This course has earned the Affordable UF badge by selecting required materials that cost less than $20 per credit hour.
To access the syllabus, visit Simple Syllabus and search by term and course.
Note: For Fall 2026 registration, please use PHA6935 to enroll in Selected Topics in Pharmacy: Biological Drug Development in the Pharmaceutical Industry. Starting Spring 2027, the permanent course number will be PHA6173.
Credits
This course is 3 credits.
Description
This course provides the basis for a deeper understanding of the development of biological drug products (e.g., cell and gene therapies) from pre-clinical development through IND submission in the pharma & biotech industries as well as an overview of the QA/QC regulatory considerations that are needed for successful FDA filing.
Topics
| Module | Topic |
|---|---|
| Module 1 | A Brief History of the Pharma and Biotech Industry |
| Module 2 | Overview of Common Regulatory Standards |
| Module 3 | Introduction to Quality Practices and SOPs |
| Module 4 | Overview of Pharmaceutical Bioprocessing |
| Module 5 | Product Scaling: Bench to Bioreactor |
| Module 6 | Development of Biological Agents and Cell Therapy Products |
| Module 7 | Development of Biological Agents and Cell and Gene Therapy Products |
| Module 8 | Introduction to Quality Assurance and ISO 9000 |
| Module 9 | Introduction to Quality Control and QC Testing |
| Module 10 | Safety Testing for Biological Agents, Cell and Gene Therapies |
If you have additional questions about the content of this course, please contact Clinical Professor & Director, Dr. Oliver Grundmann (grundman@ufl.edu).
Note to Non-UF Students:
Students new to the University of Florida system who wish to take this course as an elective for other institutions, for continuing education outside of a degree-seeking program, or do not otherwise wish to apply to a University of Florida program at this time need to fill out a Non-Degree Application during the enrollment process. Access the Critical Dates calendar for important deadlines.
Transfer of Credit
Transcripts are not automatically sent to the student after each term and must be requested by the student after completion of the course.
To gain access to your unofficial transcript online, go to One.UF at UF. You will need your Gatorlink ID username and password. Once in the system, click on “records” and “unofficial transcripts.” If you have graduated or not taken courses for more than one term, you will not have access to the unofficial electronic transcript.
For official transcripts, follow the Transcript Request Procedures to request transcripts from the Registrar. Grade transcripts can be requested only after the grades are released through One.UF. If you have a valid Gatorlink username and password you can login to One.UF and verify if the grades have been posted to the transcript before ordering.
Required Materials
No textbooks are required for this class. Helpful textbooks include:
Biologics and Biosimilars: Drug Discovery and Clinical Applications
Editors: Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang
Publisher: CRC Press; 1st edition (6/14/2022)
ISBN: 978-1138594227
Available through the UF Health Science Center (HSC) Library
Library Access
UF online graduate students enjoy the same library privileges as on-campus students. Visit the University of Florida Libraries to find books, journals and more.