PRINCIPLES OF THE BIOSCIENCE INDUSTRY
COURSE NUMBER: TBD
TWO CREDIT HOURS
SEMESTER/YEAR: TBD
UF CAMPUS, UF CERHB BIOTILITY (ALACHUA)
CLASS MEETING TIME(S): CLASS WILL MEET ONE DAY/WEEK (PERIODS 9-11, 4:05-7:05)
INSTRUCTOR: Dr. Richard Snyder
ARB RG-291, rsnyder@cerhb.ufl.edu, 386-418-1642
OFFICE HOURS: Wednesday & Friday, by appointment
COURSE TA OR COORDINATOR: Tammy Mandell (tmandell@cerhb.ufl.edu), Lori
Wojciechowski (lwojo@ufl.edu), UF CERHB Biotility 386-418-8199
**COURSE WEBSITE: TBD
** COURSE COMMUNICATIONS: email, phone
REQUIRED TEXT: Yali Friedman, Building Biotechnology: Business, Regulations, Patents,
Law, Policy, Politics, Science, Logos Press; 4th Edition (2014) ISBN-13: 978-1934899298.
In addition, students will be required to purchase a course pack, which includes lecture
materials, industry documentation to be used in class, and laboratory activities.
MATERIALS AND SUPPLIES FEE: $40
ADDITIONAL RESOURCES: FDA Website- http://www.fda.gov
Lab coats, non-latex gloves and safety glasses are available in class.
COURSE DESCRIPTION:
An introduction to the practices, skills and careers in the biotechnology industry
providing an applied understanding of regulatory compliance, product development,
process development, manufacture, testing, and release-for-sale of biomedical
products. Through lecture and hands-on laboratory applications, students learn the
profiles of major departments, and participate in simulated departmental roles.
PREREQUISITE KNOWLEDGE AND SKILLS: Biology and Chemistry: BSC 2011, BSC 2011L,
CHM 2046 and CHM 2046L.
PURPOSE OF COURSE:
Created in response to industry demand for employees with pre-existing knowledge and
experience working in a regulated (cGMP compliant) environment, this course provides
students the opportunity to learn and apply critical elements associated with the
development, production, testing, and commercialization of biomedical products in the
marketplace. In addition, this course will assist students make the transition from
performing academic research, to applying science concepts and skills to careers in the
biotechnology industry, including pharmaceutical, biopharmaceutical, diagnostic, or
medical device.
COURSE GOALS:
Upon completion of this course you will have an understanding of the methods and
strategies involved in biomedical product discovery, development, manufacturing, and
testing processes, including the quality systems required for regulatory compliance. You
will gain practical experience in applying current Good Manufacturing Practices to the
manufacture and testing of biomedical products by participating in production, quality
control, and quality assurance activities.
AND/OR OBJECTIVES: By the end of this course, students will:
1. Describe the major steps from discovery of a biomedical product to
commercialization for human use.
2. Understand regulations, regulatory compliance and current Good Manufacturing
Practices and how they are applied to key areas of a regulated industry.
3. Describe the major industry departments, associated careers, and their primary
role in ensuring the release of a regulatory compliant product.
4. Explain general strategies used in biomanufacturing to ensure that vaccines,
antibodies and biopharmaceuticals are pure, efficacious, and safe.
5. Understand the principles that underlie operations used in upstream
(fermentation, cell culture) and downstream processing of biopharmaceuticals
(e.g., homogenization, centrifugation, filtration, chromatography, and
ultrafiltration).
6. Describe the chemical and physical properties of biomacromolecules and how
those properties influence the design of assays.
7. Name critical parameters monitored during upstream and downstream
bioprocessing and how they demonstrate process control.
8. Write and execute standard operation procedures (SOPs), batch records and test
records for biomanufacturing and testing.
9. Analyze common bioprocessing failures to determine root cause and
recommend corrective actions;
10. Describe the stages and purpose of both process validation and assay validation
11. Explain the major drivers of Biotechnology business development
TEACHING PHILOSOPHY: Through active participation in this course, you will quickly
practice concepts and skills that will expand your understanding of the drug discovery –
to – product continuum, and that will assist in your preparation for a variety of
bioscience-related careers.
INSTRUCTIONAL METHODS: Topics are presented in blended lecture/hands-on format,
making efficient use of laboratory time by delivering relevant lecture topics during
biomanufacturing and quality testing laboratory exercises. The course includes a variety
of learning activities, including: small group discussions, individual written assignments,
and participation in simulated industry jobs. A collection of learning media (classroom
lecture, company simulations, internet-based, case studies) will be utilized.
Reading assignments will include documents from regulatory agencies, and published
case studies to explore quality compliance issues related to regulations published by the
United States Food and Drug Administration (FDA) and other international Regulatory
Agencies.
COURSE POLICIES:
ATTENDANCE POLICY: Because this course is designed to simulate workplace
experiences in the biotechnology industry, attendance and active participation are
mandatory. Students will drop one full grade for each unexcused absence. Up to 2
absences are allowed for a passing grade. Requirements for class attendance and make-up
exams, assignments, and other work in this course are consistent with university policies that
can be found at: https://catalog.ufl.edu/ugrad/current/regulations/info/attendance.aspx.
**QUIZ/EXAM POLICY: A mid-term and a cumulative final exam are scheduled. See
section on class policies and procedure regarding questions about exam scores and
requests for makeup exams.
MAKE-UP POLICY: students are allowed to make up exams that are missed due to
religious holidays, and for unavoidable, excused absences.
**ASSIGNMENT POLICY: Weekly activities, an audit exercise, a midterm, and a final
exam assess the student’s knowledge of the subject matter.
**COURSE TECHNOLOGY: Instrumentation used in class will include cleanroom
simulator, a shaking incubator for cell growth, biosafety cabinet, spectrophotometer, pH
meter, high speed and high capacity centrifuges, electrophoresis equipment, gel
imaging system, micro and macro pipetting systems, and basic lab ware. All equipment
will be available only during designated class periods.
COURSE EVALUATIONS: Students are expected to provide feedback on the quality of
instruction in this course by completing online evaluations at https://evaluations.ufl.edu.
Evaluations are typically open during the last two or three weeks of the semester, but students
will be given specific times when they are open. Summary results of these assessments are
available to students at https://evaluations.ufl.edu/results/
UF POLICIES:
UNIVERSITY POLICY ON ACCOMMODATING STUDENTS WITH DISABILITIES: Students
requesting accommodation for disabilities must first register with the Dean of Students
Office (http://www.dso.ufl.edu/drc/). The Dean of Students Office will provide
documentation to the student who must then provide this documentation to the
instructor when requesting accommodation. You must submit this documentation prior
to submitting assignments or taking the quizzes or exams. Accommodations are not
retroactive, therefore, students should contact the office as soon as possible in the term
for which they are seeking accommodations.
UNIVERSITY POLICY ON ACADEMIC MISCONDUCT: Academic honesty and integrity are
fundamental values of the University community. Students should be sure that they
understand the UF Student Honor Code at http://www.dso.ufl.edu/students.php.
**NETIQUETTE: COMMUNICATION COURTESY: All members of the class are expected
to follow rules of common courtesy in all email messages, threaded discussions and
chats. [Describe what is expected and what will occur as a result of improper behavior]
http://teach.ufl.edu/docs/NetiquetteGuideforOnlineCourses.pdf
GETTING HELP:
For issues with technical difficulties for E-learning in Sakai, please contact the UF Help
Desk at:
● Learning-support@ufl.edu
● (352) 392-HELP - select option 2
● https://lss.at.ufl.edu/help.shtml
** Any requests for make-ups due to technical issues MUST be accompanied by the
ticket number received from LSS when the problem was reported to them. The ticket
number will document the time and date of the problem. You MUST e-mail your
instructor within 24 hours of the technical difficulty if you wish to request a make-up.
Other resources are available at http://www.distance.ufl.edu/getting-help for:

Counseling and Wellness resources

Disability resources

Resources for handling student concerns and complaints

Library Help Desk support
Should you have any complaints with your experience in this course please visit
http://www.distance.ufl.edu/student-complaints to submit a complaint.
GRADING POLICIES:




35% - Participation & Attendance: Students will drop one full grade for each
unexcused absence. Up to 2 absences are allowed for a passing grade.
Participation includes:
o Active discussion on assigned readings 15%.
o Completion of laboratory activities associated with biomanufacturing and
testing 10%.
o Completion of documentation associated with biomanufacturing and
testing activities 10%.
15% - Written Essay (5 pages [not including cited references], double-spaced,
topic choice will be approved), and 5 min. Report
25% Mid-Term
25% - Final Exam (25 Multiple Choice for 75 pts., one Essay Question for 25 pts.)
GRADING SCALE:
Passing Grade A
Grade Points 4.0
A3.67
B+
3.33
B
3.0
B2.67
C+
2.33
C
2.0
C1.67
D+
1.33
D
1.0
D0.67
E
0
S/U
0
For more detailed information about grades and grading policies please see:
http://www.isis.ufl.edu/minusgrades.html
http://gradschool.ufl.edu/catalog/current-catalog/catalog-general-regulations.html#grades
COURSE SCHEDULE:
Assigned Reading Discussion Held each class period in addition to scheduled activity
Week
1
Date
8/27
Lecture/Lab Topic
Reading
Drug Development
Overview
P. 3-12 Development of
Biotech
Regulations, Regulatory
compliance, Current Good
Manufacturing Practices
P. 19-27 Molecular Biology
Assignment/Activity
Lab Safety Procedures
Equipment Overview
P. 29-40 Drug Development
Industry Documentation
2
9-3
Departmental Roles &
Organization
P. 119-150 Regulations
P. 327-331 Career
Development
Company Model: Making
cGMP compliant Popcorn
Departmental Role Handouts
3
9/10
Product (Plasmid)
Overview
Raw Materials
Document Training
P. 209-226 Research &
Development
Student “companies” formed
(Manufacturing & QA/QC)
QA Issue of Docs to QC and
Manuf.
Innoculate media to start
batch
4
5
9/17
9/24
In-Process Monitoring &
Control
Manuf.- Read Production Batch
Record (PBR)
Manuf: Harvest cells per
Batch Record
Product Purification
Methods
QC - Read Test Record (TR) for
A600
QC: Test Record for A600
(Cell growth)
Final Formulation & Fill
Finish
P. 89-118 Patents & IP
Manuf: Lyse Cells,
Purification
Assay Validation
QC TR for pH
P. 161-182 Company Formation
Manuf. PBR
6
10/1
Choose FDA paper topic
P. 151-160 Policy
QC: Testing of Final Product
P. 183-207 Finance
QA: Document review
(product release)
Manuf. PBR
7
10/8
Testing for Endotoxin
QC: Test Record for pH of
Raw Material
QC TR for A260/280, TR for
Endotoxin, TR for Gel
Electrophoresis (purity and
identity)
Manuf: FDA Warning Letters
Mid Term
Mid Term
Read Test Record for balance
calibration
Calibration of balance using
NIST weights
Navigating FDA Website
8
10/15
Deviations, Planned
Variance, and Corrective &
Preventative Action
Switch roles
Calibration & Preventive
Maintenance
Document Training, QA Issue
of Docs to QC and Manuf.
Innoc. media to start batch
9
10/22
Project Management
P. 227-250 Marketing
Manuf. Read Production Batch
Record (PBR)
10
10/29
Manuf: Harvest cells per
Batch Record
QC Read Test Record (TR) A600
QC: Test Record for A600
(Cell growth)
Building Systems & Facility
Design
P. 251-270 Licensing, Alliances,
& Mergers
Manuf: Lyse Cells, Product
Purification
Equipment Qualification
and Validation
Manuf. PBR
QC TR for pH
QC: Test Record for pH of
Raw Material
P. 271-286 Managing Biotech
QC: Testing of Final Product
Manuf. PBR
QA: Document review
(product release)
Product Changeover
12
11/5
Presentations of 5000 level
(Investigation of a product
recall)
QC TR for A260/280, TR for
Endotoxin, TR for Gel
Electrophoresis (purity and
identity)
Manuf: FDA Warning Letters
13
11/12
Medical Devices
Product Labeling &
Shipping
14
11/19
15
12/3
16
12/17
P. 287-300 International
Biotech
FDA Paper Due
5 min. Presentations
Cleanrooms & Gowning
5 min. Presentations Cont.
Environmental Monitoring
Gown, enter cleanroom,
perform particle count, and
aseptic product vialing.
Review
Tour of RTI-Surgical and Sid
Martin Biotech. Incubator
Final Exam