StemCell Therapy

BTEC110: Basic Techniques in Biotechnology

Units: 4Prerequisites: BIO105 and CHEM140 or one year of high school chemistry (within 4 years), or qualification through a chemistry placement exam.Advisory: ACE150, ENGL50, ESL150, or eligibility determined by the English placement process.Acceptable for Credit: CSULecture 2 hours, laboratory 6 hours. Course Typically Offered: Fall, Spring

This course focuses on the basic laboratory skills needed for employment in the bioscience/biotechnology 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 both bacterial and mammalian cell cultures (tissue culture). Students also develop fundamental skills in spectroscopy, centrifugation, performance of assays, gel electrophoresis, and the purification and handling of biological molecules, such as proteins and DNA. (Materials Fee: $30.00)

BTEC120: Business and Regulatory Practices in Biotechnology

Units: 3Prerequisites: NoneAcceptable for Credit: CSULecture 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.

BTEC180: Biostatistics

Units: 4Prerequisites: MATH64, MATH102, or eligibility determined by the math placement process.Advisory: BIO105, BIO110, BIO111, BIO202, or BIO204.Enrollment Limitation: Not open to students with prior credit in BIO 180, BUS204, PSYC104, PSYC104H, SOC104, or SOC104H.Acceptable for Credit: CSU, UCLecture 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 BIO 180/BTEC180, BUS204, MATH103, PSYC104/SOC104, or PSYC104H/SOC104H.

BTEC201: Advanced Cell Culture

Units: 1Prerequisites: BTEC110.Acceptable for Credit: CSULecture 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.

BTEC203: Techniques in DNA Amplification

Units: 1Prerequisites: BTEC110.Acceptable for Credit: CSULecture 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.

BTEC204: Recombinant DNA

Units: 1Prerequisites: BTEC110.Acceptable for Credit: CSULecture 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.

BTEC206: Principles of Separation and HPLC

Units: 1Prerequisites: BTEC110.Acceptable for Credit: CSULecture 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.

BTEC207: Techniques in Immunochemistry and ELISA

Units: 1Prerequisites: BTEC110.Acceptable for Credit: CSULecture 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.

BTEC210: Data Analysis with Excel

Units: 1Prerequisites: NoneAdvisory: CSIT101.Acceptable for Credit: CSULecture 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.

BTEC211: Technical Writing for Regulated Environments

Units: 1Prerequisites: NoneAdvisory: BTEC110 and ACE150, ENGL50, ESL150, or eligibility determined by the English placement process.Acceptable for Credit: CSULecture 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.

BTEC221: Bioprocessing: Cell Culture and Scale-up

Units: 1.5Prerequisites: BTEC110.Advisory: BTEC120.Acceptable for Credit: CSULecture 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).

BTEC222: Bioprocessing: Large Scale Purification

Units: 1.5Prerequisites: BTEC110.Advisory: BTEC120.Acceptable for Credit: CSULecture 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).

BTEC292: Internship Studies

Units: 0.5-3Prerequisites: NoneCorequisite: Complete 75 hrs paid or 60 hrs non-paid work per unit.Enrollment Limitation: Instructor, dept chair, and Career Center approval. May not enroll in any combination of cooperative work experience and/or internship studies concurrently.Acceptable for Credit: CSUCourse 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 intern at a new site upon each repetition. Students may not earn more than 16 units in any combination of cooperative work experience (general or occupational) and/or internship studies during community college attendance.

BTEC296: Topics in Biotechnology

Units: 1-4Prerequisites: NoneAcceptable for Credit: CSULecture 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.

BTEC299: Occupational Cooperative Work Experience

Units: 1-6Prerequisites: NoneCorequisite: Complete 75 hrs paid or 60 hrs non-paid work per unit.Enrollment Limitation: Career Center approval. May not enroll in any combination of cooperative work experience and/or internship studies concurrently.Acceptable for Credit: CSUCourse Typically Offered: To be arranged

Cooperative Work Experience is intended for students who are employed in a job directly related to their major. 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 may not earn more than 16 units in any combination of cooperative work experience (general or occupational) and/or internship studies during community college attendance.

BTEC300: Supply Chain and Enterprise Resource Planning in Biomanufacturing

Units: 3Prerequisites: BTEC120.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

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.

BTEC310: Biomanufacturing Process Sciences

Units: 5Prerequisites: BTEC221 and BTEC222.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: Fall

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.

BTEC320: Design of Experiments for Biomanufacturing

Units: 4Prerequisites: BTEC110, and BTEC180 or BIO 180.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: Spring

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.

BTEC330: Advanced Topics in Quality Assurance and Regulatory Affairs

Units: 4Prerequisites: BTEC120.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 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.

BTEC340: Six Sigma and Lean Manufacturing

Units: 3Prerequisites: BTEC120 and BTEC180.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. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.

BTEC360: Design of Biomanufacturing Facilities, Critical Utilities, Processes, and Equipment

Units: 3Prerequisites: BTEC120, BTEC221, and BTEC222.Enrollment Limitation: Concurrent Enrollment in BTEC221 and BTEC222 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.

BTEC400: Bioprocess Monitoring and Control

Units: 4Prerequisites: BTEC310.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.

BTEC410: Methods in Quality, Improvements, Investigations, and Audits

Units: 4Prerequisites: BTEC330 and BTEC340.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 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.

BTEC460: Capstone Seminar in Biomanufacturing Technologies

Units: 3Prerequisites: BTEC310.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

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.

BTEC470: Capstone Seminar in Biomanufacturing Quality

Units: 3Prerequisites: BTEC330.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.

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Biotechnology < MiraCosta College

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