Course Offerings

This course is designed for teaching faculty biomanufacturing operations. It provides an overview of good manufacturing practices and describes the elements of a well-designed pharmaceutical facility. Theory and practice are covered for upstream, downstream and finishing operations, providing an overview of processing from start to finish. Adult-learning best practices and teaching points are presented throughout the course.

Course Objectives

Explain the uniqueness of our industry and culture in terms entering students can understand

Define good cleanroom habits and how to properly gown

Explain types of contamination, where each comes from and how it is controlled in the process

Explain basic protein chemistry, denaturation and why A280 is used for identifying total protein

Identify basic manufacturing flow for biomanufacturing process

Identify key manufacturing equipment, utility systems, valving and sanitary fittings

Identify key process sensors and explain what a DCS system does

Define purpose of the upstream process, identify what each operation does and how it works

Define purpose of the downstream process, identify what each operation does and how it works

Explain the importance of formulation, final packaging and labeling

Outline of Instruction

Biotechnology and Protein Chemistry
a. Basics of biotechnology
b. Uniqueness of industry
c. Chemistry of proteins

The Place We Work
a. Controlling contaminants
b. Key manufacturing equipment, valves and fittings
c. Key utilities
d. Automation

Upstream Manufacturing
a. Nutrient requirement and growth
b. Rules for sterility
c. Fermenter design
d. Instrumentation and control
e. Support systems
f. Fermentation operations

Downstream Manufacturing - Part 1
a. Cell disruption
b. Solid/liquid separation
c. Ultrafiltration

Downstream Manufacturing - Part 2
a. Chromatography

Formulation and Finishing Operations
a. Final concentration
b. Formulation
c. Sterile filtration
d. Freeze drying: Lyophilization
e. Packaging and labeling

Contact Hours

8

CEUs

No

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Learning Supplies Needed

Provided by the college

Clinical Site/Special Facilities

Classroom or virtual technology

Requirements for Successful Completion

80% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Bioprocess technicians, students in biotechnology degree programs, those working the in pharma industry, community college faculty

Specific Industry or Business Support Needs

Students or individuals working in the Biopharma Industry.

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Bioprocess technicians

Manufacturing operator

Gene therapy operation specialist

Related Courses

BTC-3600B4

BTC-3200A7

CTP-YH1

CTP-ZJ1

CTP-FR01

CTP-JI01

Course Contact Information

[email protected]