Harmonized Flow Cytometry Solutions for Clinical Trials
Global Harmonization and Compliance
MLM Medical Labs adheres to stringent global standards, including GCLP, to ensure seamless integration of its flow cytometry services into global clinical trials.
With in-house flow cytometry capabilities in both the United States and Europe, MLM Medical Labs ensures that assays are validated and globally harmonized in accordance with CLSI H62 guidelines, thereby reducing variability and enhancing consistency across all locations.
Integrated Global Gating and Quality Control
- MLM Medical Labs' global gating strategies ensure reproducibility across multiple sites for diverse sample sets through automated, standardized procedures, enabling seamless integration of datasets to support global trials.
- The precision of instrument settings across multiple continents is ensured through daily instrument calibrations, standardized protocols, and stringent quality assurance processes, minimizing variability and guaranteeing data accuracy.
State-of-the-Art Technology
State-of-the-art flow cytometry technology is utilized to provide multi-color capabilities (up to 20 colors) and high sensitivity for detailed phenotypic and functional analyses.
Customization and Flexibility
Bespoke assay solutions are developed to meet the unique requirements of each clinical trial, supporting a wide range of therapeutic targets, including CAR-T cell therapies and autoimmune disease research. Flexibility is demonstrated through the adjustment of sample handling procedures, optimization of panel designs, and incorporation of newly identified biomarkers, ensuring maximum adaptability for the diverse drug targets being developed for precision medicine.
Receptor Occupancy
Flow cytometry-based receptor occupancy assays are designed to address critical challenges faced by clinical trial sponsors. Utilizing state-of-the-art platforms and scientific expertise, the following services are provided:
- Quantitative & Qualitative Analysis: Comprehensive data on the percentage and intensity of receptor occupancy.
- Dynamic Range Assessment: Precise results even at high and low receptor expression levels.
- Custom Assay Development: Tailored assays to fit specific trial needs, using antibodies specific to your investigational drug.
- Multiplexed Analysis: Simultaneous measurement of multiple receptor states for complex trials.
Platelet Function Testing
Flow cytometry-based platelet function testing services deliver precision analysis essential for clinical trials in cardiovascular, autoimmune, and oncology fields. Leveraging advanced flow cytometry technology, these services provide rapid, multiparameter insights into platelet activity and thrombo-inflammatory processes, supporting the development of safe and effective therapeutics.
Key Capabilities
Measures key platelet activation markers, including CD62P (PSelectin) for alpha granule release and CD63 for dense granule release, enhancing sensitivity and accuracy over traditional methods.
Evaluates thrombo-inflammatory activity, offering insights into platelet interactions with immune cells like monocytes and neutrophils.
Supports cardiovascular trials by measuring the inhibition of platelet activation, crucial for assessing antiplatelet therapies.
