PBB814 - Biotechnology and Biopharmaceuticals

Outline info
Semester
School
Last revision date 2017-05-29 00:41:47.811
Last review date 2017-07-17 00:16:28.786


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:

  1. Discuss the principles of biotechnology and biopharmaceuticals.
  1. Describe the processes involved in the production of biopharmaceuticals.
  1. Apply Canadian regulatory guidelinesand International Conference on Harmonization (ICH) practices to the production of biopharmaceuticals.
  1. Compare the submission processes for biopharmaceuticals and traditional drugs.
  1. Prepare specific components in the Quality Overall Summary (QOS) of a New Drug submission of a biopharmaceutical.

     

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

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@senecacollege.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 Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
Co requisite

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or coordinator permission 

Topic Outline

 
Introductions and Course Outline
  What are Biotechnology/Biopharmaceuticals
       Canadian Biotech/Biopharm Industry
   Drug discovery process
   GMOs and Tissue Culturing
   Upstream Microbial Fermentation
   Downstream Microbial Fermentation
    Biologic CTD Submission         
   Biologics QOS and PSFI  
Canadian Biologic Regulations
  Manufacturing, Testing and GMP Differences
  Contamination Control
        Comparison of Eukaryotic and Prokaryotic                  
        Manufacturing Practices
            
 
   ICH Lecture
  Effective Group Project Management
   Toxin and Toxoid Preparations
  Industry Guest Speaker (Pending)      

 
  Group Project Preparation / Independent Study

 
  Combination Biologics / Medical Device
         Regulations
  Combination Biologics / Medical Device
         Regulations
 
  Group Knowledge Building Activity
         Discussing and Exploring ICH
      
 
  Group Application and Understanding Activity
         ICH Practicum and Case Scenarios

 
   Group Project Presentation 1
  Group Project Presentation 2   

 
  Group Project Presentation 3
  Group Project Presentation 4
  Group Project Presentation 5
  Reflection 
 


   
   

   








Mode of Instruction
Lectures, group discussions, case studies, guest speaker
Primarily lectures with in two independent assignments, midterm examination, one group project, and one in-class assignment.

Prescribed Texts
Canada's Food and Drugs Act http://laws-lois.justice.gc.ca/eng/acts/F-27/index.html

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) 

Promotion Policy

Grading Policy
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.senecacollege.ca/academic-policy) 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.senecacollege.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.

Contribution to learning environment 5% (2.5% + 2.5%)
(Peer to Peer Presentations and Evaluations)
Midterm examination 25%
Assignments: Take-home QA assignment 15%
In-class RA assignment 15%
Group project 40%
100%

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
 

Approved by: Denis Gravelle