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G1006465

HPLC Analysis of Humira on BIOshell A400 Protein C4 Column

application for HPLC

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technique(s)

HPLC: suitable

test parameters

column: BIOshell A400 Protein C4, 10 cm x 2.1 mm, 3.4 μm particles (66825-U)
mobile phase: [A] 80:20, (water, 0.1% TFA): (acetonitrile, 0.1% TFA); [B] 50:50, (water, 0.1% TFA):(acetonitrile, 0.1% TFA).
gradient: 45 to 57% B in 12 min
flow rate: 0.2 mL/min
pressure: 2450 psi (for Competitor A), 1230 psi for BIOshell (169 bar (for Competitor A), 85 bar for BIOshell)
column temp.: 75 °C
sample: 0.3 μL Humira

suitability

application for HPLC

application(s)

life science and biopharma

Analysis Note

Humira is a biotherapeutic used to treat rheumatoid arthritis (RA), ulcerative colitis (UC), and chronic plaque psoriasis (Ps). Analysis of the mAb′s monomors, aggregates, and fragments was performed on a BIOshell A400 Protein C4 column as well as a comparable column on the market. The BIOshell A400 Protein C4 column shows greater retentivity as well as greater resolution of the monomer from the aggregates and drug fragments. Peak recoveries were essential equivalent for the two columns.

Other Notes

mAb diluted in 20 mM Tricine/KOH, pH 7 to 1 g/L

Legal Information

analytical column

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