• 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
    Location:
    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
    Fees/Admission:
    $4,000
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