PHM2172 - International Islamic University Malaysia

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Dec 1, 2012 (4 years and 11 months ago)

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INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

COURSE OUTLINE



Kulliyyah

Pharmacy

Department

Pharmaceutical Technology

Programme

B. Pharm.

Course Title

Pharmaceutical Biotechnology

Course Code

PHM 2
17
2

Status

Core Course

Level

2000 (Year 2)

Credit
Hours


2

Contact Hours

L =
18
h

P =
5x3
h

T =
4

h

Total =
37
CH


Pre
-
requisites

(if any)

PHM 1223 Pharmaceutical Microbiology

PHM 2113 Medi
c
al Biochemistry

Co
-
requisites

(if any)

Nil

Instructional

Strategies

Lectures

Tutorial

Laboratory (
Practical
)

Demo
nstration


Course
Assessment



LO

Method

%


Mid
-
Semester Exam


40

1,2,3,4


MCQs 10 Questions


10



Duration: 20 min


1,2,3,4


Short Essays
4

out of
5

questions


20

1,2,3,4


Long Essays 1 out of 2 questions


1
0



Duration:

1 hr

30 min
s



End
-
Semester Exam


45




3,4,5


OSPE (5 stations)


10

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Duration: 10 min


1
-
6


Short Essays 3 out of 4 questions


15

1
-
6


Long Essays 2 out of 4 questions


20



Duration: 1 hr 45 min







Pract
ical

Report


15


Instructor(s)

Dr.

Muhammad Taher

Dr
.

Wan Azizi Wan Sulaiman

Dr
.

Solachuddin A.J. Ichwan

Dr. Ret
no Andayani

Semester
Offered

2

Course Synopsis

The field of pharmaceutical biotechnology is evolving rapidly. A whole new
arsenal of prote
in pharmaceuticals is being produced by recombinant techniques
for cancer, viral infections, cardiovascular and hereditary disorders and other
diseases. In addition, scientists are confronted with new technologies such as
polymerase chain reactions, combin
atorial chemistry and gene therapy. This
course provides extensive coverage of both the basic science and the
applications of biotechnology
-
produced pharmaceuticals, with emphasis on
their clinical use.

Course
Objectives

The
aim of the
course
is
exposing

students to various topics in
pharmaceutical
biotechnology, including the
recombinant DNA technology
,

fermentation
technology, plants and animal cell cultures, vaccines and antibodies and

criteria
for regulatory approval for biotechnology drugs
.
Students
will also be exposed
to methods in

biotechnology
-
based therapeutics agents and formulation


Learning
Outcomes

At the end of the course, students should be able to

1.

Describe t
he
biotechnology
-
based therapeutic agents.


2.

Explain the formulation of biotechnolo
gy products.

3.

Discuss the technology in
recombinant DNA

and its application in
pharmaceutical industry.

4.

Explain the use of tissue culture approach in pharmaceutical industry.

5.

Describe various
methods

in producing commercial products using
fermentation biote
chnology.

6.

Discuss
t
he
theory,
clinical,
technological,

economical
and ethical
aspects of the use of biotechnological drugs

such as antibodies and
vaccines.




Content Outlines

Weeks


Topics

Task / Reading

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1

1







2


Introduction to
b
iotechnology
.

Basi
c concept of biotechnology, basic concept of
gene expression between prokaryotic and
eukaryotic organism, Pharmaceutical
biotechnology and its application in
pharmaceutical industry


Genetic engineering I:
DNA extraction
,
d
efinition of cloning within the m
olecular
genetic context, DNA cloning and methods of
creating recombinant DNA molecules


Glick
&
Pasternak (2003)

Chapter 2






Glick & Pasternak (2003
)

Chapter 4

Crommelin & Sindelar
(2002)

Chapter 1

2

1




2

Genetic engineering II:
Purposes in cloni
ng
,
enzymes
for cloning
, r
estriction enzymes
,

gene
transfer techniques.


Practical 1
:

DNA extraction


Glick & Pasternak (
2003
)

Chapter

4


Crommelin & Sindelar
(2002)

Chapter 1

3

1





2

Genetic
e
ngineering II
I
:

DNA fingerprinting
,
p
olymerase
c
hain
r
eacti
on (PCR)
,
basics and
fundamentals of PCR

and
applications
of PCR as
a diagnostic tool

and DNA sequencing method.


Tutorial 1


Glick & Pasternak (
2003
)

Chapter

5

Crommelin & Sindelar
(2002)

4


P
ractical 2
:
PCR analysis


5





1.

Practical 3
:

E
lectrophoresis



2.

Tutori
a
l


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6

1






2

Animal tissue culture I :
Introduction to tissue
and organ culture, setting up a cell culture
laboratory, standard cell culture techniques

Sub
-
culturing, measuring cell growth and
cloning.


Animal tissue culture II: E
stab
lishing a cell line

transformed cell line, cell lines from normal
tissues, banking the line.



Freshney (2005)

7

1





2

Plant Tissue Culture I:
Introduction to plant
cell culture, sterile technique and media

requirement
, initiation of in vitro plant cell

culture.


Plant Tissue Culture II:
Clonal propagation
(Micropropagation),
secondary product formed
by plant cell cultures


Dixon & Gonzales (1994)

8

1






2

Formulation of biotechnology products

General consideration on the formulation of
proteins and

peptides.

Application routes.



Practical 4
: Bacterial transformation


Kayser and Muller (2004)

Chapter 9


9

1





2

Analytical techniques for biotechnology
products




Tutorial
3

Groves (2006)

Chapter 6

10

1








2

Fermentation technology I:
Scale
-
up

process
(manufacturing of commercial biotechnology
product),
i
noculum: preparation and development
of inoculum for industrial fermentation. Cell
culture: optimization of the fermentation process
(pH, temperature, and oxygen requirements).



Fermentation t
echnology II
: Determination of
the optimized feeding regimen and biomass
quantification, improvement of selected
microorganism with increased productivity of the
fermented products.


Glick & Pasternak (2003
)

Chapter 16


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1







2


Fermentation technolo
gy III:
Fermentation
process, batch fermentation: stirred tank reactors,
bubble columns, airlift reactors. Design of
reactors: stirrers, controllers, aeration,
temperature control. Fed
-
batch fermentation.

Continuous fermentation


Practical 5/ Demonstratio
n
: Animal cell
culture


Glick & Pasternak (2003
)

Chapter 16


12

1

2

Vaccine

DNA vaccines




Kayser & Muller (2004)

Chapter 5

Glick & Pasternak (2003
)

Chapter 21


13

1




2

Biotechnology
-
based therapeutic agents
:

i
nterferon, hormone, enzymes and nucleic
a
cids


Tutorial
4



Glick & Pasternak (2003
)

Chapter 10

14

1






2

Challenges relating to the future of
pharmaceutical biotechnology

Examples of essential biopharmaceuticals.

Pharmacoeconomis and gene engineering.


Regulating the use of biotechnology

Regu
lation in recombinant DNA technology.



Groves (2006)

Chapter 15





Glick and Pasternak 2003)
Chapter 21

References

Required



Glick, B. R., & Pasternak, J. J. (2003
).
Molecular Biotechnology: Principles and

Application of Recombinant DNA

(2
nd

ed.). Wash
ington D.C.: ASM Press.

Groves, M.J. (2006).
Pharmaceutical Biotechnology

(2
nd

ed.).

Boca Raton: Taylor and Francis.

Kayser, O.
,

& Muller, R.H. (2004).
Pharmaceutical Biotechnology: Drug
Discovery

and Clinical Applications
. Weinheim: Wiley.


Recommende
d

Bryant, J., Baggot la Velle, L., & Serale, J. (2005).
Introduction to Bioetics
.
Chichester: John Wiley and Sons.

Crommelin, D.J.A., & Sindelar, R.D. (2002).
Pharmaceutical Biotechnology. An

Introduction for Pharmacist and Pharmaceutical Scientist
.

(2
nd

ed). London: Taylor and Francis.

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Dixon, R. A., & Gonzales, R. A. (1994).
Plant Tissue Culture
.

(2
nd

ed.). Oxford: Oxford University Press.

Freshney, R.I. (2005).
Culture of Animal Cells: A Manual Basic Technique
.

(5
th

ed). USA: John Wiley and Sons.

Mathe
r, J.
,

& Penelope, R. (1998).
Introduction to Cell and Tissue Culture:

Theory
and Techniques
. New York: Plenum Press.

Pezzuto, J.M., Johnson, M.E. & Manasse, H.R. (1993).
Biotechnology and

Pharmacy
. New York: Chapman and Hall.


Proposed
Start Date
(Semes
ter)

Year 200
7
/20
08

Semester
1

Batch of
Students to
be Affected

Year 200
7
/200
8
. (All Batches)





Prepared by:



Checked by:



Approved by:


____
__________________


__________________

_____
______________

(
Dr. Muhammad Taher
) (



) (Prof.
Dr.
Tariq Abdul Razak
)


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Course Assessment Matrix: PHM 2232






Course Learning Outcomes


Programme Outcomes


Outcome 1

Outcome 2

Outcome 3

Outcome 4

Outcome 5

Outcome 6

Outcome 7

Outcome

8

Outcome 9

Outcome 10

Describe t
he biotechnology
-
based therapeutic agents.


1

1

2


2


1




Explain the formulation of biotechnology products.

3

2





2




Discuss the technology in recombinant DNA and its
application in pharmaceutical industry.


3





2


3


Explain the use of tissue culture approach in
pharmaceutical industry.

2

3





1




Describe various methods in producing commercial
products using fermentation biotechnology.


1





3

1



Discuss
t
he theory, clinical, technological , economical
and ethical aspects of the use of biotechnological drugs
such as antibodies and vaccines.

1

1

1


2


1

1

















































*1=objective addresses outcome slightly, 2=moderately, 3=substantive

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The educational outcomes of t
he programme conducted by the Kulliyyah of Pharmacy


At the end of the programme, students should have the ability to:


1.

describe professional ethics for pharmacists and discuss scientific issues from the
Islamic perspective.

2.

integrate knowledge in all asp
ects of drugs beginning with their origin (synthetic or
natural products), medicinal chemistry, pharmacology, compounding or
manufacturing and their usage.

3.

perform the roles of pharmacists in hospital and community settings equipped with
knowledge
related
to pharmacy administration and management, ability to analyze
and solve problems related to pharmacy administration and management.

4.

analyse the common signs and symptoms, laboratory findings and drugs in the
management of common disorders and malignancies
involving all body systems.

5.

integrate the concepts of pharmaceutical care, pharmacotherapeutics and clinical
pharmacokinetics in the identification and resolution of drug related problem.

6.

apply effective communication skills in the delivery of pharmaceutic
al care, perform
patient counselling and monitoring.

7.

perform the roles of pharmacists in compounding or manufacturing of various dosage
forms on both, a small scale and a large scale, that comply with the principles of
GMP, quality control and quality assu
rance.

8.

apply the principles and rationale of drug delivery systems, develop and design drug
delivery systems.

9.

develop practical skills of research in pharmaceutical sciences.

10.

to relate anatomical structure to physiological function and the effects of drugs

on
these functions.