• BTEC Short Courses: Hands-On cGMP Biomanufacturing of Vectors of Gene Therapy

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    Name: BTEC Short Courses: Hands-On cGMP Biomanufacturing of Vectors of Gene Therapy
    Date: August 3, 2020 - August 6, 2020
    Event Description:

    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 support personnel who may not be directly involved with the process they support
    • Vendors who supply the biomanufacturing industry with equipment and components

    Attend and you will receive

    • 30 hours of instruction (3.0 Continuing Education Units)
    • Notebook containing all course lecture and lab materials
    • Morning coffee
    • Lunch
    • Afternoon beverage break
    • Certificate of attendance
    All courses are offered on site at BTEC, other than online courses. The Golden LEAF BTEC building is located at 850 Oval Drive on NC State University's Centennial Campus.
    Date/Time Information:
    August 3-6
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