Microsampling

PHARMA:

KCAS Bio has vast experience that spans over 45 years in bioanalytical assay development and over 25 years in LC-MS/MS method development, validation and sample analysis for both non-GLP and GLP applications.  Combining this experience with microsampling, we have what it takes to develop quantitative bioanalytical assays for several molecular types.

When pivoting from traditional blood collection assays to microsampling assays, we need to consider parameters such as dry blood spot minimum drying time, logistics of lab preparations/sample extractions, temperature condition for sample handling and shipment, sample extraction starting with DBS (dried blood spot) plug/spot, lot to lot variability of microsampling devices, and hematocrit effect.

BIOPHARMA:

Blood microsampling using ligand-binding assays is an innovative technique that enables the collection of small blood volumes for the analysis of biomolecular interactions. This method involves the use of minimally invasive procedures to obtain microsamples, which are then analyzed using ligand-binding assays to measure the concentration and activity of specific ligands or biomarkers in the blood. The advantages of this approach include reduced sample volume requirements, increased patient comfort and compliance, and the potential for more frequent sampling in clinical and research settings. This technique is particularly useful for pharmacokinetic and pharmacodynamic studies, offering accurate and reliable data while minimizing the impact on the subject.

Supporting our clients in using blood microsampling with ligand-binding assays can be achieved through a multi-faceted approach. Some of these strategies include Education Resources, Technical Support, Customized Solutions, Quality Assurance, Regulatory and Compliance Support, and Continuous Improvement.

Pros of Microsampling:

• Minimally invasive (less pain, uses capillary blood versus venous blood).  Supports low sample volumes for studies where sample volume is critical by omitting plasma separation step (~50% of whole blood volume), e.g. Rodent Studies (specifically mice) and Pediatric Studies.
• For clinical studies, subjects can perform the blood collection at home without the need for a licensed Phlebotomist.
• Remote locations are more easily accessible without the need to visit a clinic or have the infrastructure of traditional blood collection processes.
• Easy multiple sample collection for repeat analysis (e.g. sample repeats, ISRs, and multiple assays). For example, each Tasso-M20 device has a total of four dry blood spots with a fixed collection volume of approximately 17.5 µL each.  Or if using Mitra VAMS, each package is bundled as two or four tips and each can hold 10, 20, or 30 µL of blood.

Potential Cost Avoidance:

• No need for expensive lab equipment and their regular maintenance such as -70°C deep freezers or Centrifuges
• No need for whole blood vacutainers and associated blood collection supplies in addition to secondary sample containers
• Fewer staff needed for blood collections; Phlebotomist not required
• Samples are shipped at room temperature avoiding the cost of dry ice or a cooler
• Samples are not classified as hazardous material and therefore lower cost of shipping

Potential Cons of Microsampling:

• Reliance on human subjects for collecting blood samples accurately and consistently
• No staff to monitor proper collection and compliance with the study protocol
• Additional Lab space for storage of microsampling plugs/spots/Mitra VAMS tips is needed
• Temperature / humidity fluctuations during collection (different climates) and shipping
• Hematocrit effect could be an issue for people with certain diseases / molecular types (anemia for instance)