QuiaPEG

Technology

 
PEGylation
Limitations on today's technology
QuiaPEG's advantages
R&D

Limitations on today's technology 

Current PEGylation methods have a number of critical drawbacks which may reduce their applicability in biopharmaceutical development. PEG synthesis results in a heterogeneous (“polydispersed”) end product which exhibits a range of molecular weights. This polydispersity is transferred to PEG-conjugated proteins and can make the formulation more prone to aggregation. Although infrequent, this aggregation may induce anti-PEG antibodies, particularly when repeated chronic doses of PEGylated proteins are given. These anti-PEG antibodies may potentially increase the clearance of the PEGylated protein, thus reducing its half-life instead of increasing it.

Ideally, the PEGylated protein is only coupled to a single PEG molecule and proteins coupled to two or more PEG molecules have to be removed from the end product. In addition, current PEG reagents produce unwanted PEG by-products with reactive/functional groups in both ends that enable cross-linking between two different proteins to occur or the coupling between two positions on the same protein, resulting in a heterogenic end product. The resulting impurities must be eliminated by lengthy and costly purification steps which could lead to a substantial loss of the therapeutic protein, translating into substantially higher cost of goods as well as problems establishing lot to lot consistency of the pharmaceutical product.

 

Contact
QuiaPEG Pharmaceuticals Holding AB

Virdings Allé 32 B
754 54 Uppsala
Sweden
+46 (0) 70 693 12 53
info@quiapeg.com

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