Specialty Testing and Translational Lab Testing
At MLM Medical Labs, our scientists excel in collaboratively designing customized solutions to translate your specific research goals into practical therapeutic applications. We provide expert biomarker identification and validation, comprehensive assay development, tech transfer and validation, regulatory guidance, and project management to advance your novel therapeutics through every phase of the drug discovery and development process.
Our state-of-the-art labs provide a comprehensive range of specialty services to clients worldwide, including flow cytometry, genomics, bioanalysis, and tissue and liquid biopsy analysis.
AVAILABLE SPECIALTY LAB SERVICES
Our specialty testing and translational research team provides operational excellence and support across a broad range of therapeutic areas and unique client needs — from preclinical research and clinical trials to FDA approval.
We have the expertise and instrumentation to measure translational biomarkers like PD-1 and TGF-beta and improve the prediction of your drug efficacy and safety. Additionally, our data management capabilities and harmonized processes enable us to seamlessly integrate data across trial sites and development stages to deliver reliable insights.
Our labs routinely utilize the following platforms and techniques to assess translational biomarkers:
- ELISA (Enzyme-Linked Immunosorbent Assay)
- MSD (Meso Scale Discovery)
- MagPix/Luminex
- RT-qPCR (Reverse Transcription Quantitative Polymerase Chain Reaction)
- Flow Cytometry
Cell-based assays offer several advantages over other types of assays in translational research, including their ability to provide functional insights into drug effects, model disease processes, assess drug toxicity, validate drug targets and facilitate high-throughput screening.
Our scientific team is highly experienced and expertly trained at developing highly customized immune cell-stimulation assays to assess the functional activity of immune cells by stimulating them with relevant antigens, mitogens or other immunostimulatory agents. The response of immune cells — such as T cells, B cells or dendritic cells — is then measured using various readouts, including cytokine production, proliferation, cytotoxicity and activation marker expression.
These types of cell-based assays are particularly important in vaccine development, cancer immunotherapy and autoimmune disease studies.
Read more about our Cell Culture Modeling
Our specialty testing and translational research lab offers comprehensive testing services in all phases of the drug discovery process related to hemostasis and thrombosis. We offer a panel of commercial and proprietary tests as well as three decades of expertise in the area of coagulation.
Our Ph.D.-led team of scientists has worked on hundreds of anticoagulant studies and maintains particular expertise in FX and FXI reversal agents and thrombin generation.
Read more about our Coagulation Testing Services
Consideration of platelet function is essential throughout pharmacologic development. At MLM Medical Labs, we offer a panel of specialty platelet tests, including platelet function analysis and platelet aggregation studies, as well as three decades of expertise in the area of platelet biology to support your preclinical, translational and clinical research needs. Our highly trained research and project management team will work with you to solve your challenges, identify on-site or specialty central lab testing options, or customize methodology and logistics to suit your needs.
Read more about our Specialty Platelet Function Testing
Read more about our Flow Cytometry in Platelet Function Analysis
Our labs in the U.S. and Europe routinely use flow cytometry in research studies across various fields, including immunology, oncology, hematology and infectious diseases.
We have expertise in receptor occupancy studies, wherein flow cytometry enables the characterization of drug-target interactions, pharmacokinetics and pharmacodynamics. This information is valuable for optimizing drug dosing regimens and predicting therapeutic responses.
Our scientists are also experts in immunophenotyping, wherein flow cytometry enables the identification and characterization of immune cell populations based on their surface markers — for example, CD3, CD4 and CD8 for T cells, or CD19 and CD20 for B cells — providing insights into immune cell subsets, activation status, and distribution in health and disease states.
Read more about our Flow Cytometry in Platelet Function Analysis
MLM Medical Labs provides specialized expertise and state-of-the-art technologies that play a critical role in assessing immunogenicity — particularly in the context of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) — providing essential data to clients in all phases of drug development, regulatory decisions and clinical management strategies.
Specifically, our scientists are skilled in helping determine the presence and level of ADAs post-dosing, identifying the specificity of ADAs, assessing the neutralizing activity of ADAs and understanding the kinetics of ADA development, including onset, duration and persistence.
MLM Medical Labs offers specialized and highly customizable assays and expertise to quantify cytokine levels in samples collected evaluating novel immuno-oncology therapies.
Our scientists are highly adept in biomarker discovery and validation by identifying cytokine signatures associated with treatment response, prognosis or adverse events in immuno-oncology therapeutic development studies.
Once the study is assigned to MLM Medical Labs, the study is formally handed over to your assigned project manager and their deputy. From there, the project manager will be your single point of contact and manage all communications within the various departments at MLM. They will remain highly accessible and will lead the team to work diligently to set up your research study, identify potential obstacles, and create custom solutions to ensure your study’s success. We want to emphasize – throughout the course of your study, you will have ease of access to your PM at all times.
As part of the scope of study set-up and management, our experts will provide on-site training in the following areas:
- Instrument Usage
- Sample Collection
- Sample Preparation
- Sample Storage and Shipment
- Real-time Remote Support
WHY TRUST US?
At MLM Medical Labs, we will bring scientific excellence, flexible solutions and personal accountability to your next study through our:
- Expertise: Since 1993, MLM Medical Labs has filled a need in the specialty lab testing industry. Our Ph.D.-level scientists bring a high level of expertise to study solutions in cardiology, oncology, hematology and immuno-oncology.
- Advanced technology: Our comprehensive research services and analytical capabilities are possible with the industry's most advanced technology. We leverage advanced platforms such as MSD and RT-qPCR to deliver high-precision results and adapt efficiently to evolving protocol needs.
- Commitment to quality: MLM Medical Labs is committed to quality in everything we do. We have certifications in ISO, CAP and CLIA and work in full compliance with EMA, FDA and GCLP guidelines. We conduct over 400 internal audits and quality checks yearly to ensure data integrity.
- Customized service: Our team recognizes that specialty and translational lab testing requires custom solutions. We will tailor our services to your trial's protocol, objectives and timeline needs.
- Dedication to accelerating drug development: We understand the complexities of bringing new therapies to market and have designed our services to streamline the journey. From seamless real-time data access for quick decision-making to an agile, collaborative approach, we provide end-to-end support to achieve trial objectives faster.
- Proactive problem-solving: We'll provide a dedicated, experienced project manager as your single point of contact. Your POC will work closely with you to address your needs and keep you informed at every stage. They will also apply their expertise to proactively overcome any challenges that may arise and ensure milestones are met.
CONNECT WITH OUR TEAM TODAY
Our specialty testing and translational research group is ready to mobilize and integrate quickly into your project team to help advance specific concepts, provide solutions to your challenges and increase usable data metrics for your studies.
We encourage you to contact us to explore how our expertise will be a strong added value in navigating your clinical trial program in a successful direction.