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 stand-alone, or as part of a complete development program.
Our Microsampling Expertise
Our laboratory services include innovative supporting processes 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)
Benefits of Microsampling
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
- 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
- Blog — Making a Difference in Drug DevelopmentBlog — Making a Difference in Drug DevelopmentBlood microsampling is a less invasive and simplified alternative to traditional venipuncture, and provides significant advantages in preclinical and clinical studies alike.
- 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.
- 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.
Learn more about our laboratory services
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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.