Transfers ToNot transferableDescriptionProgram. This course focuses on science and mathematics topics that are critical to success for students entering an RN program. It provides a clinically pertinent review of select anatomy, physiology, nutrition, and microbiology topics for students entering nursing school. It is especially designed for students that have had an extended time period between finishing their pre-nursing requirements and entering nursing school. This course is taught by a panel of experts in the field. Case studies are extensively used in order to contextualize the material. This is a Pass/No Pass only course. Biotechnology Department DEGREES: Biomanufacturing (BS) Industrial Biotechnology (AS) CERTIFICATES OF ACHIEVEMENT Industrial Biotechnology Biotechnology Laboratory Assistant Stem Cells and Cell-Based Technologies COURSES: BIOT (Biotechnology) COLLEGE ARE YOU THE KIND OF PERSON WHO... � ...desires to observe, learn, analyze, evaluate, or solve problems? � ...enjoys to question and explore physical or biological happenings? � ...likes to work hands-on with objects, machines, tools, plants, or animals? � ...is interested in math and/or thinking analytically to solve complex problems? ARE YOU THE KIND OF PERSON WHO... � ...desires to work hands-on with objects, machines, tools, plants, or animals? � ...enjoys work and play outside, insluding use your physical or athletic abilities? � ...likes to follow directions to organize, plan and complete a project or task? � ...is interested in attaining employment as soon as possible? CONTACT INFORMATION: School of Mathematics and Sciences Building: 2700 Room 2719B Phone Number: (707) 864-7110 Fax Number: (707) 646-2054 Dean: Joseph Ryan GPS provides possible course pathways to reach the destination of program completion Biotechnology Biomanufacturing Bachelor of Science (Baccalaureate) Solano Community College is one of fifteen community colleges in the state of California to offer a pilot four year, or baccalaureate, degree. Solano Community College's degree is a Bachelor of Science in Biomanufacturing. In biomanufacturing scientists develop techniques to grow genetically engineered cells (bacterial, yeast, or animal cells) in large tanks called bioreactors and develop methods to purify the protein that the cells produce. Then technicians use analytical techniques to prove the purity of the isolated protein. In the future Biomanufacturing will be expanded to include the industrial production of biofuels, biomaterials, stem cells, and other products currently manufactured using chemical rather than biological techniques. Program Description The Biomanufacturing program builds upon the Associate in Science in Industrial Biotechnology. In the baccalaureate program students gain knowledge in biology, chemistry, engineering, statistics, quality, regulatory affairs, and business. Students use biomanufacturing laboratory facilities to gain process development skills. Many of the courses have been designed with curriculum that aligns with the requirements of certifications from professional organizations. The Bachelor of Science is awarded upon successful completion of a total of 120 units that include 60 lower-division units and ten upper-division major courses, three upper division general education courses, and electives. All courses in the major must be completed with a minimum grade of C. Program Outcomes Technology: 1. Identify and critically analyze two viable options for a biomanufacturing process. The critical analysis will include the technical, financial, and environmental impact of the two options as well as the identification of the benefits and disadvantages of each. 2. Produce a professional report and presentation representing their opinion regarding the advantages of selecting a specific biomanufacturing process. Quality: 3. Demonstrate the skills needed to conduct an investigation and analysis of an Out of Specification deviation that occurred during a production step in the manufacturing of a pharmaceutical protein. The student will be able to determine the impact of the OOS deviation on the batch of protein. 4. Produce a written Corrective Action Preventative Action report in a format standard to the industry. The report will include evidence to justify their conclusions and action plan. 5. Demonstrate the ability to apply Quality by Design (QbD) principles (understanding of the product, the process, and the process control) as adopted by the U.S. Food and Drug Administration (FDA) to design a robust, stable, and controlled manufacturing process for a protein pharmaceutical that can be carried out under current Good Manufacturing Practices (cGMPs). This includes the ability to predetermine values and potential ranges of the critical quality attributes (CQAs) of the product and the critical material attributes (CMAs) of the materials. Students will also be able to determine which parameters would benefit from a Design of Experiments (DoE) approach for their optimization, and construct a strategy for experimental planning and data analysis. 6. Use a quality risk assessment approach to perform a criticality assessment to determine the Critical Process Parameters (CPPs) that would need to be monitored and controlled. Biotechnology REQUIRED COURSES First Semester...........................................................Units BIOT 401 Biomanufacturing Process Sciences................. 5 BIOT 407 Advanced Topics in Quality Assurance and . .. Regulatory Affairs. ....................................................... 4 ENGL 400 Advanced Technical Writing: Writing in the Scientific Professions.................................................. 3 Second Semester......................................................Units BIOT 402 Design of Experiments for Biomanufacturing....................................................... 4 BIOT 403 Design of Biomanufacturing Facilities, Critical .. Utilities, Processes, and Equipment............................ 4 BIOT 404 Bioprocess Monitoring and Control................. 5 Third Semester..........................................................Units BIOT 405 Emerging Biomanufacturing Technologies....... 3 BIOT 406 Supply Chain and Enterprise Resource Planning...................................................................... 3 BIOT 408 Six Sigma and Lean Manufacturing.................. 4 PHIL 400 Bioethics........................................................... 3 Fourth Semester.......................................................Units BIOT 409 Methods in Quality Improvements, Investigations and Audits............................................ 4 BIOT 410 Emerging Trends in Biomanufacturing Quality........................................................................ 3 BUS 400 Project Management....................................... 3 Total Units.........................................................48 Units Program Requirements and Courses The program has been designed to follow a cohort model: all students take all of the courses in order. Biomanufacturing Program Eligibility Requirements The Biomanufacturing Bachelor of Science program admits students once per year in the fall. Eligibility requirements, application process, and related information is available online at http://www.solano.edu/biomanufacturing. All of the following requirements must be met in order to apply to the Biomanufacturing program. For any questions about these items, meet with an Academic Counselor. For counseling information, please visit http://www.solano.edu/counseling/. 1. Overall cumulative grade point average (GPA) of 2.5 for ALL college coursework. 2. Completion of, or current Spring semester enrollment in Biomanufacturing Program Courses must be completed with a minimum grade of C and with a combined GPA of 2.5 BIO 002 Cell and Molecular BIology........................... 5 BIOT 001 Principles of Biotechnology......................... 3 BIOT 052 Business, Regulatory, and Quality Practices in Biotechnology..................................... 3 BIOT 062 Cell Culture and Protein Recovery.............. 4 BIOT 063 Biotechnology Intrumentation: Quality Control & Genetic Engineering.................. 4 CHEM 001 General Chemistry I.................................. 5 STAT C1000 Introduction to Statistics......................... 4 3. Completion of lower division Cal-GETC or CSU General Education Breadth. 4. Applicants who have attended college outside the United States must have transcripts evaluated by a National Association of Credential Evaluation Services (NACES) approved independent agency, demonstrating equivalency to the Program Eligibility requirements (1, 2, & 3). 5. One Statement of Interest, submitted with your application, explaining why you are interested in the program. Topic below: Write a Statement of Interest that explains why you would like to complete the Bachelor of Science degree in Biomanufacturing. In this essay, state how your background in the prerequisite courses and/or any job experience has prepared you to succeed in this rigorous program. Emphasize your laboratory background. Include any life experience, special circumstances or barriers that you had to overcome while completing the 6. Submit unofficial Transcripts 7. For additional application and acceptance information go to https://welcome.solano.edu/ biomanufacturing/ Biotechnology Industrial Biotechnology Associate in Science Program Description This program prepares graduates to work in the biotechnology industry as production technicians. A production technician operates and maintains the equipment used to manufacture protein pharmaceuticals or other products. Students will grow bacterial, yeast, and mammalian cells and recover the proteins that they produce. They will follow good manufacturing practices by maintaining records in order to comply with quality assurance procedures and government regulations. Students in the program must be able to adjust their time to a flexible schedule. The Associate in Science can be obtained upon completion of the 22-24 unit major, General Education, and electives as needed to complete a minimum of 60 units. All courses in the major must be completed with a minimum grade of C or a P if the course is taken on a Pass/No Pass basis. Program Outcomes Students who complete the Industrial Biotechnology Associate in Science will be able to: 1. Explain how the structure and function of protein pharmaceuticals and evaluate which protein properties a production facility can exploit to purify a particular protein from other cellular components. 2. Construct a pathway analyzing how a drug or biologic is produced by genetically engineered cells and subsequently purified. 3. Explain how the manufacturer of pharmaceuticals is regulated by the Food and Drug Administration and other international regulatory agencies and how quality systems assure the safety, purity, identity, consistency, potency, and stability of a product. REQUIRED COURSES................................................Units BIOT 001 Principles of Biotechnology............................. 3 BIOT 052 Business, Regulatory and Quality Practices in Biotechnology......................................................... 3 BIOT 062 Cell Culture and Protein Recovery................... 4 BIOT 063 Biotechnology Instrumentation: Quality Control & Genetic Engineering....................... 4 Select Option A or Option B.......................................8-10 Required Major Total Units. ...............................22-24 Option A....................................................................Units BIO 002 Principles of Cell and Molecular Biology. ........... 5 CHEM 001 General Chemistry I....................................... 5 Option B....................................................................Units BIO 014 Principles of Microbiology................................. 4 CHEM 010 Intermediate Chemistry................................. 4 Consult with your counselor for guidance on custom course pathway Biotechnology Industrial Biotechnology Certificate of Achievement Program Description This program prepares graduates to work in the biotechnology industry as production technicians. A production technician operates and maintains the equipment used to manufacture protein pharmaceuticals and other products. Students will grow bacterial, yeast, and mammalian cells and recover the proteins that they produce. They will follow good manufacturing practices by maintaining records in order to comply with quality assurance procedures and government regulations. Students in the program must be able to adjust their time to a flexible schedule. The Certificate of Achievement can be obtained upon completion of the 18-24-unit major. Each course must be completed with a minimum grade of C or a P if the course is taken on a Pass/No Pass basis. Program Outcomes Students who complete the Industrial Biotechnology Certificate of Achievement will be able to: 1. Explain how the structure and function of protein pharmaceuticals and evaluate which protein properties a production facility can exploit to purify a particular protein from other cellular components. 2. In preparation to working at a biotechnology company, a successful student should be able to construct a pathway analyzing how a drug of biologic is produced by genetically engineered cells and subsequently purified. 3. Explain how the manufacturer of pharmaceuticals is regulated by the Food and Drug Administration and other international agencies and how quality systems assure the safety, purity, identity, consistency, potency, and stability of a product. REQUIRED COURSES................................................Units BIOT 001 Principles of Biotechnology............................. 3 BIOT 052 Business, Regulatory and quality Practices in Biotechnology......................................................... 3 BIOT 062 Cell Culture and Protein Recovery................... 4 BIOT 063 Biotechnology Instrumentation: Quality Control & Genetic Engineering....................... 4 Choose Option A, B or C ............................................4-10 Required Major Total Units. ...............................18-24 Option A....................................................................Units BIO 002 Principles of Cell and Molecular Biology. ........... 5 CHEM 001 General Chemistry I....................................... 5 Option B (complete BIO 014 and 1 CHEM) ..............Units BIO 014 Principles of Microbiology................................. 4 Option B Chemistry (select one) CHEM 010 Intermediate Chemistry............................ 4 CHEM 012 Chemistry for the Health Sciences............ 5 Option C (select one course)....................................Units BIOT 010 Introductory Biotechnology............................. 4 BIOT 160 Basic Concepts/Methods in Biotechnology............................................................. 4 Consult with your counselor for guidance on custom course pathway Biotechnology Biotechnology Laboratory Assistant Certificate of Achievement Program Description This program serves as a Bridge to Biosciences, enabling graduates to enter the Solano College Industrial Biotechnology program or to enter an entry level position in a biotechnology company. It serves as a stackable certificate that may be followed by Industrial Biotechnology Certificate. A Laboratory Assistant may be hired by life science related companies to prepare buffers, prepare media, operate routine laboratory equipment, and to clean glassware. The Certificate of Achievement can be obtained upon completion of the 12-14-unit major with a minimum grade of C or a P if the course is taken on a Pass/No Pass basis. Program Outcomes Students who complete the Biotechnology Laboratory Certificate of Achievement will be able to: 1.Demonstrate the ability to perform mathematical (algebraic) operations required for calculations important in chemistry and biology 2. Demonstrate the ability to read and write in a range of writing style categories typical of laboratory and scholarly environments, including lab reports, expository texts, and research-based arguments. 3.Demonstrate the ability to perform routine laboratory techniques including buffer preparation, media preparation, and aseptic microbial culture. REQUIRED COURSES................................................Units English (select one course)........................................... 4-5 ENGL C1000 Academic Reading and Writing................... 4 ENGL 001E College Composition for Non-native English Speakers ...................................... 5 Mathematics (select one course).................................3-4 STAT C1000 Introduction to Statistics ............................. 4 MATH 012 Mathematical Ideas ...................................... 3 Biotechnology (select one course).................................. 4 BIOT 160 Basic Concepts/Methods in Biotechnology..... 4 BIOT 010 Introductory Biotechnology ............................ 4 Learning Resources ........................................................ 1 LR010 - Information Skills for College and Beyond ......... 1 Total Units: ................................................................14 Consult with your counselor for guidance on custom course pathway Biotechnology Cell and Gene Therapies Certificate of Achievement Program Description This program trains students to enter the emerging fields of gene therapy (with the production of viral vectors) and cell therapy including the production of CAR-T cells as a cancer therapy and stems cells for use in regenerative medicine. The Certificate of Achievement can be obtained by completing the 24-29-unit major. All courses must be completed with a minimum grade of C or a grade of P if the course is taken on a Pass/No Pass basis. Program Outcomes Students who complete the Stem Cells and Cell-Based Technologies Certificate of Achievement will be able to: 1. Apply knowledge of the regulation of the Food and Drug Administration and other international regulatory agencies of cell-based therapeutic agents. 2. Apply knowledge of cell biology concepts to prepare and maintain cells in culture while maintaining sterility stem cells must be able to be cultured in an undifferentiated state or induced to differentiate into different cell types. 3. Follow the appropriate procedures to maintain controlled documents: In a research setting, students will keep a research laboratory notebook using a standard legal format. In a manufacturing setting, students will keep the appropriate controlled documents REQUIRED COURSES...............................................Units BIOT 001 Principles of Biotechnology............................. 3 BIOT 052 Business and Regulatory Practices in Biotechnology............................................................ 3 BIOT 057 Synthetic Biology and Algae Biotechnology..... 3 BIOT 060 Mammalian Cell Culture ................................. 3 BIOT 061 Stem Cells and Cell-Based Technologies ......... 3 One course from Biomanufacturing List.......................1-4 One course from Biology List. .......................................4-5 One course from the Chemistry List ............................4-5 Total Units: .......................................................24-29 Biomanufacturing: ................................................ Units BIOT 062 Cell Culture and Protein Recovery................... 4 BIOT 065 Biomanufacturing Fundamentals .................... 1 Biology.................................................................. Units BIO 002 Cell and Molecular Biology............................... 5 BIO 014 Principles of Microbiology ................................ 4 Chemistry.............................................................. Units CHEM 001 General Chemistry........................................ 5 CHEM 010 Intermediate Chemistry ................................ 4 CHEM 012 Chemistry for the Health Sciences ................ 5 Consult with your counselor for guidance on custom course pathway BIOT - Biotechnology 