• BTEC Short Courses: Biopharmaceutical Assay Essentials

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    Name: BTEC Short Courses: Biopharmaceutical Assay Essentials
    Date: July 21, 2020 - July 24, 2020
    Event Description:

    Why should you attend?

    Attend this course to gain a fundamental understanding of successful bioanalytical assay development and validation. This course is composed of primarily hands-on activities with some lecture. You’ll get hands-on experience with designing and developing an ELISA. After assay optimization, the ELISA will be validated by considering ICH guideline Q2(R1). You’ll gain an appreciation for the complexities involved in biopharmaceutical analysis and learn about troubleshooting, data analysis, and experimental design. You’ll also gain a fundamental understanding of analytical technologies used in biomanufacturing QC/analytical laboratories and get hands-on experience with HPLC, MALDI-TOF mass spectrometry, spectroscopy, and gel electrophoresis. In addition, you’ll gain an appreciation for the various tools available for biopharmaceutical analysis.

    Attend and you will learn

    Part 1

    • In-depth operation of ELISA
    • How to design, develop, optimize and validate an ELISA
    • Common protein conjugation strategies
    • Critical sources of variability in ELISAs
    • Bioanalytical method development and validation

    Part 2

    • Basic operation of HPLC, MALDI-TOF techniques
    • How to use peptide mass fingerprinting for protein characterization
    • Protein sizing techniques
    • Purity assessment
    • Basic assay design

    Who should attend

    • Professionals new to the biopharmaceutical industry or entering new work assignments encompassing analytical or QC environments
    • Professionals with previous QC/analytical experience who want to learn new techniques and/or broaden their understanding

    Attend and you will receive

    • 15 hours of instruction for each part (per part: 1.5 Continuing Education Units, CEUs; for both parts, 3.0 CEUs)
    • 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:
    July 21-24
    • Full four-day course: $2,400
    • Part 1 only (two days): $1,600
    • Part 2 only (two days): $1,600
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