New method development for PK and immunogenicity for large molecule
12 Nov 2018
Lambda has successfully developed and validated bioanalytical methods to support pharmacokinetics measurement and immunogenicity assessment of Romiplostim. Romiplostim is a fusion protein analog of Thrombopoietin and is indicated for treatment of chronic idiopathic (immune) thrombocytopenic purpura (ITP).
The pharmacokinetic measurement assay is a sandwich ELISA based ligand binding assay, which employs anti-romiplostim antibody as capture and biotin conjugated anti-romiplostim antibody as detection reagent. The endpoint is colorimetric and is measured in terms of Optical Density. The assay is extremely sensitive with the lowest limit of quantification at 40 pg/mL and is selective and specific to detect and quantify low serum levels of romiplostim.
An electro-chemiluminescence immunoassay (ECLIA) has been developed for immunogenicity assessment of romiplostim. The assay is based on bridging format and employs biotin conjugated romiplostim and sulfotag conjugated romiplostim for capture and detection of anti–romiplostim antibodies, respectively.
The bioanalytical romiplostim methods were used to support a Phase III trial of the biosimilar of N-Plate (Amgen Inc.) and the results obtained were corroborating with the reported data of N-Plate by Amgen Inc.