Whole blood stability evaluation of monoclonal antibody therapeutics using volumetric absorptive microsampling
Li et al.
The finding, in our words
The study found that daclizumab and trastuzumab showed encouraging recovery from VAMS after short term storage at room temperature and long term storage at -80 degrees Celsius, supporting the use of VAMS for therapeutic drug monitoring of biologics in decentralised settings.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The authors developed and validated a workflow that couples Mitra volumetric absorptive microsampling with hybridisation LC-MS/MS to quantify the antisense oligonucleotide fomivirsen in human blood. Quantitative recovery was achieved irrespective of haematocrit level or sample age, and the method demonstrated sensitivity, linearity, precision, accuracy, and four-month stability, supporting its use for therapeutic drug monitoring of biologic candidates in decentralised trials.
VAMS coupled with LC-MS/MS showed good correlation with conventional serum sampling for monoclonal antibody pharmacokinetics in rhesus monkeys, but a subsequent clinical study revealed that EDTA anticoagulant in standard and quality control samples caused anomalous internal standard responses in patient fingerstick samples, compromising accuracy. The authors recommend specific best practices during method development and validation to detect such anticoagulant effects early before deploying VAMS in clinical studies.
The Mitra® microsampler demonstrated good recovery of seven therapeutic monoclonal antibodies from capillary blood after storage at room temperature for one month, with marginally better performance than conventional dried blood spot cards. This validates a practical protocol for decentralised therapeutic drug monitoring of biologic therapies.
In lung and renal transplant recipients, VAMS sampling with LC-MS/MS quantification of mycophenolic acid and tacrolimus showed good linearity and accuracy, and with a haematocrit-adjusted conversion formula achieved clinical agreement in most samples; tacrolimus did not require haematocrit correction. The approach is virtually painless and enables richer sampling for more accurate drug exposure estimates, supporting decentralised therapeutic drug monitoring.
This review found that volumetric microsampling devices, such as Mitra, HemaPEN, HemaXis DB10, and Tasso-M20, overcome haematocrit bias, whilst Telimmune plasma separation cards enable direct plasma collection without centrifugation. These technologies support patient-centric, decentralised sampling, though the authors note that clinical validation remains limited across different drugs and patient populations.