Challenge:
How similar is the biosimilar to its innovator?
Solution:
Rapid and reliable analytical tools and methods to check and confirm molecular similarity required by regulators.
1) 3 �m Zenix� SEC-300 is used to characterize the MW of the biosimilar and its innovator, and further quantify their aggregates.
2) Antibodix� and Proteomix� provide high resolution separation of the biosimilar and its innovator, especially for charge heterogeneity analysis as well as glycosylation changes.
Case Study:
A biosimilar shows good match of MW and aggregates profile with its innovator, Erbitux, as shown in Fig. 1. However, their fine structures of the charge variants are very different on Antibodix� WCX, as shown in Fig. 2. Fig. 3 shows further improved resolution for Erbitux charge variants with Proteomix� SCX phase as strong cation (SCX) and weak cation (WCX) phases offers different selectivity and resolving power for each specific sample.
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Fig. 1. Size exclusion separation profile of Erbitux and a biosimilar
Column: Zenix� SEC-300
( 3 �m, 300 �, 7.8 x 300 mm )
Mobile phase: 150 mM Sodium
Phosphate, pH 7.0,
Flow rate: 1.0 mL/min,
Detector: UV 280 nm,
Column temperature: 25�C,
Pressure: 74 bar,
Sample: 10 �g of 5 mg/mL Erbitux and 2mg/mL biosimilar
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Fig. 2. Charge heterogeneity analysis of Erbitux and its biosimilar by ion Exchange chromatography
Column: Antibodix� WCX NP5
( 5 �m, 4.6 x 250 mm)
Mobile phase A: 10 mM Phosphate buffer,
pH 7.5, B: A + 0.5 M NaCl,
Flow rate: 0.8 mL/min,
Detector: UV 214 nm,
Column temperature: 30�C,
Pressure: 162 bar,
Sample: 2 �L of 5 mg/mL Erbitux and 5 �L 2mg/mL biosimilar
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Fig. 3. Erbitux Separation on Antibodix WCX and Proteomix SCX
Column: Antibodix� WCX NP5
Proteomix� SCX NP5
( 5 �m, 4.6 x 250 mm)
Mobile phase A: 10 mM Phosphate buffer,
pH 7.5, B: A + 0.5 M NaCl,
Flow rate: 0.8 mL/min,
Detector: UV 214 nm,
Column temperature: 30�C,
Pressure: 162 bar,
Sample: 2 �L 5 mg/mL Erbitux
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REDEEM
AND SAVE
20%
Promo Code: AUGUST20
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Choose 2 from below columns and get 20% OFF
Zenix� SEC-300, 3 �m, 300 �, 7.8 x 300 mm (P/N 213300-7830)
Proteomix� SCX NP5, 5 �m, 4.6 x 250 mm (P/N 401NP5-4625)
Proteomix� WCX NP5, 5 �m, 4.6 x 250 mm (P/N 402NP5-4625)
*Full list price purchase only; Limit one coupon per purchase; Cannot be combined with any other offers; Direct purchase only and not applicable through distributors; All columns have to be purchased in one Order; Promo cannot be applied to past orders; Promo purchase cannot be returned; All rights reserved by Sepax; Offer valid through 09/20/2014.
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