Reducing sample volumes for bioanalysis
Improvements in bioanalytical techniques have reduced the amount of sample required for the assessment of drugs and biomarkers in blood, plasma and serum. This has opened the opportunity to employ microsampling devices that obtain samples of ≤50µL. There are a myriad of drivers for employing this approach: • Better profiling in preclinical studies as multiple endpoints are obtained from a single animal.
- To support the 3Rs approach by enabling reduction and refinement in animal studies.
- To aid sampling in at-risk patient subsets, for example paediatric, critically ill or remote patients.
- Studies looking to employ Patient centric/Home sampling.
- Improved stability and simplified storage requirements (in some cases).
At Drug Development Solutions we advocate the principles of the 3Rs (Replacement, Reduction and Refinement) framework for performing more humane animal research. As such we have developed our capabilities for the bioanalysis of preclinical microsamples (≤50μL), be it from capillary liquid sampling or dried matrices.
Clinical trials involving vulnerable patient groups or diseases that are acute in nature can also benefit from the deployment of patient centric microsampling that enables remote or at home sampling. Our team have created optimisation and validation protocols to ensure the rapid development of bioanalytical methods for the measurement of pharmaceuticals, biopharmaceuticals and biomarkers from patient centric sampling devices.
The smaller sample sizes and dried matrices involved with microsampling potentially offer faster turnaround, ease of sampling, storage, and shipment. Additionally, the use of patient centric devices can improve subject recruitment, retention and the ability to run trials in geographically challenging environments.
As an active member of the European Bioanalytical Forum microsampling project and Patient Centric Sampling Interest Group (PCSIG), we have experience with a range of techniques and devices including:
- Dried blood spots
- Capillary liquid microsampling
- Volumetric absorptive microsampling (VAMS)
Our Drug Development Solutions team can advise on which technique may be most appropriate for your study. We can support studies employing microsampling devices with regulatory method development, validations and sample analysis along with any subsequent bridging of sampling techniques that may be required.
Our Immunogenicity Centre of Excellence has utilised microsampling for our COVID-19 antibody assay. Using Neoteryx’s Mitra® microsampling device samples can be collected at home without the need for a healthcare professional.