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.
Diverse Sample Types
- Whole Blood: We specialize in the direct analysis of whole blood samples, preserving the native cellular environment for accurate assessments of immune cell populations, platelet function, and cytokine levels. This approach is particularly valuable for studies requiring minimal sample manipulation, such as immuno-phenotyping and platelet-leukocyte aggregate analysis in thrombo-inflammatory research
- PBMCs (Peripheral Blood Mononuclear Cells): Utilizing density gradient centrifugation or automated isolation methods, we extract PBMCs from blood samples with >95% cell viability. This enables detailed studies of lymphocytes, monocytes, and other immune cells for applications including receptor occupancy assays, T-cell exhaustion analysis, and CAR-T cell characterization. PBMC-based assays are essential in immuno-oncology, autoimmune research, and vaccine development.
- BMMCs (Bone Marrow Mononuclear Cells): Our lab also has the capability to process bone marrow samples to isolate BMMCs for high-resolution analyses of hematopoietic progenitor cells, leukemic blasts, and other rare populations. This capability supports translational research in hematological malignancies, regenerative medicine, and bone marrow transplant monitoring.
Customization and Flexibility
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 of Platelet Function Testing
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.