Harmonized Flow Cytometry Services for Clinical Trials
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
Our 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.
The Industry's Latest Technology
Our flow cytometry platforms are utilized to provide multi-color capabilities — up to 20 colors — and high sensitivity for detailed phenotypic and functional analyses. They include:
- BD Biosciences FACSLyric: The FACSLyric flow cytometry system provides immunophenotyping data, confirms receptor or target occupancy, monitors minimal residual disease (MRD) and performs neutralizing antibody (nAb) assays (up to 14 colors).
- BD Biosciences FACSMelody: An advanced automated cell sorting system, FACSMelody streamlines the isolation of cell populations to provide deep scientific insights.
- Cytek Northern Lights-2000: Northern Lights is a full-spectrum flow cytometry system that captures up to 20 colors for a detailed analysis of target cells and drug effects.
Diverse Sample Types
Our labs are equipped to process and analyze a wide range of sample types, providing flexibility to support diverse clinical and preclinical research needs. These include:
- 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 immunophenotyping and platelet-leukocyte aggregate analysis in thrombo-inflammatory research
- Peripheral blood mononuclear cells (PBMCs): 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.
- Bone marrow mononuclear cells (BMMCs): 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.
Custom Assays 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 Assays
Our 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, we provide the following services:
- Quantitative and 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 our platelet function testing include:
- Comprehensive marker analysis: 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.
- Platelet-leukocyte aggregate analysis: Evaluates thrombo-inflammatory activity, offering insights into platelet interactions with immune cells like monocytes and neutrophils.
- Optimized drug monitoring: Supports cardiovascular trials by measuring the inhibition of platelet activation, crucial for assessing antiplatelet therapies.
Additional Flow Cytometry Assay Capabilities
We offer a broad range of flow cytometry assay capabilities, enabling us to provide detailed analyses in accordance with your protocol requirements. Our instrumentation suite also allows our teams to swiftly adapt to trial needs as they evolve. We utilize flow cytometry technology to perform the following:
Gain an early understanding of your drug’s mechanism of action or discover new biomarkers with exploratory biomarker testing. We can design and validate complex flow cytometry panels to explore numerous biomarkers simultaneously or develop custom assays for novel targets.
Rapidly detect changes in safety biomarkers like alanine aminotransferase (ALT), troponin and creatinine to mitigate potential toxicity. Access lab data in real time through our web-based portal, mlm online®, to address risks promptly.
Make data-driven decisions about drug dosage by measuring its effect on cell signaling and receptor occupancy with a pharmacodynamics (PD) assessment. Our expertise in developing and validating complex PD assays, like our receptor occupancy assays, provides reliable data to support accelerated drug development.
Why Choose Our Flow Cytometry Laboratory for Trial Analysis?
Since 1993, we’ve supported therapeutic development and empowered biotech and biopharmaceutical companies with high-quality laboratory services and agile, science-driven solutions. We offer:
- Adaptable experts: Our expert team quickly responds to protocol amendments, integrating changes seamlessly to keep your trial on track.
- End-to-end support: We offer complete laboratory support at every stage of drug development, from preclinical studies through Phase IV trials.
- Biostorage and logistics: With a proprietary sample management system, in-house biostorage capabilities and trusted logistics partners worldwide, we maintain a full chain of custody of your samples at all times and provide 100% traceability.
- Data reliability: Our accreditations and certifications include ISO, CAP and CLIA, demonstrating our commitment to ensuring data reliability for assessing primary and secondary endpoints. Additionally, we fully comply with EMA, FDA and GCLP guidelines throughout our processes.
Contact Us Today to Discuss Your Program
Whether you require flow cytometry to assess potential toxicity in a preclinical study or monitor adverse effects in Phase IV, we can support you. Our technical expertise, advanced instrumentation and rigorous QC processes help ensure your trial milestones are met with accuracy and regulatory compliance. Contact us today to discuss your program or request a custom quote on our flow cytometry services.
