MOUNT WACHUSETT COMMUNITY COLLEGE DEVENS, MASSACHUSETTS. COURSE SYLLABUS Fall Semester 2010

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1 MOUNT WACHUSETT COMMUNITY COLLEGE DEVENS, MASSACHUSETTS COURSE SYLLABUS Fall Semester 2010 COURSE: TEXT: BTC120 Biotechnology Experience II: Biomanufacturing (4 credits) Industrial Biotechnology: A Training Manual, Moorpark College Code of Federal Regulations Part 210 and 211 (provided in class) Assorted additional readings (provided on Blackboard) LAB MANUAL: Global Biomanufacturing Curriculum, Mount Wachusett Community College Biotechnology Laboratory Manual Northeast Biomanufacturing Center and Collaborative (provided in class) INSTRUCTOR: OFFICE HOURS: COURSE DESCRIPTION: The second of two experiential courses, the course begins by introducing the student to the proteins and companies of biotechnology and to CGMP (current good manufacturing practices). In the remainder of the course students use bacteria, mammalian and yeast cells to produce human proteins using tools and standard manufacturing operating procedures of biotechnology, including upstream and downstream processing of proteins and quality control of protein production. COURSE OBJECTIVES: At the end of the semester, students will: 1. Understand the various jobs opportunities in a biomanufacturing plant. 2. Understand the importance of cgmp, including the history of the development of the FDA and cgmp. 3. Understand and adhere to documentation guidelines of cgmp. 4. Be able to routinely monitor the environment for particle count and viable microorganisms. 5. Be able to grow mammalian cells, monitor their growth, generate growth curves and calculate growth rates. 6. Be able to purify a protein using filtration and chromatography techniques. 7. Be able to evaluate protein production, purity and activity with ELISA and SDS PAGE. 8. Be able to evaluate samples for contamination by using Gram stain, LAL and mycoplasma detection assays.

2 9. Be able to understand the importance of training records and to maintain training records. 10. Be familiar with basic operating procedures in any lab, including safety, documentation, experimental design, and data analysis and reporting. 11. Be able to demonstrate the ability to write and speak effectively through written assignments, lab reports and discussions. METHODS OF INSTRUCTION: This course will be taught using lectures supplemented with visual overheads and handouts when appropriate. Blackboard will also be used for lecture support and information. Films, computers and models may be used when their content is relevant to course topics. Course topics will be covered in lecture, class discussions, class activities and laboratory experimentation providing students with exposure to the topics multiple times. The students will contribute to their learning by actively engaging in classroom activities as well as online activities. Students will have opportunities to work with each other in small groups and class discussions. ATTENDANCE POLICY: Attendance is expected at ALL classes and laboratory sessions. There is a close correlation between attendance and student success. The college makes no distinction between excused and unexcused absences. If a student is not present in class, they are absent, regardless of the reason. Students are responsible for all material covered during an absence, including class notes, handouts, assignments and submitting assignments on time. At the discretion of the instructor, any student who stops attending class during the course of the semester without officially withdrawing from the course will receive a final grade of F. GRADING POLICY: The assignment of a course grade will be based on the following: The assignment of grades is based on the absolute scale below: A = C = A- = C- = B+ = D+ = B = D = B- = D- = C+ = F = CLASS COMPONENT: Exams: o One exam will be given during the semester (refer to schedule for date). This exam will be a mix of multiple choice, fill in the blank, true/false and short answer. o The final exam will be comprehensive. The format will be the same as the other exam. o To be fair and consistent with all students and to maintain standards, a student may be allowed to make up the mid-term exam. The missed exam must be made up within 5 days, at a time mutually convenient to the instructor and student. It is the responsibility of the student to contact the instructor within 24

3 hours of missing an exam to request a makeup. Failure to make up this work in the allotted time will result in a grade of 0 for that exam. The makeup exam may be a different format than the original exam. o A missed final exam without prior discussion/arrangement with the instructor will result in an F on that exam with no makeup allowed. Extra Credit. Requests from students for special projects to improve grades are not appropriate. There is no provision for extra credit when course outcomes are not being achieved. Cell Phones and other electronic devices must be silenced during class and lab. Interruptions from these devices will not be tolerated. LABORATORY COMPONENT: The laboratory component of this course provides students with basic skills used in biomanufacturing. The experiments performed will enhance and reflect the material that is covered in lecture. Laboratory coats are required; you are responsible for purchasing your own lab coat. Missed Labs Since many laboratory experiments are complex, require considerable preparation time and are unable to be duplicated, students CANNOT make up missed labs. Time Requirements Biomanufacturing protocols often have multiple components that require incubation periods. Therefore it may be necessary to come back to the lab the next day to finish the experiment. We may also use some of the lecture time to finish an experiment. Policy on Children in the Laboratory For the health and safety of everyone, be aware that children are never allowed in the laboratory at MWCC under any circumstances. This policy applies to everyone. Laboratory Exam There will be one laboratory exam at the end of the semester. It will be a mixture of theoretical questions and practical questions. If you need an SOP to run an instrument, it will be provided. Laboratory Reports There will be pre-lab and post-lab reports. Both will be posted on Blackboard one week prior to lab. It is your responsibility to get the lab reports from Blackboard, answer the questions, and turn them in. Pre-lab reports are due the day of lab. Post-lab reports will be due one week after the lab. Late lab reports will not be accepted. MWCC Disability Statement: Students with documented disabilities who believe that they may need accommodations in this class are encouraged to contact Julie Crowley, Director of the Devens campus at (978) or j_crowley@mwcc.mass.edu. Students may also contact the Counselor for Students with Disabilities at the main Campus. To speak with the Counselor for day students, call (978) Please contact them as soon as possible to ensure that such accommodations are implemented in a timely fashion. Notice of Non-discrimination Mount Wachusett Community College is an affirmative action/equal opportunity employer and does not discriminate on the basis of race, color, religious creed, age, physical or mental disability, sex, national origin or ancestry, marital status, sexual orientation, genetic information

4 or veteran status. This policy incorporates by reference and where applicable, the requirements of Federal Executive Orders and as amended; the Civil Rights Act of 1964 as amended; the Civil Rights Restoration Act of 1988; the Civil Rights Act of 1991; Title IX of the Higher Education Amendments of 1972 as amended; Sections 503 and 504 of the Rehabilitation Act of 1973; the Americans with Disabilities Act of 1990; Section 402 of the Vietnam Era Veterans Readjustment Assistance Act of 1974; and pertinent laws, regulations and executive orders; directives of the Board of Higher Education, the Boards of Trustees of the Community Colleges and the Commonwealth of Massachusetts, and other applicable local, state and federal statutes. The following persons have been designated for inquiries regarding non-discrimination programs and policies: Diane Ruksnaitis, Officer, Affirmative Action Nancy Kennedy, Director of Counseling, Coordinator, American Disabilities Act Donna Thibault, Coordinator for Students with Disabilities Counselor and 504 Coordinator, 444 Green Street, Gardner, MA Telephone: Voice (978) ; TTY: (978) Academic Support Center Many students find that college coursework provides new academic challenges. Students who wish to deepen their understanding of course concepts, extend their skills, and improve performance in this course are encouraged to use the free tutoring and other support services available in the Academic Support Center. Writing and math tutoring is available on a drop in basis; tutoring in other subjects is arranged by appointment. Stop by the Center in Room 116 or phone them at You will also find valuable resources on their web site: TENTATIVE COURSE SCHEDULE Fall 2010 Date Class Lab Sept.7 Overview of the structure of the course Introduction to Biomanufacturing 9 Validation/Calibration David Hyde 14 Metrology - Tour of Lab Scale Biomanufacturing Lab Calibrate balances, ph meters and pipettes

5 16 Validation/Calibration Davide Hyde 21 Validation 23 Quality Assurance cgmp Popcorn exercise 28 Quality Assurance documentation exercises 30 Environmental Health and Safety Oct.5 Quality Control Microbiology EH&S Biomanufacturing Lab Safety Check MSDS file location Chemical Inventory List 7 Quality Control Microbiology Settle plates and dab plates Microbial air testing Gram Staining 12 Quality Control Mycoplasma testing (PCR) 14 Production Overview LAL ELISA assay 19 Midterm Exam 21 Aspetic Technique Biosafety cabinet Introduction to bioreactor parts of bioreactor assemble and calibrate ph probe inoculate with water 26 Biosafety cabinet Introduction to bioreactor parts of bioreactor assemble and calibrate ph probe inoculate with water 28 Upstream Processing Edwin Introduction to bioreactor Smith, BMS sampling and testing Nov.2 CHO tpa Core Production System Make CHO media Spinner flasks media hold 3 Wednesday CHO tpa Core Production System Check media hold spinner flasks Inoculate spinner flasks (time zero testing) 4 CHO tpa Core Production System Spinner flasks (time 1 testing) 5 Friday CHO tpa Core Production System Spinner flasks (time 2 testing) Bioreactor media hold

6 8 Monday CHO tpa Core Production System Spinner flasks (time 5 testing) Inoculate bioreactor (time zero testing) 9 CHO tpa Core Production System Time 1 bioreactor testing 10 Wednesday CHO tpa Core Production System Time 2 bioreactor testing 11 Holiday no class 12 Friday CHO tpa Core Production System Time 3 bioreactor testing harvest 16 Harvest and Cell Banking CHO tpa Core Production System Cell banking 18 Downstream Processing Don Gibbs, BMS 23 Review Column Chromatography results 25 Thanksgiving no class Column chromatography Bio-Rad starter kit 30 Purification of tpa Ion exchange chromatography Dec.2 Quality Control Biochemistry tpa production assay SDS PAGE of purified tpa 7 Quality Control Biochemistry 9 tpa production assay tpa ELISA 14 Review tpa ELISA results 16 Lab Exam 21 Final Exam Reading Assignments Week 1 Overview of Biotechnology A Short History of Biotechnology Biotechnology Companies Industrial Biotechnology Section 38

7 Week 2 Industrial Biotechnology Section 1, 2, 3, 35, 37 Week 3 cgmp: The Regulatory Environment for Biological Pharmaceutical Manufacturing A Brief History of the GMP s The Power of Storytelling Industrial Biotechnology Sections 6, 7, 10 Week 4 Introduction to Animal Cell Culture Understanding and Managing Cell Culture Contamination The Mathematics Behind Growth Industrial Biotechnology Sections 5, 11, 17, 22 Week 5 Media Buffer and Reagent Preparation Principles of Upstream Processing Cells Endotoxins and Cell Culture Industrial Biotechnology Sections 13, 18, 20, 30 Week 6 Bioreactors Industrial Biotechnology Sections 14, 15, 16 Week 7 General Guide for Cryogenically Storing Animal Cell Cultures Week 8 Industrial Biotechnology Sections 26, 31 Week 9 Principles of Downstream Processing Week The Future of Transgenics 10 Week Protein Concentration and Diafiltration by TFF 11 Industrial Biotechnology Sections 24 Week Purification by Liquid Chromatography 12 Industrial Biotechnology Sections 27, 34 Week 13 Industrial Biotechnology Section 28