You are on page 1of 3


School of Sciences and Technology

General Manufacturing Biotechnology II
Course Syllabus
I. Description of Course:

A. Purpose: This course covers the basic principles and experiences related to cell culture,
microbial fermentation, production, recovery, packaging.

B. Minimum Grade Required: C

C. Credits: 3 (three)
D. Pre-requisites: BIOT 231
E. Professor: Jacqueline Hernández, MS. (,, Office hours: 939-639-3812)
F. Suggested Text: Basic Biotechnology 2001. C. Rutledge and B. Kristiansen
(Ed.) Cambridge University Press, 2nd edition, ISBN: 051779170.

G.Bibliography: Industrial Biotechnology, A Training Manual, Moorpark College,

2001, Mark Clippinger Ed.) Thomson Learning.

H. Specific Objectives: After completion of the course students will be able to:
1. Describe the different biotechnology equipment and techniques for
fermentation and product recovery.
2. Select the appropriate technique, equipment to be used in a general
manufacturing problema.

I. Duration: One Semester (45 hours)

II. Course Content:
JAN 21 Introduction, Regulatory requirements and
differents kinds of industries
JAN 26-28 Contamination Control in pharmaceuticals
FEB 2 - 4 Aseptic Techniques Aseptic Techniques continuation
FEB 9 – 16 CFR 211 Vol.21 CGMP Subparts B, C and E CGMP Subpart A 211.3
FEB 25-MAR 2 Basic Microbiology CGMP Subpart C & E (1)Case
MAR 9 - 16 Formulation Process Basic Filtration Process
MAR 18-25 Filling Process Environmental Monitoring

School of Sciences and Technology
General Manufacturing Biotechnology II
Course Syllabus

MAR 30-APR6 Sterile Filtration Process Microog. Curve of Growth

APR 8-15 Aseptic Filling Environmental Methods (1)
APR 22-27 Lyophilization Line clearance/cleaning
APR 29-4 Microbial Fermentation Biochemistry and Physiology of
growth and metabolism
MAY 6 Chromatography Spectrophotometry
MAY 11 Recovery-Centrifugation, Recovery Disruption, Packaging Process, Written
MAY 13-up Oral Presentations Written Reports

FINAL TEST – To be announced according to UT-

III. Methodology: The course will be presented in a lectura, discussion format with laboratory
demonstrations that will give the students the best “hands-0n”
1. Basic separation methods: Filtration, Centrifugation, Bioseparation
2. Biochemistry and Physiology of growth and metabolism (fermentation process and
3. Spectrophotometry and Chromatography.

IV. Student Evaluation: The major requirements of this course is the completion of all given
assigments, laboratory exercises. Students will be evaluated using the following:

➢ 3 Exams: each exam 100% (including final test) = total 300%)

➢ Oral and written report: 100%
➢ Laboratory Reports: 100%
➢ Case studies/Assigments: 100%

➢ Final Grade: {400% Conference (75%) + 200% Laboratory (25%)}

The course Grade is recorded as:
A (90 -100%)
B (80 - 89%)
C (70 - 79%)
D (60 - 69%)
F (less tan 60%)

NOTE: The profesor reserves the right to modify the syllabus, assigments, grading procedures, and
other related policies as changes take place during the semester, however, proper notice will be given.

V. Attendance: Mandatory

School of Sciences and Technology
General Manufacturing Biotechnology II
Course Syllabus

VI. Academic Misconduct: Acts of academic misconduct for wich students are subject to
sanctions include witout limitation, plagiarism, cheating, failure or refusal to follow clinical
practice standards, falsifying or manufacturing scientific or educational data and/or representing
manufactured data to be the result of scientific or scholarly experiment or research, and
soliciting, aiding, abetting, concealing, or attemting such an act. Plagiarism is defined as
including, without limitation, the act of representing the work of another as one’s own.
Plagiarism consists of copying, paraphasing, or otherwise using the written, electronic, or oral
work of another without proper acknowledgement or consent of the source or presenting oral,
electronic, or written material prepared by another as one’s own. Plagiarism also includes using
information from electronic resources, including the internet, without the use of proper citations.
In the event of academic misconduct, the student is subject to a number of penalties,
including a failing grade for plagiarized assignment or for a course.