COURSE OUTLINE
Kulliyyah
Department
Pharmacy
Pharmaceutical Technology
Programme
B. Pharm.
Course Title
Pharmaceutical Biotechnology
Course Code
2232
Level
2000 (year 2)
Credit Hours
2
Contact hours
L = 20h, P = 3x3, T = 6h. Total = 35 hours
Pre-requisites
Nil
Co-requisites
Nil
Teaching Methodology
Lectures
Tutorial
Laboratory (Practicals)
Demonstration
Mid semester examination
MCQs
10 questions
Duration: 20 minutes
Methods of Evaluation
Short essays
Long essays
Duration: 1 hour.
2 of 3 questions
1 of 2 questions
40%
10%
15%
15%
End semester examination
60%
Laboratory Report
10%
MCQs
Duration
20%
20 questions
30 minutes
Short essays 3 out of 4 questions
Long essays 1 out of 2 questions
Duration: 1 hour 30 minutes
1
15%
15%
Course Coordinator:
Assist Prof. Dr. Nasreldin Elhadi Hussein
Instructors:
Prof. Dr. Omar Hasan Kasule
Assist Prof. Dr. May Khin Soe
2
The course aims exposing students to various topics in
biotechnology, including the pharmacist’s role in
biotechnology, criteria for regulatory approval for
biotechnology drugs, technology in genetic engineering and
its application to pharmacy and tissue culture. Students will
also be exposed to methods in producing commercial products
using fermentation biotechnology. This course will also
discuss the clinical, epidemiological, economical and ethical
aspects of the use of biotechnological drugs.
Semester offered
Course Objectives
Course Synopsis
Course Outlines
The application of Biotechnology procedures in the field of
Pharmacy. Aside from its obvious influence on the practice of
medicine, the adoption of biotechnology effects the structure
of the healthcare system. Techniques such as DNA probes and
monoclonal antibodies, which facilitate faster diagnosis of
disease, and therapies that effect quicker recovery illness will
shorten hospital stays. Biotechnology will change the profile
of the major causes of death and disability in our society. The
over all impact of technological innovations on the health care
system is difficult to predict because of the counteracting
effects of different technologies on the system and because of
uncertainty regarding the extent of technology adoption.
Adoption will depend on the interplay among the economic,
epidemiology, health manpower and resources, lifestyle and
regulatory responses of society, as well as the ethical issues
surrounding the use of medical technology.
i)
ii)
iii)
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v)
vi)
Introduction to Biotechnology
The Pharmacist’s Role and Criteria for Regulatory
Approval for Biotechnology drugs.
Genetic Engineering
Tissue Culture
Fermentation Technology
Clinical, Epidemiological, Economical and Ethical
Aspects of the use of Biotechnological Drugs.
2
Weeks
1
Topic
Introduction to Biotechnology:
What is Biotechnology?
Why do we need Biotechnology?
Where we apply Biotechnology?
Overview of new technology
Biotechnology new solution for old problem
Better health and Nutrition
Genetically modified food (GMF)
Carriers in Biotechnology
Asst. Prof. Dr. Nasreldin
Ref 1, Pharmaceutical
Society Website, p. 1-10
Ref , Chap. 28, 622- 623
Ref, Chap. 1, 1 - 13
Practical 1: Bacterial Genomic DNA Extraction
Asst. Prof. Dr. Nasreldin
2
Biotechnology and the Pharmacist:
The process of recombinant DNA technology
The hybridoma technology
Basic sited-directed mutagenesis
Products of biotechnology
Diagnostic products
Criteria for regulatory approval of biotechnology
The pharmacist’s role in biotechnology
Asst. Prof. Dr. Nasreldin
Ref 1, Pharmaceutical
Society Website, p. 1-10
3
Practical 2: Plasmid DNA Extraction
Asst. Prof. Dr. Nasreldin
Genetic Engineering I:
DNA as the primary genetic material
Central Dogma of Molecular Biology
Protein and its structure
DNA, RNA and its structure
Transcription and translation, genetic code
Asst. Prof. Dr May Khin
Ref, Chap. 45 - 72
Ref, Chap. 11, 119 - 141
DNA Cloning and Methods of creating
Recombinant DNA molecules
Definition of cloning within the molecular
genetic context.
Purposes in cloning
Enzymes for cloning
Restriction enzymes
Bacterial strains
Plasmid and bacteriophage vectors used for
cloning
Asst. Prof. Dr. Nasreldin
Ref, Chap. 11, 119 - 141
3
4
5
6
7
Genetic Engineering II:
Types of DNA library
Genomic Library
Complementary DNA (cDNA) library
Expression of cloned genes
Asst. Prof. Dr. Nasreldin
Ref, Chap. 45 - 72
Ref, Chap. 10, p. 227 - 249
Ref, Chap. 1, p. 1 - 16
Polymerase Chain Reaction (PCR)
Discuss the basics and fundamentals of PCR
Applications of PCR as a diagnostic tool and
DNA fingerprinting
Asst. Prof. Dr. Nasreldin
Ref, Chap. 17, p. 269 - 283
Genetic Engineering III:
Applications of Recombinant DNA in the
Pharmaceutical and Medical Fields.
A brief overview of the accomplishments of
recombinant DNA technology.
Development of genetically engineered
pharmaceutical products (insulin, human growth
hormone DNA vaccines).
Recombinant DNA techniques as tools for the
diagnosis and treatment of human disease.
Asst. Prof. Dr. May Khin
Ref, Chap. 28, p. 623 - 648
Ref, Chap. 45 - 72
Ref, Chap. 10, p. 227 - 249
Practical 3: Demonstration on PCR Protocol
Asst. Prof. Dr. Nasreldin
Tissue Culture I
Definition of tissue culture and trend of animal
research from whole animal to
tissue culture.
Types of tissue culture including organ culture,
explants culture, cell culture, continuous cell
line and characteristics of each type of tissue
culture.
Culture collection and resource centers eg.
American Type Culture Collection, European
Collection of Animal Cell Culture and Riken
Gene Bank.
Tissue Culture II
The origin of cell lines, replication and
differentiation of cells.
Examples of tissue culture:
Source of tissue
Embryonic, normal and neoplastic tissues with
examples
General materials, reagents and instruments
used in tissue culture technique.
Asst. Prof. Dr. Nasreldin
Ref 1, Chap 2, p 7 - 13
4
Asst. Prof. Dr. Nasreldin
Ref 1, Chap 2, p 7 - 13
Asst. Prof. Dr. Nasreldin
Ref, Chap. 21, p. 225
Re, Chap. 1, p. 1 - 6
8
Tissue Culture III
Application of tissue culture techniques
Brief examples of the preparation of liver cells
(hepatocytes).
Advantages and disadvantageous and
disadvantageous of tissue culture system
9
Fermentation Technology I
Fermented products:
Categories of biotechnology medicine:
Antisense, clotting factor, colony
stimulating factors, erythropoietins, human
growth hormones, interferons, interleukins,
monoclonal antibodies, vaccines.
Antibiotics: Penicillins, cephalosporins,
streptomycins, tetracyclines, aminoglycosides
and etc.
Intermediate products: Vitamins, amino acids
Asst. Prof. Dr. Nasreldin
Ref, Chap. 13, p. 305 - 325
Ref, Chap. 7, p. 155 - 171
10
Fermentation Technology II
Scale-up process (manufacturing of
commercial biotechnology product):
Inoculum: preparation and development of
inoculum for industrial fermentation.
Cell culture: optimization of the fermentation
process (pH, temperature, and oxygen
requirements).
Determination of the optimized feeding regimen
and biomass quantification.
Improvement of selected microorganism with
increased productivity of the fermented
products.
Asst. Prof. Dr. Nasreldin
11
Fermentation Technology III
Fermentation process:
Batch fomentors: Stirred tank reactors, bubble
columns, airlift reactors.
Design of reactors: stirrers, controllers, aeration,
temperature control.
Fed-batch fermentors
Continuous fermentors
Asst. Prof. Dr. Nasreldin
5
Ref, Chap. 3, p. 53 - 57
Ref, Chap. 16, 399 - 406
12
Clinical and Epidemiological Aspects:
What is gene therapy and how it works?
Genetic Diseases:Immune deficiencies, Cystic
fibrosis, Cancer, Familial hypercholesterolemia
Huntington’s disease
Examples of biotechnological products and their
indications, including the cost of drugs:
Erythropoietin for anemia
Growth hormone for human growth hormone
deficiency
Interferon alpha for hairy cell leukemia
History of biotechnological drugs
Asst. Prof. Dr. Dr. Nasreldin
Ref, Chap. 28, p. 623 - 648
Ref, Chap. 10, p. 227 - 249
Ref, Chap. 7, p. 167 – 181
13
Implications of Biotechnology Products:
Biotechnology in the healthcare system:
Health system
Quality of medical care
Ethical
Cost
Technology Assessment
Pharmaceutical industries
Pharmacy profession
Evaluation of biotechnology products:
The importance of pharmacoeconomic and life
studies
Patient counseling and education:
Scope of pharmacists activities and
responsibilities
Drug administration technique
Counseling steps and improving compliance
General and specific side effects of biotech
drugs
Asst. Prof. Dr. Nasreldin
Ref, Chap. 28, p. 623 – 648
6
Prof. Dr. Omar Kasule
14
Legal and Ethical Perspectives:
Genetic test and its importance
Prenatal genetic test
Amniocentesis technique
Chronic villus sampling technique
Genetic test for pre-symptomatic problem
Screening heck-up:thorough and frequent
Treatment: early
Discrimination
Stigmatization
Segregation
Double standard
Assessment of genetic technology:
It is likely that public policy issues will soon
arise from this area and these issues will be
profoundly intermix with several factors:
Religious (Islamic issues: Biotechnological
drugs and Genetically Modified Food)
Social, Economic, Cultural and Ideological
References
Required
1. Sindelar, R.D., (2002) Pharmaceutical Biotechnology,
New York: Taylor & Francis.
2. Crommelin D, J.A., (1998) Pharmaceutical Biotechnology:
An Introduction for Pharmacists and Pharmaceutical Scientist,
New York: Taylor & Francis.
3. Watson, J.D., Gillman, M, Witkowski, J. & Zoller, M. (1992)
Recombinant DNA, (2nd Ed.), Scientific American Books, Inc.
4. Prit, S.J, (1975) Principles of Microbe and Cell Cultivation.
Blackwell Scientific Publication.
5. Stewart, C.F & Fleming, R.A, (1989) Biotechnology products:
New opportunities and responsibilities for the pharmacist,
American Journal of Hospital Pharmacy.
6. M-J The, Human insulin: DNA technology’s first drug,
American Journal of Hospital Pharmacy (1989), 46(suppl2), S9S11.
Year 2003/2004 Semester 2
Proposed Start
Date (Semester)
Batch of students to Year 2003/2004. (All Batches)
be Affected
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