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UNIVERSIDAD DEL TURABO 2009

School of Sciences and Technology

General Manufacturing Biotechnology I - BIOT 231


Course Syllabus

I. Description of Course:

A. PURPOSE: This course covers the basic principles and experiences related to cell cultura,
sterilization, media preparation and recovery process. General Manufacturing Biotechnology I is
a one semestre course designed to give students an introduction to the scientific concepts
currently used in the field of biotechnology. Students will develop skills, critical thinking, and
communication skills currently used in the biotechnology industry. Through extensive Reading
laboratory Project work and simulation of workplace experience students will evaluate career
opportunity in th efield of Biotechnology. The course will have as its foundation the
implementation of Good Manufacturing Practices which governs all facets of production in the
biotechnology industry.

B. Minimum Grade: Required: C

D. Credits: 3 (Three)

E. Professor: Jacqueline Hernandez, MS. (ninotchkahernandez@gmail.com,


ehernandez105@email.suagm.edu, Office hours: 939-639-3812)

F. Pre-requisites: CHEM 100 or BIOL 100

G. Specific requisites: None

H. Co-requirements: None

I. Suggested Text: Basic Biotechnology 2001. C. Rutledge and B. Kristiansen (Ed.) Cambridge
University Press, 2nd edition, ISBN: 051779170.

J. Bibliography: Industrial Biotechnology, A Training Manual, Moorpark College, 2001, Mark


Clippinger Ed.) Thomson Learning.

K. Specific Objective: After completion of the course, students will be able to:
1. Describe the different techniques for cell culture and product recovery.

II. Course Content:

Date Topics
Jan 22 Introduction, Types of Pharmaceuticals Industry
Jan 27,29, CFR 21 Vol. 4 Parts 210, 211 and 11 CFR CGMP
Part 210 Sec. 210.1-3. Part 211 Subpart A General Disposition and subpart B
Organization and Personnel
Feb 3 Subpart C Edificios y Facilidades
Feb 5 Subpart s D Equipment and Subparts Control de componentes, envases y cierres
para productos farmaceuticos
Feb 10 Subparte F Controles de Produccion y de Procesamiento and Regulatory
UNIVERSIDAD DEL TURABO 2009
School of Sciences and Technology

General Manufacturing Biotechnology I - BIOT 231


Course Syllabus

Requirements (OSHA, EPA)


Feb 12 Biotechnology , Past and Present,
Feb 17 Exam
Feb 19 Overview of Cell Culture, The characteristics of model Organisms used in
Biotechnology
Feb 24 Standard Operating Procedure(SOP) , Media preparations,
Feb 26 Sterility, Contamination, Quality Control Testing
Mar 3, 5,10 Small Scale Cell Culture
Mar 12, 17 & 19 Large Scale Media Preparation
Mar 24 EXAM
Mar 26, 31 Evaluation of Cultures
Apr 2, 7,14 Cell Morphology
Apr 16, 21 Confluences
Apr 23 & 28 Oral Reports
Apr 30 Bioinformatics, Data handling with computers
May 12 – 14 Review
Final Exam Schedule according UT

III. Duration: One Semester (45 hours)

IV. Methodology: The course will be presented in a lecture, discusssion, case studies and
laboratory demonstrations that will give the students the best “hands-on”
A. Laboratory Demonstrations:
1. Introduction to biotechnology workplace: GMP, OSHA, EPA regulations for
industry
2. QA/QC- Quality Assurance/Quality Control: Preclinical and Clinical Testing,
and regulatory process.
3. Laboratory Measurements: Instrumental methods, weight, volumen,
temperatura, pH and conductivity measurements.
4. Cell cultura handling and preparation.
5. Data handling: Description of data, collection data.
6. Bioinformatics and data handling with computers.

V. Students Evaluation: The major requirements of this course is the completion of all given
tasks, laboratory exercises, exams, etc. Students will be evaluated using the following:

The course gade is recorded as:


A (90 -100%)
B (80 - 89%)
C (70 - 79%)
D (60 - 69%)
F (less tan 60%)

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


b. Oral and written report: 100%
UNIVERSIDAD DEL TURABO 2009
School of Sciences and Technology

General Manufacturing Biotechnology I - BIOT 231


Course Syllabus

c. Laboratory Reports: 100%


d. Case studies/Assigments: 100%
e. Final Grade: 400% Conference (75%) + 200% Laboratory (25%)

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

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.