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Course Code: 
PHAR 422
Course Period: 
Spring
Course Type: 
Core
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Objectives: 
To provide information on fundamental concepts of pharmaceutical biotechnology and its application areas to undergraduate students .
Course Content: 

Introduction to biotechnology; the role of biotechnology in drug development and production, related basic concepts and applications;  isolation and purification of macromolecules;  nucleic acid amplification methods and their use in biotechnology; recombinant DNA technology and its applications in the field of pharmacy; hybridoma technology and monoclonal antibody production; antisense technology and applications; gene therapy and gene delivery systems; cell-based therapy; physicochemical properties of biopharmaceuticals and their formulation; microbial transformation techniques for the biosynthesis of corticosteroids, and their possible role in drugs development; plant tissue and organ culture techniques in the production of active drug substance; fermentation techniques and their applications in pharmaceutical industry; biologics, vaccines and serums.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme learning outcomes

Teaching Methods

Assessment Methods

1) Learn the main concepts and definitions in Biotechnology.

2, 4, 7, 8, 10

1, 2, 3, 4

A,B,C,D, G, H

2) Instruct the importance and main application areas of Biotechnology in human life.

2, 4, 7, 8, 10

1, 2, 3, 4

A,B,C,D, G, H

3) Teach the importance of Biotechnogy in Pharmaceutical practices.

2, 4, 7, 8, 10

1, 2, 3, 4

A,B,C,D, G, H

4) Instruct the pharmaceutical applications of Gen therapy, Recombinant DNA technology etc. 

2, 4, 7, 8, 10

1, 2, 3, 4

A,B,C,D, G, H

5) Instruct the production techniques of vaccines and Serums.

2, 4, 7, 8, 10

1, 2, 3, 4

A,B,C,D, G, H

 
 

Course Flow

Week

Topics

Study Materials

1

Introduction to biotechnology, branches of biotechnology, biosafety, introduction to pharmaceutical biotechnology.

Handout of PPP,

References

2

Cell macromolecules, (nucleic acids, proteins, membrane lipids) disruption of cells and purification of macromolecules with chromatographic techniques (gel electrophoresis, gel filtration, affinity chromatography).

Handout of PPP,

References

3

Intorduction to PCR (Polymerase Chain Reaction), steps in PCR, real time-PCR, applications of PCR and real time-PCR

Handout of PPP,

References

4

Recombinant DNA Technology: Steps in production of recombinant  DNA, its expression systems, transgenic plants and animals, examples of approved recombinant protein drugs.

Handout of PPP,

References

5

Hybridoma Technology: Definitions of poly- and mono-clonal antibody, method of producing murine, human, chimeric, humanized monoclonal antibody, applications of monoclonal antibody.

Handout of PPP,

References

6

Antisense Technology: Definition, comparison of antisense product to traditional drugs, types of antisense products and their mechanism of action.

Handout of PPP,

References

7

Gene Therapy: Gene & gene therapy, types of gene therapy, reasons for lack of  success in gene therapy, safety consideration, practical approaches to gene delivery to cells, gene therapy situation for certain specific diseases- genetic or acquired diseases, diabetes, nervous system disorders, cancer,

AIDS, gene therapy-based vaccines.

Handout of PPP,

References

8

Gene Therapy: Viral vectors- retrovirus, adenovirus, adeno-associated virus, herpes simplex virus and sindbis virus as gene vectors; nonviral vectors- need for nonviral vectors, “nanoporters”, gene guns, electroporation, sonoporation, lipoplexes and polyplexes as nonviral vectors; chimmeric vectors.

Handout of PPP,

References

9

Midterm exam

Handout of PPP,

References

10

Fermentation teknology; main concepts, definitions, application areas.

Handout of PPP,

References

11

Plant cell/tissue culture techniques and applications in drugs production.

Handout of PPP,

References

12

Microbiological transformation

Handout of PPP,

References

13

Antibiotic production

Handout of PPP,

References

14

Vaccines and Sera

Handout of PPP,

References

15

Patenting and registration of the Biotechnological products.

 

16

Questions and answers

 
 
 

Recommended Sources

Textbook

1. Michael J. Groves. Pharmaceutical Biotechnology, Second Edition, CRC Press Taylor & Francis Group, 2006.

2. Gary Walsh. Biopharmaceuticals : biochemistry and biotechnology, Second Edition, J. Wiley , 2003.

3. Lecture Notes

Additional Resources

 
 
 

Material Sharing

Documents

 

Assignments

 

Exams

 
 
 

Assessment

IN-TERM STUDIES

NUMBER

PERCENTAGE

Mid-terms

1

80

Quiz(zes)

0

0

Assignment

2

20

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

60

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

40

Total

 

100

 

 

COURSE CATEGORY

Undergraduate Courses

 
 

Course’s Contribution to Program

COURSE'S CONTRIBUTION TO PROGRAM

No

Program Learning Outcomes

Contribution

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

         

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

     

X

 

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

         

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

       

X

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

         

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

         

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner .

     

X

 

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

       

X

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

         

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

       

X

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

         

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

         

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

         

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

         
             
 
 

ECTS

Activities

Quantity

Duration
(Hour)

Total
Workload
(Hour)

Course Duration (Including the exam week: 16x course hours)

16

2

32

Hours for off-the-classroom study (Pre-study, practice)

16

2

32

Quiz(zes)

0

0

0

Mid-term(s)

1

1

1

Ödev

2

3

6

Final examination

1

4

4

Total Work Load

   

76

Total Work Load / 25 (h)

 

 

3.01

ECTS Credit of the Course

 

 

3