Course Offerings

Downstream processing (DSP) refers to the recovery and purification of a drug substance (DS) from natural sources, such as animal or bacterial cells. Through lecture and hands-on activities, students will learn separation techniques with performing ultracentrifugation, filtration, and chromatography.

Course Objectives

1. Demonstrate proficiency with Ultracentrifugation, Tangential Flow Filtration, and Anion Exchange Chromatography.
2. Develop an understanding of Viral Filtration, Column Packing, SPTFF, HETP, and Asymmetry.
3. Gain hands-on experience performing filtration steps to purify the target product (protein).
4. Gain hands-on experience identifying components of a small-scale chromatography system and performing Anion Exchange Chromatography separation.

Outline of Instruction

Day 1: Protein & Process Consideration, Process Operations
a. Lecture: Proteins & Process Considerations
i. Process flow & phases
ii. Proteins
1. Principles
a. Chemistry & Functions
b. Types of Proteins
2. Green Fluorescent Protein (GFP)
iii. Process Considerations
1. Impurities
2. Aseptic Technique
b. Lecture: Process Operations
i. Harvesting
ii. Cell Disruption
c. Lab: Ultracentrifugation
d. Lecture: Process Operations
i. Solid-liquid separation
e. Lab: Filter Integrity Test / Bubble Point Demonstration
f. Lab: Tangential Flow Filtration
g. Lecture: Purification
h. Lecture: Performance, Trouble Shooting, Maintenance
i. Lecture: Filling of Bulk Drug Substance
j. Lecture: Yield
k. Review, Q&A
Day 2: Anion Exchange Chromatography
l. Lab: Anion Exchange Chromatography
m. Lecture: Evaluations & Certificates

Contact Hours

16

CEUs

No

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

None

Learning Supplies Needed

text provided by college, lab supplies and equipment supplied by college

Clinical Site/Special Facilities

NC BioNetwork Capstone Center, or downstream cleanroom facility, or facility equipped with downstream operations equipment

Requirements for Successful Completion

90% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

• Bioprocess Technicians, Bioprocess Engineers, Manufacturing Associates, Fermentation Technicians, Purification Technicians, Purification Lab Analysts, Chromatography Associates.

Specific Industry or Business Support Needs

Bioprocess Engineer, Bioprocess Technician, Gene Therapy Operation Specialist, Manufacturing Associates, Purification Technician, Purification Lab Analyst

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Bioprocess Engineer

Bioprocess Technician

Gene Therapy Operation Specialist

Manufacturing Associates

Purification Technician

Purification Lab Analyst

Related Courses

SEF-412CL

BTC-3300G6

CTP-3001PD1

CTP-JI01

Course Contact Information

[email protected]