Application of Mitra ^® Microsampling for Pharmacokinetic Bioanalysis of Monoclonal Antibodies in Rats

Abstract

Aim: Volumetric absorptive microsampling (VAM) is being increasingly applied in nonclinical pharmacokinetic studies. Although there are published results for VAM use in small molecule pharmacokinetics (PK) studies, there is limited data on the utility of VAM for protein therapeutics. Results: We describe the use of Mitra® microsampler for blood sampling, ELISA quantitation and PK analysis of two marketed therapeutic monoclonal antibodies administered to rat. Results generated for these monoclonal antibodies using Mitra® were compared with both serum and whole blood sampling methods in the same study. Conclusion: The low relative standard deviation among the three sets of PK data suggest that Mitra® microsampler could be useful in early nonclinical PK studies for protein therapeutics where reduction and refinement of animal use is desirable.

Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials

“…The quantitation of trastuzumab and daclizumab was achieved using ELISA. Three PK data sets obtained by serum, liquid whole blood and Mitra were compared and found in good agreement 101 . Another study was conducted on 19 patients who were treated with vedolizumab.…”

Barriers and opportunities for the clinical implementation of therapeutic drug monitoring in oncology

“…the above‐mentioned haematocrit issue) by enabling precise volumetric sampling. In the field of TDM with anticancer drugs, 2 volumetric absorptive microsampling‐based methods have been reported: for mitotane 73 and for the determination of 2 monoclonal antibodies in preclinical pharmacokinetic studies 74 . Bhatnagar et al 75 have also published a method for the monitoring of abiraterone and its active metabolite using dried plasma spots.…”

“…In the field of TDM with anticancer drugs, 2 volumetric absorptive microsampling-based methods have been reported: for mitotane 73 and for the determination of 2 monoclonal antibodies in preclinical pharmacokinetic studies. 74 Bhatnagar et al 75 Nonetheless, the reality is that for many oncology treatment centres, particularly those in developing countries and remote areas, local access to these highly sensitive methods for oncology TDM is out of reach. However, unlike the immediate dose adjustment required for the TDM of antimicrobials, for many anticancer medicines a moderate temporal delay between sample collection and availability of results is acceptable, particularly for those drugs with regimens that incorporate drug-free periods (such as sunitinib) or are only administered at the beginning of each treatment cycle (e.g.…”

Emerging trends in paper spray mass spectrometry: Microsampling, storage, direct analysis, and applications

“…al. first devised the VAMS device, and since commercially named Neoteryx's Mitra (Kovač et al, ; Taylor et al, ; Li et al, ), in 2014 to address the major issues of DBS, most notably the hematocrit effect, sample volume bias, and inhomogeneity. In its simplest form (Fig.…”