Content

Hands-On Biomanufacturing of Vectors for Gene Therapy

• July 28–31, 2026 — REGISTER

Delivery methods

	35% Lecture
	10% Discussion/group activity
	55% Hands-on lab experience

Course content

	20% Fundamentals and concepts
	70% Industry applications
	10% Emerging technologies

Upstream

Downstream

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you attend?

To obtain hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in both HEK293 cells and Sf9/Baculovirus systems. Engage in pilot/manufacturing-scale upstream operations (adherent and suspension cell culture, vector production scale-up in cell stacks and single-use bioreactors); downstream operations (cell lysis, product recovery via depth filtration, purification using chromatography, and ultrafiltration for concentration and buffer exchange); and analytical technologies, as well as discuss strategies and issues around scale-up, tech transfer, and adherent vs. suspension cultures.

Attend and you will be able to

• List key CGMP (current Good Manufacturing Practice) requirements/expectations
• Describe the unit operations commonly used for production of gene therapy vectors, including their purpose, underlying principles, and operation
• Culture adherent and suspension cell lines
• Optimize transient transfection conditions
• Harvest vector using scalable operations and describe options for harvest process design
• Purify vector using appropriate resins and AKTA chromatography systems
• Formulate drug substance by ultrafiltration
• Perform basic scale-up calculations for operations involved
• List parameters that are monitored and/or controlled to ensure acceptable process performance
• Calculate step yields for downstream operations
• Describe analytical tools used in assessing and characterizing gene therapy products and processes

Who should attend

Anyone interested in obtaining basic knowledge and hands-on exposure to production-scale biomanufacturing operations used in the manufacturing of vectors for gene therapy products, such as the following:

• New or existing biomanufacturing employees taking on a new assignment focused on gene therapy
• Research scientists from academia or industry interested in gaining knowledge of CGMP manufacturing of AAV vectors
• Biomanufacturing personnel who may not be directly involved with the process they support, including Validation, QA, or QC staff
• Suppliers of components and contractors providing services to companies manufacturing viral vectors

Attend and you will receive

• 30 hours of instruction
• Digital course materials
• Morning coffee and tea
• Lunch
• Afternoon beverage break
• Certificate of completion

Instructors

• Gary Gilleskie, Ph.D.
• Cristiana Boi, Ph.D.
• Driss Elhanafi, Ph.D.
• Elissa Hudspeth
• Danny Schmitt
• Suleiman Sweilem

Fee

$4,500

This course was developed with a project award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB17H002).

Additional support has been provided by the North Carolina Biotechnology Center.

Important Information for In-person Course Participants

Please read about BTEC’s policies on payment, cancellation, pre-course communication and other important information for in-person courses offered on site at BTEC.