Course Offerings

This course will focus on the details of the typical processing procedures utilized to produce a biopharmaceutical - a pharmaceutical produced by biotechnology. An understanding of the science and the equipment commonly used in each process step will be presented along with a review of the basic biochemistry involved in biotechnology and current pharmaceutical applications. Hands-on laboratory exercises will provide experience in the fermentation, product isolation, and purification of a protein.

Course Objectives

Become familiar with the fundamental science behind biotechnology and its application in the pharmaceutical industry

Learn the basic science, equipment, and processing steps typically utilized in the production, isolation and purification of a biopharmaceutical product

Gain hands-on experience and familiarity with common instrumentation used in the production, isolation and purification of a protein

Outline of Instruction

Lecture
a. Central dogma (gene to codon)
b. Cells and cell types
c. Products
d. Lab experiment overview
e. The pharmaceutical environment
f. Basic cGMP principles
g. Recombinant DNA techniques
h. Arabinose operon

Labs
a. Shaker flask operation
b. Bioreactor component identification
c. Arabinose usage as an inducer

Lecture
a. Brief history of fermentation, metabolism and growth
b. Expression systems for protein production
c. Fermentation equipment, control, monitoring
d. Fermentation design and sterility
e. Fermentation production flow

Labs
a. Growth run using fermentor
b. Cell pellet sonication and centrifugation
c. Tour of upstream facilities

Lecture
a. Amino acid chemistry
b. Nature of proteins
c. Downstream processing
d. Cell disruption
e. Solid-liquid separations (centrifugation, filtration)

Labs
a. Chromatography sample preparation
b. Identify components in chromatography system

Lecture
a. Product concentration and purification operations (ultrafiltration, evaporation, precipitation, liquid extraction, crystallization)
b. Chromatography (size exclusion, affinity, ionic exchange, hydrophobic interaction)
c. Dialysis/diafiltration

Labs
a. Chromatography operations
b. Tour of downstream facilities

Lecture
a. Protein refolding techniques
b. Final concentration, formulation, filtration, drying, final packaging

Review and assessment

Contact Hours

32

CEUs

1

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

Incumbent worker in the industry, entry level process technician, successfully completion of BioWork course, or equivalent.

Learning Supplies Needed

None

Clinical Site/Special Facilities

None

Requirements for Successful Completion

90% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Specific Industry or Business Support Needs

N/A

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Related Courses

Course Contact Information

BioNetwork Manager

[email protected]