Biotechnology

http://www.miracosta.edu/BTEC

The expanding field of biotechnology devotes itself to improving human health through the research, development, testing, manufacturing, and marketing of products related to the biomedical and agricultural industries. The Biotechnology program provides both the theoretical background and practical experience necessary to gain employment in the biotechnology industry. Career paths include research, development, quality control and assurance, manufacturing, analytical testing, and lab technician work.

New Bachelor's Degree Program

The college is now offering a bachelor's degree in biomanufacturing. The program builds upon the associate degree program in biomanufacturing, allowing students who complete the associate degree or equivalent course work from other colleges to enter as juniors and earn a baccalaureate. Information about the program, including eligibility requirements, the application process, and upper-division tuition, is available under Bachelor's Degree.

Contact Information

Chair: Gail Baughman

Dean: Michael Fino

www.miracosta.edu/BTEC

Department: Biotechnology

Office: Building OC3600, 760.757.2121 x6874

Full-Time Faculty

Gail Baughman
Barbara Juncosa
Billyana Tsvetanova

Bachelor's Degree

Bachelor of Science Degree

Biomanufacturing

The biomanufacturing bachelor's degree program develops the skills, abilities, and knowledge for students to work in the unique environment of biological production, where the science thrives in partnership with quality and compliance. This degree program explicitly emphasizes the applied, quantitative analysis of biomanufacturing process design and performance.

The biomanufacturing bachelor's degree will prepare students for employment in technical or quality positions in the manufacturing sector of the biotechnology industry, which includes biotherapeutics, diagnostics, supplies and services, and industrial products.  

The biomanufacturing bachelor's degree program builds upon the college's associate degree program in biomanufacturing, allowing students who complete the associate degree or equivalent course work from other colleges to enter as juniors and earn a baccalaureate.

NOTE: All associate degree programs include the completion of a general education (GE) pattern of courses. Students earning the college' s associate degree in biomanufacturing must complete either the CSU-GE (Plan B) or the IGETC (Plan C) pattern to be eligible for admission to the bachelor's degree program.

Bachelor's Degree Requirements

The biomanufacturing bachelor's degree program requires the completion of 120 semester units that include the following:

  • 36-37 units of lower-division major course work

  • 37-41 units of lower-division general education course work (from Plans B or C)

  • 36 units of upper-division major course work

  • 9 units of upper-division general education course work

  • Transferable electives as necessary to complete 120 units.

Students are also required to complete a minimum of 12 units in residence at MiraCosta College and to achieve at least a 2.0 grade point average (GPA).

Eligibility Requirements for Admission

​​Qualified applicants will be selected for admission based on a comprehensive review process that gives additional weight to the following:

  • Completion of an associate degree in research and development, biomanufacturing, or equivalent.
  • Completion of additional 200-level BTEC courses.
  • Completion (or partial completion) of CSU-GE (Plan B) or IGETC (Plan C).
  • Relevant life experiences or special circumstances, such as disabilities, low family income, first generation college student, veteran status, and other criteria. For specifics on the comprehensive review process, see miracosta.edu/bachelors.

How to Apply

Students complete the standard online application to the college as well as the Application for the Bachelor of Science in Biomanufacturing, which is also available online.

Upper-Division Tuition

Upper-division course work costs $130 per unit, which is an additional $84 per unit currently charged for lower-division course work.

Program Student Learning Outcome Statements:

  • Students will be able to design and execute a project that identifies possible options of new biomanufacturing technologies that serve as process improvements, including technical and financial benefits, and write a report evaluating those options with a final recommendation.​
  • S​tudents will be able to perform an investigation that requires them to analyze an Out of Specification (OOS) occurrence during a production step in the manufacture of a biological substance, perform the analysis to justify the batch disposition, and incorporate this into a CAPA (Corrective Action Preventative Action) report.
Required courses: 
BTEC 300Supply Chain and Enterprise Resource Planning in Biomanufacturing3
BTEC 310Biomanufacturing Process Sciences5
BTEC 320Design of Experiments for Biomanufacturing4
BTEC 330Advanced Topics in Quality Assurance and Regulatory Affairs4
BTEC 340Six Sigma and Lean Manufacturing3
BTEC 360Design of Biomanufacturing Facilities, Critical Utilities, Processes, and Equipment3
BTEC 400Bioprocess Monitoring and Control4
BTEC 410Methods in Quality, Improvements, Investigations, and Audits4
BTEC 460Capstone Seminar in Biomanufacturing Technologies3
BTEC 470Capstone Seminar in Biomanufacturing Quality3
BIO 340Molecular Mechanisms of Disease3
BUS 302Leadership and Personal Development3
PHIL 302Bioethics3
Total Units45

Associate Degrees

Associate in Science Degree

Biomanufacturing

This program is designed to give students the theoretical background and practical experience necessary to work effectively in biomanufacturing at the entry level as well as to prepare them for advancement to the baccalaureate degree in biomanufacturing at MiraCosta College. Students may earn the associate degree by completing the certificate of achievement in biomanufacturing as well as a general education (GE) pattern of courses. To be eligible for admission to the bachelor's degree program, students must complete either the CSU-GE (Plan B) or the IGETC (Plan C) pattern. Students should meet with a MiraCosta counselor to develop a written educational plan for the specific degree they wish to earn.

Associate in Arts Degree

Research and Development

Students may earn the above-named associate degree by completing a certificate of achievement and the general education courses required for MiraCosta College's Associate in Arts degree (see Associate Degrees). Students should meet with a MiraCosta counselor to identify required courses and to develop a written educational plan for the specific degree or certificate they wish to earn.

Program Student Learning Outcome Statement:

  • Upon completion of the program, students will report that they were sufficiently developed to meet employer expectations for entry-level performance in a technical laboratory.

Certificates

Certificate of Achievement

Biomanufacturing

This program expands on the skills and theoretical foundation presented in the bioprocess technology certificate to further prepare entry-level technicians for employment in the regulated environment of biomanufacturing. Technicians in this field must learn and implement laboratory procedures and use specialized laboratory equipment in the production of a cell-based product. Competency in organizational, computational, and communication skills is required. This program is designed to give students the theoretical background and practical experience necessary to work effectively in biomanufacturing at the entry level as well as to prepare them for advancement to the baccalaureate degree in biomanufacturing at MiraCosta College. Graduates of this program can expect to be employed in various capacities, including quality control, quality assurance, production, applied research, process development, and analytical testing.

Program Student Learning Outcome Statement:

  • Upon completion of this program students will be able to successfully perform a technical laboratory task common to the biomanufacturing environment by employing the appropriate equipment and tools safely and effectively. 
Required courses: 
BIO 105Introductory Biology: Biotechnology in Society3-4
or BIO 110 Introductory Biology: Preparation for Pre-Health Professions (Lecture/Lab)
or BIO 111 Introductory Biology: Preparation for Pre-Health Professions (Lecture)
BIO 180Biostatistics4
or BTEC 180 Biostatistics
BTEC 110Basic Techniques in Biotechnology4
BTEC 120Business and Regulatory Practices in Biotechnology3
BTEC 210Data Analysis with Excel1
BTEC 211Technical Writing for Regulated Environments1
BTEC 221Bioprocessing: Cell Culture and Scale-up1.5
BTEC 222Bioprocessing: Large Scale Purification1.5
CHEM 108Preparatory Chemistry4
CHEM 110General Chemistry5
or CHEM 110H General Chemistry (Honors)
CHEM 111General Chemistry5
or CHEM 111H General Chemistry (Honors)
ENGL 100Composition and Reading4
Select three courses from the following:3
Advanced Cell Culture
Techniques in DNA Amplification
Techniques in Immunochemistry and ELISA
Internship Studies
Occupational Cooperative Work Experience
Total Units40-41

Certificate of Achievement

Bioprocess Technology

This certificate provides a foundation in, and practical application of, the technologies employed by biotechnology companies engaged in the production of cell-derived products from small to large scales. Through a combination of applied lecture and hands-on laboratory instruction, students acquire the confidence, competence, and compliance for technical work in a regulated environment. Bioprocess technologies encompass the operation of specialized equipment and instrumentation used to produce biopharmaceuticals or reagents utilized by biotechnology, pharmaceutical, and academic research labs. Students learn to grow a variety of cells, express a biomolecule of interest, and recover the desired biomolecule through a series of purification steps. They learn to follow good manufacturing practices by maintaining records in order to comply with quality system requirements and government regulations. This certificate is designed for bioprocess-technician skill development as well as professional development for those already employed in the industry.

Program Student Learning Outcome Statement:

  • Upon completion of the program, students will be able to successfully perform a technical laboratory task by employing the appropriate equipment and tools, safely and effectively.
Required courses: 
BTEC 110Basic Techniques in Biotechnology4
BTEC 120Business and Regulatory Practices in Biotechnology3
BTEC 211Technical Writing for Regulated Environments1
BTEC 221Bioprocessing: Cell Culture and Scale-up1.5
BTEC 222Bioprocessing: Large Scale Purification1.5
Select at least one course from the following:1
Data Analysis with Excel
Internship Studies
Occupational Cooperative Work Experience
Total Units12

Certificate of Achievement

Research and Development

The Research and Development certificate is designed to meet the increasing need for entry-level laboratory technicians, especially in the field of research and development. Technicians in this field must be proficient in the application of scientific methodology to solve problems. They must learn and implement laboratory procedures and use specialized laboratory equipment. Competency in organizational, computational and communication skills is required. This three-semester program is designed to give students the theoretical background and practical experience necessary to be an effective laboratory technician as well as to prepare them for upper division course work in the biosciences. Graduates of this biotechnology program can expect to be employed in various capacities, including quality control, quality assurance, production, applied research, product development, analytical testing, and academic (basic) research.

Program Student Learning Outcome Statement:

  • Upon completion of the program, students will report that they were sufficiently developed to meet employer expectations for entry-level performance in a technical laboratory.
Required courses: 
BIO 105Introductory Biology: Biotechnology in Society3-4
or BIO 110 Introductory Biology: Preparation for Pre-Health Professions (Lecture/Lab)
or BIO 111 Introductory Biology: Preparation for Pre-Health Professions (Lecture)
BTEC 110Basic Techniques in Biotechnology4
BTEC 120Business and Regulatory Practices in Biotechnology3
BTEC/BIO 180Biostatistics4
CHEM 108Preparatory Chemistry4
CHEM 110General Chemistry5
or CHEM 110H General Chemistry (Honors)
CHEM 111General Chemistry5
or CHEM 111H General Chemistry (Honors)
CSIT 110Computer Applications1-3
or CSIT 115 Intermediate Computer Applications
or CSIT 128 Microsoft Excel for Business
or BTEC 210 Data Analysis with Excel
ENGL 100Composition and Reading4
MATH 64Intermediate Algebra4
Select at least 4 electives from below:4-5
Advanced Cell Culture
Techniques in DNA Amplification
Recombinant DNA
Principles of Separation and HPLC
Techniques in Immunochemistry and ELISA
Technical Writing for Regulated Environments
Bioprocessing: Cell Culture and Scale-up
Bioprocessing: Large Scale Purification
Internship Studies
Occupational Cooperative Work Experience
Total Units41-45

Certificate of Proficiency

Laboratory Skills

This certificate is designed to meet the increasing need for trained and competent associates in laboratory environments. The required courses provide students with fundamental laboratory skills to start or enhance a career in the biosciences. Students completing this certificate can expect employment utilizing their technical skills in the performance of tests and routine tasks inherent to a wide range of laboratory environments. This certificate is intended for the development of general laboratory skills as well as professional growth for those already employed in the industry.

Program Student Learning Outcome Statement:

  • Upon completion of the program, students will be able to successfully perform a technical laboratory task by employing the appropriate equipment and tools, safely and effectively.​
Required courses: 
BTEC 110Basic Techniques in Biotechnology4
BTEC 120Business and Regulatory Practices in Biotechnology3
Select at least four courses from the following:4-5
Advanced Cell Culture
Techniques in DNA Amplification
Recombinant DNA
Principles of Separation and HPLC
Techniques in Immunochemistry and ELISA
Data Analysis with Excel
Technical Writing for Regulated Environments
Bioprocessing: Cell Culture and Scale-up
Bioprocessing: Large Scale Purification
Internship Studies
Occupational Cooperative Work Experience
Total Units11-12

How to Read Course Descriptions

For more detailed information about a course, such as its content, objectives, and fulfillment of a degree, certificate, or general education requirement, please see the official course outline of record, available at http://www.miracosta.edu/governance/coursesandprograms/courseoutlines.html.

Courses

BTEC 110: Basic Techniques in Biotechnology

Units: 4
Prerequisites: CHEM 108.
Advisory: ACE 150, ENGL 50, ESL 150, or eligibility determined by the English placement process; and BIO 105, BIO 110, or BIO 111.
Acceptable for Credit: CSU
Lecture 2 hours, laboratory 6 hours. (0430.00)
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)

BTEC 120: Business and Regulatory Practices in Biotechnology

Units: 3
Prerequisites: None
Acceptable for Credit: CSU
Lecture 3 hours. (0430.00)
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: MATH 64, MATH 95, or eligibility determined by the math placement process.
Advisory: BIO 110 or BIO 111.
Enrollment Limitation: Not open to students with prior credit in BIO 180, BUS 204, PSYC 104, PSYC 104H, SOC 104, or SOC 104H.
Acceptable for Credit: CSU, UC
Lecture 3 hours, laboratory 3 hours. (0430.00)
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/BTEC 180, BUS 204, MATH 103, PSYC 104/SOC 104, or PSYC 104H/SOC 104H.

BTEC 201: Advanced Cell Culture

Units: 1
Prerequisites: None
Advisory: BTEC 110.
Acceptable for Credit: CSU
Lecture 0.50 hour, laboratory 1.50 hours. (0430.00)
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: None
Advisory: BTEC 110.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour. (0430.00)
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 set up, performance, and evaluation of the outcome of the technique. The course assumes some prior knowledge of solution preparation and gel electrophoresis.

BTEC 204: Recombinant DNA

Units: 1
Prerequisites: None
Advisory: BTEC 110.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour. (0430.00)
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: None
Advisory: BTEC 110.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour. (0430.00)
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: None
Advisory: BTEC 110.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour. (0430.00)
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 100.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 0.75 hour. (0430.00)
Course Typically Offered: Fall, Spring

This course teaches 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, ENGL 50, ESL 150, or eligibility determined by the English placement process.
Acceptable for Credit: CSU
Lecture 1 hour. (0430.00)
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: None
Advisory: BTEC 110 and BTEC 120.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 2.25 hours. (0430.00)
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: None
Advisory: BTEC 110 and BTEC 120.
Acceptable for Credit: CSU
Lecture 0.75 hour, laboratory 2.25 hours. (0430.00)
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 292: Internship Studies

Units: 0.5-3
Prerequisites: None
Corequisite: 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: 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 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.

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. (0430.00)
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 Cooperative Work Experience

Units: 1-6
Prerequisites: None
Corequisite: 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: CSU
Course 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.

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. (0430.00)
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.

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. (0430.00)
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.

BTEC 320: Design of Experiments for Biomanufacturing

Units: 4
Prerequisites: BTEC 110, and BTEC 180 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. (0430.00)
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.

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. (0430.00)
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.

BTEC 340: Six Sigma and Lean Manufacturing

Units: 3
Prerequisites: BTEC 120, and BTEC 180 or BIO 180.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours. (0430.00)
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 administered by the American Society for Quality for qualification with a white 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: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 3 hours. (0430.00)
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. (0430.00)
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. (0430.00)
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.

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. (0430.00)
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.

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. (0430.00)
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.