BIO 499
Pharmaceutical Laboratory Practices
Spring, 2007

California State Polytechnic University, Pomona
Instructor:
Dr. Wei-Jen Lin
bldg 4, Rm 3-760 (Office)
909-869-4179 (tel); weijenlin@csupomona.edu
http://www.csupomona.edu/~weijenlin; click on Bio499
Lecture:
T Th 4-4:50 pm, Rm 4-2-529
Lab:
T Th1-3:50 pm, Rm 4-2-529
Office Hours: 
T Th 10:20 am - 12 pm; W 1 - 2:40 pm; Additional hours by appointment

Web resource:
FDA - Food and Drug Administration
FDA Compliance Program - Guidance Manual for FDA inspection

eCFR
- Search and retrieve Code of Federal Regulations
CFR title 21 - CFR related to Food and Drug Administration
Clinical Trial Search
BIO - Biotechnology Industry Organization
PhRMA - Organization for leading research-based pharmaceutical and biotechnology companies
Biotechnology glossary
Career in Biotechnology/Pharmaceutical companies - job descriptions, salary ranges, etc.
SOP instruction
US Biotechnology Report 2003 - by Department of Commerce

Selected Company profiles
Center for Biomedicine and Genetics, COH
Med-Pharmex Inc.
Watson Pharmaceuticals
Allergan Inc.
Gilead Sciences

Method Compendia and Standards
US Pharmacopeia
AOAC
BAM
NCCLS
ISO

Course description:
This is a laboratory-based course that provides students with the opportunity to learn laboratory skills commonly used in the biotech/pharmaceutical industry. These skills include data recording, project management, and the use of the US Pharmacopeia protocols for microbial and chemical testing of pharmaceuticals. Regulations and documentation requirements along with good laboratory practices and good manufacturing practices will be incorporated.

Prerequisites:
MIC201 and CHM221; or with the consent from the instructor

Textbook and reading
There is no textbook that covers these topics. The instructor will provide handouts for lectures. Lab manual is available at the CopyNmail center.

Who would benefit from the course:
For those who 1) would like to work in the industry, 2) will oversee laboratory operation (e.g. FDA investigator, project manager); or 3) would like to work on projects to enhance laboratory and critical thinking skills.

Class Requirements
Attendance is assumed. Students are responsible for lecture and laboratory materials missed in their absence. Missed laboratories cannot be made up. Missed exams may be made up only if the instructor has been informed of the absence and found the excuse acceptable before the exam. Students are expected to participate in field trips during or beyond the class hours.

Examination and Grade Determination (tentative)
Bi-weekly quizzes and one final exam are scheduled. Exams will be multiple choices and short answers. Team project will be described later. The lecture and lab will be graded together.

 
Points
% of total points
Grade
Quizzes
100
90-100%
A
Final exam
100
80-90%
B
Lab notebook/assignments
100
65-80%
C
Team project/report
200
50-64%
D
Total points
500
 

Tentative Course and Lab Outline

Dr. Lin Home
Office Hour
Biotech Internship
Biology Home
Cal Poly Home