Non – LCMS, Non – LBA Based Challenging and Innovative Bioanalytical Methods
01 Jun 2020
In the recent past Lambda got an opportunity to work on two unique bioanalytical methods for drug products viz. an intravenous Iron supplement and a Low Moleculat Weight Heparin Product.
The regulatory requirement for measuring PK of the Iron product is to measure serum levels of Total Iron (TI) and Transferrin Bound Iron (TBI). The most reported and traditional method for determination of TI and TBI are based on ICP-MS. Lambda developed and validated a PK measurement method for Iron product based on in-vitro diagnostic (IVD) platform which is commonly used in diagnostic laboratories to measure biochemistry parameters. Lambda team had utilized the module