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    Semaglutide Bioassay Kit - Qualification Data

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    kennylee0001

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    Semaglutide Bioassay Kit - Qualification Data

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    kennylee0001
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    Semaglutide-Bioassay-Kit_Qualification-Data

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    48 views11 pages

    Semaglutide Bioassay Kit - Qualification Data

    Uploaded by

    kennylee0001

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 11

    cAMP Hunter® Semaglutide

    Bioassay
    Qualified with Ozempic®
    95-0062Y2-00175 (2-Plate Kit)
    95-0062Y2-00176 (10-Plate Kit)

    Victoza® is the registered trademark of Novo Nordisk A/S


    Semaglutide (Ozempic®)
    For Treatment of Type II Diabetes mellitus

    Mechanism of Action Assay Principle

    Source: Sebastião et. al., Front. Endocrinol. (2014); 5, 110

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential
    cAMP Hunter® Semaglutide Bioassay Kit

    Kit Components

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential 3
    Sample data

    Semaglutide Bioassay Qualification

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential
    Bioassay Workflow
    Simple, Homogenous and Rapid Protocol

    Plate Read-to-Use Cells Treat with Agonist/ Molecule Read Luminescence

    Add Detection Add cAMP


    Solution Solution
    24 h 30 min 1h 3h

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential
    Optimized Semaglutide Dose Curve and Plate Layout
    For Assay Qualification

    Dilution Scheme Representative Dose Curve Plate Layout


    Concentration, Diln
    (100%)
    ng/mL Factor
    3 30000
    1 3
    0.33 3
    0.11 3 20000
    RLU

    0.056 2
    0.037 1.5 10000
    0.025 1.5
    0.012 2
    0
    0.0062 2
    10 -13 10 -12 10 -11 10 -10 10 -9 10 -8
    0.0031 3
    [Semaglutide], g/mL
    0.00078 4

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential 6
    Day-to-Day Repeatability with Semaglutide (Single Analyst)

    Day 1 Day 2 Day 3


    CH CHO-K1 GLP1R Bioassay CH CHO-K1 GLP1R Bioassay CH CHO-K1 GLP1R Bioassay
    Part #: 95-0062Y2 Lot #: 22A2806 Part #: 95-0062Y2 Lot #: 22A2806
    Part #: 95-0062Y2 Lot #: 22D1208
    30000 30000 30000

    20000 20000 20000


    RLU

    RLU

    RLU
    10000 10000 10000

    0 0 0
    10 -13 10 -12 10 -11 10 -10 10 -9 10 -8 10 -13 10 -12 10 -11 10 -10 10 -9 10 -8 10 -13 10 -12 10 -11 10 -10 10 -9 10 -8
    [Semaglutide], g/mL [Semaglutide], g/mL [Semaglutide], g/mL

    Day 1 Day 2 Day 3 % RSD


    S/B 15.8 13.9 16.3 8.3%
    EC50,
    34.8 29.7 34.1 8.4%
    pg/mL

    Note: consistent data generated with two different bioassay lots


    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential 7
    Representative Relative Potency Data (4 Nominal Concentrations)
    (Analyst 1 vs Analyst 2)
    50% 75% 125% 150%
    50% 78.9% 116.7% 149.1%
    Analyst 1

    47.3% 74.4% 114.8% 151.9%


    Analyst 2

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential 8
    Semaglutide Bioassay Qualification Data
    Nominal Observed RP, Average Average %
    RP, % Analyst % RP, % % RSD Recovery
    Semaglutide Bioassay Dilutional Linearity

    Measured Relative Potency %


    1 149.1 200 (50%-150%)

    150 1 138.8 143.9 5.4 95.9% R2= 0.9990


    150
    1 135.8
    2 151.9 100
    1 130.7
    1 116.7 50
    `125 119.4 6.4 95.5%
    1 115.2 0
    2 114.8 0 50 100 150 200
    Expected Relative Potency, %
    1 108
    1 101.1 Parameter Value Specification
    100 1 88.1 98.8 7.8 98.8%
    1 94.4 Accuracy
    (Average % Recovery) 97% 100% +/- 20%
    2 102.3
    1 73.5 Repeatability 8.7% ≤20%
    1 79.0
    75 72.8 8.5 97.1% Intermediate Precision ≤8.5% ≤20%
    1 64.3
    2 74.4 Linearity (R2) 0.9990 ≥0.95
    1 47.3
    Excellent accuracy, repeatability, intermediate
    1 51.1
    50 48.9 3.9 97.9% precision, and dilutional linearity
    1 50
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    Confidential Confidential 9
    2 47.3
    Benefits for “Ready-to-Use” Bioassay Kits

    Functional response based on drug MOA


    Verified and Qualified with innovator’s marketed drug
    Simple protocol; Rapid results
    Specific and Sensitive assay
    Highly reproducible

    Readily Implement with Optimized kit


    • Frozen ready-to-assay cells
    • Bioassay Detection Reagents
    • Cell Plating Reagent
    • Dilution Buffer
    • Control Agonist
    • Tissue Culture-Treated Plates

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential
    For More Info, Questions or Technical Support

    Web:
    Cell-Based Bioassays for Biologics

    Technical Support
    [email protected]

    Drug Discovery & Development Phase-Appropriate Solutions | Our Expertise in Your Hands – Discover Confidently Confidential Rev: 20180410

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