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Prediction of intraocular antibody drug stability using ex-vivo ocular model.

Eur J Pharm Biopharm. 2017; 
Patel Sulabh,Stracke Jan Olaf,Altenburger Ulrike,Mahler Hanns-Christian,Metzger Philipp,Shende Pankaj,Jere Dhana
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Recombinant Proteins stability of mAb Protein-L affinity chromatography (GenScript, Cat # L00239) was performed Get A Quote

摘要

Following intravitreal (IVT) injection, therapeutic proteins get exposed to physiological pH, temperature and components in the vitreous humor (VH) for a significantly long time. Therefore, it is of interest to study the stability of the proteins in the VH. However, the challenge posed by the isolated VH (such as pH shift upon isolation and incubation due to the formation of smaller molecular weight (M) degradation products) can result in artefacts when investigating protein stability in relevance for the actual in vivo situation. In this current study, an ex-vivo intravitreal horizontal stability model (ExVit-HS) has been successfully developed and an assessment of long-term stability of a bi-specifi... More

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