruction focuses on growth and manipulation techniques and long-term maintenance of various laboratory cell cultures that may include anchorage-dependent and suspension cell lines as well as stem cell cultures.

BTEC 203: Techniques in DNA Amplification

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall or Spring every 3rd sem

This advanced course provides skills in the performance of the polymerase chain reaction (PCR), a technique commonly used to amplify DNA in forensics and the biotechnology laboratory. Instruction focuses on understanding the process; potential applications of DNA amplification; and the skills related to the setup, performance, and evaluation of the technique's outcome. The course assumes some prior knowledge of solution preparation and gel electrophoresis.

BTEC 204: Recombinant DNA

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall or Spring every 3rd sem

This advanced course provides skills in recombinant DNA technology used to analyze and manipulate DNA in the biotechnology laboratory. Students learn about the process of cloning and analyzing DNA and acquire the skills necessary to cut, piece together, and introduce new DNA molecules into prepared host bacterial cells.

BTEC 206: Principles of Separation and HPLC

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall or Spring every 3rd sem

This advanced course provides skills in the separation of biomolecules from complex mixtures using high performance liquid chromatography (HPLC). Instruction focuses on understanding the principles of separation, acquiring skills in the separation of various biomolecules, and analyzing the outcome for the purpose of determining system performance and biomolecular purification. The course assumes some prior knowledge of solution preparation, assays, and spectroscopy.

BTEC 207: Techniques in Immunochemistry and ELISA

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall or Spring every 3rd sem

This advanced course provides skills in the use of antibody reagents as a tool in the biotechnology laboratory. It focuses on the nature and specificity of antibody reagents for the identification and quantification of biological molecules. Students learn how to set up, perform, and analyze techniques utilizing antibodies, such as Westerns and ELISAs.

BTEC 210: Data Analysis with Excel

Units: 1
Prerequisites: None
Advisory: CSIT 101
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall, Spring

This course teaches students how modern spreadsheet programs can be used to collect and organize data for subsequent tabulation, summarization, and graphical display. It utilizes various forms of scientific data to teach the techniques and skill that facilitate the capture, analysis, and management of data. Topics include importing and organizing data, filtering and sorting, graphing, and statistical analysis functions.

BTEC 211: Technical Writing for Regulated Environments

Units: 1
Prerequisites: None
Advisory: ACE 150, BTEC 110, ESL 150, or eligibility determined by the English placement process and BTEC 110H.
Acceptable for Credit: CSU
Lecture 1 hour.
Course Typically Offered: Fall, Spring

This course provides the requisite tools to understand why technical writing exists and how that writing works in conjunction with the many types of documents found in regulated environments. It also develops the techniques needed to deliver clear and complete passages with precise language. Students apply best practices for technical writing to a variety of documents, including reports, standard operating procedures (SOP), and investigations.

BTEC 221: Bioprocessing: Cell Culture and Scale-up

Units: 1.5
Prerequisites: BTEC 110 or BTEC 110H.
Advisory: BTEC 120
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 2.25 hours.
Course Typically Offered: Fall, Spring

This laboratory course develops the skills and knowledge related to the culture of cells in increasingly larger scales for the production of biological molecules. Students grow and monitor a variety of cells (bacterial, yeast, and/or mammalian) on a laboratory scale that emulates the large-scale production used in industry. They become familiar with the cleaning, sterilization, aseptic inoculation, operation, and monitoring of fermenters and bioreactors. The course emphasizes the use of current Good Manufacturing Practices (cGMPs) and process control strategies, and students gain experience following Standard Operating Procedures (SOPs).

BTEC 222: Bioprocessing: Large Scale Purification

Units: 1.5
Prerequisites: BTEC 110 or BTEC 110H.
Advisory: BTEC 120
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 2.25 hours.
Course Typically Offered: Fall, Spring

This laboratory course develops the skills and knowledge related to purification of biological molecules produced on a large scale. Students utilize the most common types of separation equipment, including tangential flow filtration, centrifugation, and column chromatography. They become familiar with the cleaning, sanitization, calibration, operation, and monitoring of large-scale purification equipment. The course emphasizes the use of current Good Manufacturing Practices (cGMPs) and process control strategies, and students gain experience following Standard Operating Procedures (SOPs).

BTEC 231: Gene Editing Techniques: CRISPR-Cas9

Units: 1
Prerequisites: BTEC 110 or BTEC 110H.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour.
Course Typically Offered: Fall or Spring

This advanced course provides skills in the performance of the revolutionary genome editing technique CRISPR-Cas9. Instruction focuses on a deep understanding of this powerful and popular gene-editing technique to better appreciate the promise, risks, and ethics behind its many applications. Laboratory activities develop skills related to the setup, performance, and evaluation of the technique's outcome. The course assumes some prior knowledge of solution preparation and aseptic streak-plating of bacterial cultures.

BTEC 292: Internship Studies

Units: 0.5-14
Prerequisites: None
Corequisite: Complete 54 hours of work per unit, paid or unpaid.
Enrollment Limitation: Instructor, dept chair, and Career Center approval. Fourteen unit maximum in any combination of work experience education and/or internship studies per semester.
Acceptable for Credit: CSU
Course Typically Offered: To be arranged

This course provides students the opportunity to apply the theories and techniques of their discipline in an internship position in a professional setting under the instruction of a faculty-mentor and site supervisor. It introduces students to aspects of the roles and responsibilities of professionals employed in the field of study. Topics include goal-setting, employability skills development, and examination of the world of work as it relates to the student's career plans. Students must develop new learning objectives and/or work/intern at a new site upon each enrollment.

BTEC 296: Topics in Biotechnology

Units: 1-4
Prerequisites: None
Acceptable for Credit: CSU
Lecture 1 hour.
Lecture 2 hours.
Lecture 3 hours.
Lecture 4 hours.
Course Typically Offered: To be arranged

This course gives students an opportunity to study topics in Biotechnology that are not included in regular course offerings. Each Topics course is announced, described, and given its own title and 296 number designation in the class schedule.

BTEC 299: Occupational Work Experience Education

Units: 0.5-14
Prerequisites: None
Corequisite: Complete 54 hours of work per unit, paid or unpaid.
Enrollment Limitation: Career Center approval. Fourteen unit maximum in any combination of work experience education and/or internship studies per semester.
Acceptable for Credit: CSU
Course Typically Offered: Fall, Spring, and Summer

This course is intended for students who are employed in a job directly related to their major or career area of interest. It allows such students the opportunity to apply the theories and skills of their discipline to their position and to undertake new responsibilities and learn new skills at work. Topics include goal-setting, employability skills development, and examination of the world of work as it relates to the student's career plans. Students must develop new learning objectives and/or work/intern at a new site upon each enrollment.

BTEC 300: Supply Chain and Enterprise Resource Planning in Biomanufacturing

Units: 3
Prerequisites: BTEC 120.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours.
Course Typically Offered: Fall

Students gain knowledge of how companies manage the complete flow of materials in a supply chain from suppliers to customers. This course covers the design, planning, execution, monitoring, and control of raw materials, personnel resources, inventory management, and distribution. At the end students will have the knowledge required to take the CPIM (Certified in Production and Inventory Management) certification test administered by APICS (the American Production and Inventory Control Society). This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 310: Biomanufacturing Process Sciences

Units: 5
Prerequisites: BTEC 221 and BTEC 222.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours, laboratory 6 hours.
Course Typically Offered: Spring

This lecture/laboratory course examines the biological, physical, and chemical scientific principles that support the design, development, and optimization of key parameters in a biomanufacturing process. Process sciences covers the essential theories that underpin the biomanufacturing operations from product formation through product purification and how those operations scale up and scale down. The topics include fermenter and bioreactor design and the design of downstream processes that maximize the yield, safety, and efficacy of a protein pharmaceutical. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 320: Design of Experiments for Biomanufacturing

Units: 4
Prerequisites: BTEC 110 or BTEC 110H and BTEC 180 or BTEC 180H.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours, laboratory 3 hours.
Course Typically Offered: Fall

This course teaches formalized design of experiments (DOE), a system that optimizes a process through the methodical varying of key parameters and a formalized approach to analyzing, interpreting, and applying the results. DOE is designed to make any process more robust and minimize variability from external sources. The course builds upon the statistical concepts required for DOE, including hypothesis testing, confidence intervals, statistical models, and analysis of variance (ANOVA). The DOE approach systematically varies the parameters of a biomanufacturing process to improve its operation. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 330: Advanced Topics in Quality Assurance and Regulatory Affairs

Units: 4
Prerequisites: BTEC 120.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 4 hours.
Course Typically Offered: Spring

This course builds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of the International Council for Harmonisation Q8 through Q11. The course pays special attention to the topics of quality risk management, qualification, and validation. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 340: Six Sigma and Lean Manufacturing

Units: 3
Prerequisites: BTEC 120 and BTEC 180 or BTEC 180H.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours.
Course Typically Offered: Spring

This course covers the Six Sigma approach to the maintenance and improvement of biomanufacturing processes. It incorporates the DMAIC phases: define, measure, analyze, improve, and control. The course covers the use and implementation of lean manufacturing tools that biomanufacturing companies use to reduce waste. At the end of the course, students will be prepared to take the certification test for qualification with a yellow belt in Six Sigma. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 360: Design of Biomanufacturing Facilities, Critical Utilities, Processes, and Equipment

Units: 3
Prerequisites: BTEC 120, BTEC 221, and BTEC 222.
Enrollment Limitation: Concurrent enrollment in BTEC 221 and BTEC 222 if prerequisites not met.
Lecture 3 hours.
Course Typically Offered: Fall

Students evaluate how the design of a biomanufacturing facility maintains appropriate levels of cleanliness and sterility and promotes the production of safe and effective products. Students analyze the design of the processes, equipment, and instrumentation used in biological production to generate critical utilities, aseptic systems, environmental control and monitoring, upstream production, and downstream (recovery and purification) production within a regulated environment. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 400: Bioprocess Monitoring and Control

Units: 4
Prerequisites: BTEC 310.
Enrollment Limitation: Open only to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours, laboratory 3 hours.
Course Typically Offered: Fall

This course covers the measurement, monitoring, modeling, and control of biomanufacturing processes and the statistical methodology used for measuring, analyzing, and controlling quality during the manufacturing process, including control charts and the analysis of process capabilities. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 410: Methods in Quality, Improvements, Investigations, and Audits

Units: 4
Prerequisites: BTEC 330 and BTEC 340.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 4 hours.
Course Typically Offered: Fall

This course examines investigational methods used by quality assurance departments to analyze process deviations and make decisions about severity of deviation. Students learn to write industry-standard corrective and preventive action (CAPA) reports to conclude what corrective and preventive actions result from the investigation. The course also covers how a company would perform an audit in anticipation of an inspection by the Food and Drug Administration or for the supplier of a key raw material. Course content is aligned with the American Society for Quality's Body of Knowledge for a Certified Quality Technician examination. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 460: Capstone Seminar in Biomanufacturing Technologies

Units: 3
Prerequisites: BTEC 310.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours.
Course Typically Offered: Spring

This course examines the breadth of products that are produced through biological processes. The course will focus on the advances and emerging technologies in biological production and purification operations. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC 470: Capstone Seminar in Biomanufacturing Quality

Units: 3
Prerequisites: BTEC 330.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours.
Course Typically Offered: Spring

This course examines the process by which the quality systems of biomanufacturing evolve by examining a selected current trend in the laws and regulations governing biopharmaceutical manufacturing. Students evaluate the effectiveness of the laws and regulations governing biopharmaceutical manufacturing. This course serves as a capstone experience for students in biomanufacturing quality. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.