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PEGylation of rhIL-1RA increased its solution stability at room temperature

Paper ID Volume ID Publish Year Pages File Format Full-Text
35299 45085 2009 6 PDF Available
Title
PEGylation of rhIL-1RA increased its solution stability at room temperature
Abstract

Recombinant human interleukin-1 receptor antagonist (rhIL-1RA) is an important cytokine in the treatment of inflammatory diseases. However, it is instable in aqueous solution and prone to degrade without the addition of any excipient. Following the 30- or 60-day storage in 50 mM sodium acetate (pH 5.0) at room temperature, rhIL-1RA markedly degraded into three species (denoted as P1, P2 and P3 in this study), the bioactivities of which to a different extent was lost (from 9.72 × 104 UI/mg to 3.07 × 103 UI/mg for P1, 5.49 × 103 UI/mg for P2, 1.09 × 104 UI/mg for P3, respectively). To solve this problem, we prepared the mono-PEGylated rhIL-1RA with propionaldehyde mPEG (ALD-PEG, Mw 5000 Da). The conjugate showed more favorable stability than original protein, and remained homogeneous under the similar storage conditions. In addition, the activity of the conjugate was well retained (from 5.80 × 104 UI/mg to 4.92 × 104 UI/mg), compared to that of original protein. The results based on the combination analysis of CD, ion exchange chromatography and RP-HPLC, revealed that the stability improvement of rhIL-1RA majorly benefited from the PEG strands protection against the protein conformational changes occurred during the storage.

Keywords
Recombinant human interleukin-1 receptor antagonist; PEGylation; Aqueous stability; Conformational changes; Chromatography
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Publisher
Database: Elsevier - ScienceDirect
Journal: Process Biochemistry - Volume 44, Issue 12, December 2009, Pages 1340–1345
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us