Mfg I Syllabus

UNIVERSIDAD DEL TURABO School of Sciences and Technology

2009

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. ([email protected], [email protected], 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 Jan 22 Jan 27,29,

Feb 3 Feb 5 Feb 10

Topics Introduction, Types of Pharmaceuticals Industry 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 Subpart C Edificios y Facilidades Subpart s D Equipment and Subparts Control de componentes, envases y cierres para productos farmaceuticos Subparte F Controles de Produccion y de Procesamiento and Regulatory

UNIVERSIDAD DEL TURABO School of Sciences and Technology

2009

General Manufacturing Biotechnology I - BIOT 231 Course Syllabus

Feb 12 Feb 17 Feb 19 Feb 24 Feb 26 Mar 3, 5,10 Mar 12, 17 & 19 Mar 24 Mar 26, 31 Apr 2, 7,14 Apr 16, 21 Apr 23 & 28 Apr 30 May 12 – 14 Final Exam

Requirements (OSHA, EPA) Biotechnology , Past and Present, Exam Overview of Cell Culture, The characteristics of model Organisms used in Biotechnology Standard Operating Procedure(SOP) , Media preparations, Sterility, Contamination, Quality Control Testing Small Scale Cell Culture Large Scale Media Preparation EXAM Evaluation of Cultures Cell Morphology Confluences Oral Reports Bioinformatics, Data handling with computers Review 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 School of Sciences and Technology

2009

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.