Microsampling in Early Phase Drug Development
Altasciences’ bioanalytical scientists and study experts leverage innovative microsampling technology that allows low volume blood draws to be taken from test subjects for analysis. We have developed specialized methods and workflows that take full advantage of current microsampling technology at the preclinical, clinical, and bioanalytical levels, and support the efficient advancement of your drug development program. Our microsampling services are fully customizable, available as a standalone, or as part of a complete development program.
Microsampling Applications in Bioanalysis
Sample Types
- Blood (capillary, venous)
- Plasma and serum
- Other bodily fluids, like saliva or urine (where relevant to the study)
Microsampling Techniques
- Dried Blood Spot (Capitainer® qDBS): Collection of blood drops on filter paper for easy storage and transport
- Volumetric Absorptive Microsampling (Mitra ®VAMS®): Allows precise volume control and improved handling for quantitative bioanalysis
- Capillary Microsampling: Small capillary tubes to collect small blood volumes without venipuncture
Applications in Biomarker Research
- Microsampling supports biomarker discovery and validation by enabling small-volume sampling in large cohorts
- Suitable for population studies and chronic disease monitoring where frequent sampling over time is necessary
Our bioanalytical laboratory services include innovative workflows for microsampling, including:
- Specially designed sample storage and retrieval system to facilitate passing of ISR according to FDA guidelines
- State-of-the-art sensitivity and high-throughput bioanalytical capabilities utilizing UHPLC combined with the SCIEX 6500+ Triple Quad MS system
- Impact-assisted extraction to ensure an unbiased and maximal recovery of analyte from the Mitra® substrate for both large and small molecules (published article)
Watch a microsampling video that explains the low volume blood draw process, and our capabilities.
Consult our microsampling fact sheet for more information and access to our microsampling scientific posters and publications.
Advantages of Microsampling for Clinical Trials and Preclinical Studies
Microsampling provides distinct benefits throughout the early phase drug development continuum.
- Reduces stress on research animals due to rapid, straightforward, minimally invasive blood collection
- Improves scientific quality of TK profiles via serial sampling from the same animal rather than composite sampling from several cohorts
- Permits direct correlation of study findings in individual animals by use of main study animals only; no satellite animals required
- Reduces blood volume significantly compared to regular venous sampling – enables PK studies in children and neonates, or those with difficult venous access or needle phobia
- Allows self-sampling at home or in remote geographic locations
- Enriches PK trial data with samples taken for additional assessments and facilitates episodic sampling
- Mitigates the challenges associated with traditional liquid matrices such as plasma (e.g. cold chain shipping, storage, and sample processing)
- Potential to accelerate method development and sample throughput
- Improves compound stability in dried blood matrices for some drug classes
Related Resources
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Educational Video—Strategic Approach to Microsampling Device Selection and Associated WorkflowsEducational Video—Strategic Approach to Microsampling Device Selection and Associated WorkflowsPresented at the PBSS/PCSIG webcast -
Poster — Preclinical Strategies Using VAMS®Poster — Preclinical Strategies Using VAMS®The adoption of blood microsampling as the preferred collection technique for the entirety of a drug development program has increased -
Research Article—Microsampling in Pediatric StudiesResearch Article—Microsampling in Pediatric StudiesMicrosampling in pediatric studies: pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies. -
Research Article—Method for Quantification of ASOs in Mouse SerumResearch Article—Method for Quantification of ASOs in Mouse SerumA validated capillary microsampling liquid chromatography–tandem mass spectrometry method for quantification of antisense oligonucleotides in mouse serum. -
Podcast — Microsampling: When Small Steps Lead to Big OutcomesPodcast — Microsampling: When Small Steps Lead to Big OutcomesIn this podcast our special guest Dr. Don Chace, Capitainer, talks about some of the most pressing drug development topics. -
Coupling Hybridization LC-MS Workflows with MicrosamplingCoupling Hybridization LC-MS Workflows with MicrosamplingEpisode 2 of our Microsampling series -
The Evolution of Microsampling with the MITRA® VAMS® DeviceThe Evolution of Microsampling with the MITRA® VAMS® DeviceEpisode 3 of our Microsampling podcast series -
The Altascientist — Microsampling Applications in Early Phase Drug DevelopmentThe Altascientist — Microsampling Applications in Early Phase Drug DevelopmentLow-volume, minimally invasive blood draws (microsampling) can have beneficial impact throughout the phases of drug development.
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THERAPEUTIC AREAS
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.