Dried Blood Spot (DBS) is an analytical technique gaining acceptance as a superior alternative to traditional plasma collection in both preclinical and clinical drug development studies. At KCAS, we present this service in an effort to provide both accurate and reliable results with the potential of dramatically reducing overall study costs. Many drug development companies find advantages to using this technique; especially for preclinical toxicology studies, clinical pediatric studies, and studies conducted in remote geographic areas where centrifuges and freezers are not readily available.
DBS offers several distinct advantages over conventional blood collection, due in part to the limited amount of blood required (25-40 mcL per spot).
- Toxicology – The limited sample volume needed reduces the number of animals required for toxicokinetic (TK) or pharmacokinetic (PK) studies. This not only cuts animal costs, but inherently improves PK profiles since you can collect multiple sample timepoints per animal.
- Pediatrics – Utilizing this technique reduces anxiety in young children by using a lance or heel prick instead of venous blood drawn with a needle.
- Global Trials – Ideal for outlying and underdeveloped areas due to the fact centrifuges, freezers and electricity are not needed. Shipping costs are also reduced because there is no longer a need for large quantities of dry ice.
- Therapeutic Drug Monitoring – Similar to diabetic patient glucose monitoring, DBS has the potential for applications of monitoring therapeutic levels of drugs in the blood stream. Patients can simply place the card into an envelope and mail it directly to the lab.
As with any technique, there are limitations in DBS because of the small amount of blood used and the physical process in drying.
- Assay Sensitivity – Concentration requirements below 1 ng/mL may be better suited using conventional plasma or whole blood collection.
- Unstable Compounds – Inherently unstable drugs may degrade during drying process.
- Large Molecule Compounds – DBS has been used for enzyme and protein assays but the physical process of drying may damage and limit extraction of the molecule from the dried matrix.
- Variation in Hematocrit – Patient or animal blood with either low or high hematocrit levels can cause inconsistent spotting on cards. New DBS cards have been introduced using a fiberglass format that may overcome this issue.
- Regulatory Acceptance – The FDA has not officially weighed in on its use for new applications but is expected to finalize an opinion in 2013.
DBS at KCAS
KCAS has the expertise to support your preclinical and clinical studies by providing a full range of bioanalytical services. Talk with us to learn more about this technique and if DBS is a good fit for your drug development program. Let us leverage our 33 year history of scientific expertise and our problem solving mindset to work on your most challenging research questions.
The services we provide to support DBS programs include:
- Method Development
- Method Validation
- Preclinical Sample Analysis – non-GLP or GLP and GCP
- Clinical Sample Analysis
- Clinical Sample Collection Kits and Shipping Supplies
- Long-term Sample Storage