Syllabus for Pharmaceutical Bioprocessing (PhB) 610
course
Biotech-Biopharmaceutical Processes and Products
Wednesdays, 6:00 - 9:00 pm
General King Building Rm 316
The course covers different types of biopharmaceutical/biotech/biological products and the processes used to produce them. Related topics such as expression system choice/engineering, product design and regulatory considerations will also be addressed.
instructor and contact information
Jason Saunders
(732)236-8219 (mobile)
office hours
Generally, office hours will be by appointment on Wednesdays 4:30 - 5:45 pm.
There is flexibility for cases where the above does not match people’s needs.
course material: class notes and readings
The information and ideas presented in the course will be drawn from a variety of technical sources. The main one being:
Walsh G. 2007. Pharmaceutical Biotechnology: Concepts and Applications. John Wiley & Sons. Saddle River, NJ.
I will post a pdf copy of the above text book on Moodle. I also will be regularly posting slide decks, journal articles and other book sections on Moodle as needed, prior to a given week’s class. All examand quiz questions will be based on information delivered during lecture.
The material covered in this course is largely qualitative, although some biotechnology-relevant calculations will be included. All of the information that is presented during lecture can be found in the presented slide decks and reading assignments.
grade determination
2 examinations (in-class/closed book--35% each), 5quizzes (drop lowest score for 5% each) and an in-class presentation of a journal article (10%).
Examinations will consist of a midterm and final, both cumulative. Quizzes will be based on a basic understanding of material from previous lectures and assigned readings. Presentations will occur in after the mid-term, the scheduling/grading criteria will be reviewed (TBD). A pre-determined grading scale will not be given as I base final grades on relative performance and natural groupings.
class attendance
As for all graduate courses at NJIT, attendance is not mandatory, but strongly recommended. As described above, vast majority of the knowledge to be tested in quizzes and exams will come from lecture notes.
NJIT Honor Code
The NJIT honor code is being upheld on all issues related to the course. Students are expected to be familiar with the code and conduct themselves accordingly.
important dates from University’s Fall 2017 Academic Calendar
September / 4 / Monday / Labor DaySeptember / 5 / Tuesday / First Day of Classes
September / 9 / Saturday / Saturday Classes Begin
September / 11 / Monday / Last Day to Add/Drop a Class
September / 11 / Monday / Last Day for 100% Refund, Full or Partial
September / 12 / Tuesday / W Grades Posted for Course Withdrawals
September / 18 / Monday / Last Day for 90% Refund, Full/Partial Withdrawal
October / 2 / Monday / Last Day for 50% Refund, Full Withdrawal
October / 23 / Monday / Last day for 25% Refund, Full Withdrawal
November / 6 / Monday / Last Day to Withdraw
November / 21 / Tuesday / Thursday Classes Meet
November / 22 / Wednesday / Friday Classes Meet
November / 23 / Thursday / Thanksgiving Recess Begins
November / 26 / Sunday / Thanksgiving Recess Ends
December / 13 / Wednesday / Last Day of Classes
December / 14 / Thursday / Reading Day
December / 15 / Friday / Final Exams Begin
December / 21 / Thursday / Final Exams End
December / 23 / Saturday / Final Grades Due
Lecture schedule
week / Date / Topic1 / 06-Sep-17 / meet and greet, course overview, biopharma. background (Ch 1)
2 / 13-Sep-17 / Molecular & Cell Biology In Biotechnology (Ch2,3 Walsh 2007)
Primary Biopharmacuetical Expression Systems (Review articles)
3 / 20-Sep-17 / Quiz
Finalize Oral presentation
4 / 27-Sep-17 / Biopharma. Process Development
Upstream and Downstream operations; production, product recovery and characterization (5,6, 7 Walsh 2007+ Review articles)
5 / 04-Oct-17 / Quiz
Drug development process (Ch 4); drug PK/PD, omics, patenting, regulatory filing, etc.
Therapeutic hormones (Ch 11 Walsh 2007 and Review articles):
Insulin as paradigm; diabetes biology, insulin products & protein engineering-amino acid sequence level, upstream/downstream process for insulin
6 / 11-Oct-17 / Fusion/therapeutic proteins (Ch 5)
Product engineering-Protein design (review articles)
Enbrel as paradigm
Cut-off for the mid-term
7 / 18-Oct-17 / Quiz
Therapeuticantibodies (Ch 13 + Review articles): mAb Structure, The biology behind immune-oncology products, and chronic inflammation disease, T-cell engaging bi-specifics (other types of bispecific antibodies), CAR-T
Mid-term questions/review
8 / 25-Oct-17 / mid-term examination
9 / 01-Nov-17 / Mab part 2 , Development process for therapeutic antibodies (General Upstream and Downstream/Product Characterization) (Ch 13)
10 / 08-Nov-17 / Quiz
Antibiotics (review articles)
11 / 15-Nov-17 / Cytokines; interferon, IntronA, BMP, GCSF (Ch 8-9+review articles)
12 / 22-Nov-17 / No class –NJIT Classes follow Friday schedule.
13 / 29-Nov-17 / Growth factors (Ch. 10)
14 / 06-Dec-17 / Quiz
blood products (Ch 12), nucleic acid / cell based therapeutics, CAR-T (Ch. 14)
15 / 13-Dec-17 / vaccines (Ch 13),
16 / 20-Dec-17 / final examination