Pharmaceutical Sciences Course Syllabus - Campbell - Campbell ...

sweatertableΒιοτεχνολογία

3 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

176 εμφανίσεις

Pharmaceutical Sciences Course Syllabus

Campbell University School of Pharmacy

Spring 2007


Course Title


Bioprocessing I

Course Number

PHSC 5
38

Credit Hours


4

Required/Elective

Required for MSPS Biotechnolog
y track

Prerequisites


Biochemistry with lab

an
d molecular biology with lab

or instructor’s

permission

Description

This bioprocessing course provides an introduction to the theory and
application of biotechnology procedures
related
to the development of
biopharmaceutical products. Students are provid
ed with an overview of

prokaryotic and eukaryotic metabolic and
genetic regulation
,

cell culture
principles, bioprocess design and validation, and pharmaceutical product
generation. Prerequisites include successful completion of courses in
biochemistry an
d molecular biology (or demonstration of
experience).
The course will combine lectures with hands
-
on laboratory
exercises.


Course Director

Tim Bloom, Ph.D.

Office



Room 104A Hall of Science 893
-
1712



Email



bloom@campbell.edu

Web Page


www
.campbell.edu/
faculty/
bloom

Lab



Room 104 Hall of Science


Office Hours


Open Door Policy (also by appointment)


Justification

The use of
cultured cells and microorganisms to produce pharmaceutical
agents

has

long be
en a cornerstone of the pharmaceutical industry,
allowing for economical production of antibiotics and vaccines
. The
ability to use cloned genes to allow expression and purification of
protein products at an industrial scale has become a major source of ne
w
pharmaceuticals. Given the complex
nature of the cells used for
biopharmaceutical production, it is important to understand the variables
that must be controlled in the industrial growth of cells.

This course
covers theory and basic application concernin
g the growth of cells from
bench top to industrial production levels

for a variety of product classes
.
This course promotes the mission of Campbell University by equipping
students with superior skills in cell culture and fermentation, which will
allow the
m to work productively in the bio
-
pharmaceutical industry and
improve the health of American consumers.

Textbook
s

Bioprocess Engineering: Basic Concepts

(2
nd

edition)
by
Schuler and
Kargi, Prentice Hall (2002).

Industrial Microbiology: An Introduction

by

Waites, Morgan, Rockey
and Higton, Blackwell Science (2001)

Cell Culture Technology for Pharamceutical and Cell
-
based Therapies
,
Ozturk and Hu, editors, Taylor and Francis (2006)

These are resources used by the instructor and are not required purchases

fo
r the students.
R
eading assignments will be
provided

from available
reference or textbooks, the primary literature and review articles as
deemed appropriate by the instructor.


Grades



Grades will be based on the following components:




Three in
-
class

ex
ams



100

points each




Final cumulative exam



100 points




Lab reports




2
00 points




Total points possible

6
00

In
-
class exams are scheduled for t
he weeks of 2/
12
, 3/
19
, and 4/2
3
,
and will cover all material since the previous exam.


Points earned wi
ll be calculated as percent of total possible points and a
grade assigned from the percentage. The following 10
-
point scale will be
used for grades, with rounding provided by Microsoft Excel:




90
-
100%


A




80
-
89%



B




70
-
79%



C




60
-
69%



D




Below

60%


F




Grading on the curve is
never

done in this class.


Objectives


After successfully completing this course, the student
will

be able to:

1.

Describe the basic features of cells commonly used in the
biotechnology industry.

2.

Outline the basic metabolic

pathways in mammalian and bacterial
cells, and the components in culture media that meet the needs of
these pathways.

3.

Describe the dysregulation seen in the metabolism in cultured
mammalian
cells and how this dysregulation impacts cell growth and
producti
vity.

4.

Outline the role of post
-
translational modifications (and the ability
of the host cell to perform them) on the activity of therapeutically
relevant proteins.

5.

Describe the factors that
control

the medium composition for both
cell culture and fermentat
ion.

6.

Describe strategies for medium development.

7.

Describe the growth kinetics of cells in culture, and the balance
between growth and product formation.

8.

Explain the operating principles of commonly used fermentors and
bioreactors.

9.

Explain the basic paramet
ers controlled by fermentors and
bioreactors
(e.g. aeration, agitation, heat transfer)
for maintenance
and expansion of
cells.

10.

Explain
aspects of objective #
9

relating to scale
-
up of culture
volumes.

11.

Describe strategies for dealing with issues related to s
cale
-
up.

Policies

-

The Campbell University policy on attendance will be followed, as will the
Honor Code concerning cheating.
All students are subject to the academic
integrity and behavioral expectations of the University.


-

No exams will be made up wit
hout the
prior

permission of the instructor.
Medical excuses MUST be discussed with the instructor as soon as possible after
missing an exam, and a doctor’s note will be required for a makeup exam.


-

Questions about exam grades must be
submitted in writin
g to

the instructor
within one week of the exam’s return to the student.


-

The course syllabus and lecture schedule will be posted on the web page
indicated above. Schedule changes will be posted there as well as announced in
class.


-

Handouts used as r
eading material will be available prior to the lecture during
which they will be discussed.
Reading assigned material prior to class is advised.


-

Students with documented disabilities who desire modifications or
accommodations should contact the office o
f Student Support Services located in
the University’s Hight House.


Tentative Topic Schedule
:



Recombinant DNA technology and cell line development



Industrial microorganisms



How cells grow

o

Microbial cell structure and function

o

Microbial growth and nutritio
n

o

Microbial metabolism

o

Mammalian

cell metabolism

o

P
ost
-
translational modifications



Fermentation systems

o

Fermentation media

o

Medium development

o

Stoichiometry of microbial growth and product formation



B
ioreactors

o

Operating considerations for bioreactors for s
uspension and
immobilized cultures

o

Aeration, mixing and hydrodynamics in bioreactors

o

Fed
-
batch cultivation of mammalian cells for the production of
recombinant proteins

o

Optimization of high cell density perfusion bioreactors

o

Selection, scale
-
up, operation
and control of bioreactors



Bioprocess considerations in using animal cell cultures



Using genetically engineered organisms

to address production limitations



Cell cultu
re kinetics and modeling



As appropriate through the semester, examples of products and pro
cesses
currently in use will be discussed to illustrate concepts discussed in class