MLM Specialty Testing and Translational Services
ACCELERATING INNOVATION THROUGH CUSTOMIZED SOLUTIONS
At MLM, 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, from preclinical research and clinical trials to FDA approval.
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.
MLM’s specialty testing and translational research team has the capability to provide operational excellence and support across a broad range of therapeutic areas and unique client needs:
MLM Medical Labs assay development services offer a combination of exceptional scientific laboratory expertise with state-of-the-art instrumentation to design, optimize, evaluate, qualify, verify and validate a custom or commercially available assay that improves the prediction of your candidate’s drug efficacy and safety. Our experienced team of Ph.D. level scientists and subject matter experts has successfully developed or validated over 1000 assays in the last five years.
Our labs routinely utilize the following platforms and techniques to assess target biomarkers:
- ELISA (Enzyme-Linked Immunosorbent Assay)
- MSD (Meso Scale Discovery)
- MagPix/Luminex
- RT-qPCR (Reverse Transcription Quantitative Polymerase Chain Reaction)
- Flow Cytometry
- Learn more about our Assay Development and Biomarker Services
Search our menu of over 1,000 validated and customizable assays HERE.
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 particularly 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, in the field of cancer immunotherapy and autoimmune disease studies.
- Read more about our Cell Culture Modeling
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 are highly regarded for our 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 (e.g., CD3, CD4, CD8 for T cells; CD19, 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
At MLM, specialized expertise and state-of-the-art technologies plays 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 particularly skilled in helping determine the presence and level of ADAs post dosing, identifying the specificity of ADAs, assessing the neutralizing activity of ADA’s, and understanding the kinetics of ADA development, including onset, duration, and persistence.
MLM offers specialized and highly customizable assays and expertise to quantify cytokine levels in samples collected during preclinical, translational, and clinical trials evaluating novel immune 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 immune 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
Consideration of platelet function is essential throughout pharmacologic development. At MLM, we offer a panel of specialty platelet tests 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 onsite or specialty central lab testing options, or customize methodology and logistics, if necessary, to suit your needs.
- Read more about our Specialty Platelet Function Testing
- Read more about our Flow Cytometry in Platelet Function Analysis
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 PhD-led team of scientists has worked on hundreds of anticoagulant studies and maintain a particular expertise in FX and FXI reversal agents and thrombin generation.
- Read more about our Coagulation Testing Services
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 to navigate your clinical trial program in a successful direction.