Mfg Ii Syllabus

UNIVERSIDAD DEL TURABO 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. ([email protected], [email protected], 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: DATE

TOPICS

DIGITAL CONFERENCE

JAN 21

Introduction, Regulatory requirements and differents kinds of industries

JAN 26-28

Contamination Control in pharmaceuticals environments

FEB 2 - 4

Aseptic Techniques

Aseptic Techniques continuation

FEB 9 – 16

CFR 211 Vol.21 CGMP Subparts B, C and E

FEB 23

EXAM

CGMP Subpart A 211.3 Definitions

FEB 25-MAR 2

Basic Microbiology

CGMP Subpart C & E (1)Case studies

MAR 9 - 16

Formulation Process

Basic Filtration Process

MAR 18-25

Filling Process

Environmental Monitoring 1

UNIVERSIDAD DEL TURABO 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 20

EXAM

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 Reports

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 biosíntesis). 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 2

UNIVERSIDAD DEL TURABO 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.

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