PBB814 - Biotechnology and Biopharmaceuticals
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| Last revision date | May 7, 2025 4:31:04 PM |
| Last review date | May 7, 2025 4:31:04 PM |
Subject Title
Biotechnology and Biopharmaceuticals
Subject Description
This subject is an introduction to biopharmaceuticals and the application of biotechnology to produce them. Emphasis is on the regulations affecting the development and manufacturing of biopharmaceuticals and how they differ from traditional pharmaceuticals. Topics include: basic principles of biotechnology, large scale biopharmaceutical manufacturing, major differences in the regulatory process between biopharmaceuticals and traditional pharmaceuticals, combination biologics and medical device biologics. Students also explore future technologies employed in the biopharmaceutical and biotechnology industry to develop novel products.
Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.
Learning Outcomes
Upon successful completion of this subject the student will be able to:
- Discuss the principles of biotechnology and biopharmaceuticals.
- Describe the processes involved in the production of biopharmaceuticals.
- Apply Canadian regulatory guidelinesand International Conference on Harmonization (ICH) practices to the production of biopharmaceuticals.
- Compare the submission processes for biopharmaceuticals and traditional drugs.
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Prepare specific components in the Quality Overall Summary (QOS) of a New Drug submission of a biopharmaceutical.
Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).
Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.
Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.
Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.
Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.
Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.
By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.
Prerequisite(s)
Co requisite
PRA700 - Introduction to Pharmaceutical Regulatory Affairs or coordinator permission
Topic Outline
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Introductions and Course Outline What are Biotechnology/Biopharmaceuticals Canadian Biotech/Biopharm Industry |
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Drug discovery process GMOs and Tissue Culturing |
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Upstream Microbial Fermentation Downstream Microbial Fermentation |
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Biologic CTD Submission Biologics QOS and PSFI |
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Canadian Biologic Regulations Manufacturing, Testing and GMP Differences Contamination Control Comparison of Eukaryotic and Prokaryotic Manufacturing Practices |
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ICH Lecture Effective Group Project Management Toxin and Toxoid Preparations |
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Industry Guest Speaker (Pending) |
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Group Project Preparation / Independent Study |
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Combination Biologics / Medical Device Regulations Combination Biologics / Medical Device Regulations |
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Group Knowledge Building Activity Discussing and Exploring ICH |
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Group Application and Understanding Activity ICH Practicum and Case Scenarios |
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Group Project Presentation 1 Group Project Presentation 2 |
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Group Project Presentation 3 Group Project Presentation 4 |
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Group Project Presentation 5 Reflection |
Mode of Instruction
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In Class/Online Virtual Classroom
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Prescribed Texts
Canada's Food and Drugs Act http://laws-lois.justice.gc.ca/eng/acts/F-27/index.html
To find out the cost of books and learning material go here.
Any courses not listed on the bookstore webpage do not require any resources for purchase. All resources will be provided by your instructor.
Reference Material
Biopharmaceuticals: Biochemistry and Biotechnology, 2nd Edition, 2003; Gary Walsh; J. Wiley and Sons ISBN # 978-0-470-84327-7 (On reserve in the library)
Student Progression and Promotion Policy
http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html
Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html
| A+ | 90% to 100% |
| A | 80% to 89% |
| B+ | 75% to 79% |
| B | 70% to 74% |
| C+ | 65% to 69% |
| C | 60% to 64% |
| D+ | 55% to 59% |
| D | 50% to 54% |
| F | 0% to 49% (Not a Pass) |
| OR | |
| EXC | Excellent |
| SAT | Satisfactory |
| UNSAT | Unsatisfactory |
For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices.
As stated in Academic Policy, a student must successfully complete all major segments of a subject in order to earn a passing grade. For further information on evaluation and academic standing, see a copy of Academic Policy, available at Seneca registration offices.
Modes of Evaluation
Assignments
- Assignments are due at the beginning of the class on which they are due.
- A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
- Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
- Assignments are to be prepared by computer.
Absenteeism and Exams
- Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
- Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date. Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence. Examinations missed without official documentation and approval result in a grade of zero.
- There are no deferred options for missed tests. The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components
English Proficiency
- All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.
Format for Assignments
- Students must use the standard, APA style for quoting sources. Help is available at: http://library.senecapolytechnic.ca
LAB COURSES
Laboratory Attendance
The laboratory component is essential and therefore it is strongly recommended that you attend all labs. Any missed labs must be supported with a legal document with three days of the lab. Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.
Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory. Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class. The student will receive no grade for the lab missed.
Grading is based on the following marking scheme:
Primarily lectures with in two independent assignments, midterm examination, one group project, and one in-class assignment.
| Assignment 1 (QA) | 15% |
| Midterm | 25% |
| Assignment 2 Part 1 ICH Summary (RA) | 5% |
| Assignment 2 Part 2 ICH Case Scenarios (RA) | 15% |
| Group Project | 15% |
| Final Assessment | 25% |
Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory. The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.
Cell Phone Usage:
As a courtesy to your fellow students and faculty, cell phones should remain turned off while in class. If, in the case of an emergency, the cell phone must remain on, please notify the teacher before class begins.
PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS