Preclinical Overview
Preclinical
Drug Development Services
MLM Medical Labs preclinical contract research capabilities are well established in the field of in vitro assays ranging from cell-based mechanism of action studies (MoA) and compound screening to well-characterized in vivo models for pharmacology and efficacy assessments, which are supplemented by ex vivo services.
Our laboratories offer a range of established models (60+ models in our ever-growing portfolio) including those for many inflammatory diseases relating to dermal, oncologic, respiratory, metabolic and other conditions.
Integrating our preclinical models and in-house biomarker development and validation services allows us to combine models with necessary readouts to produce the highest degree of value and clinical relevance for your research in one lab, without the need to coordinate across multiple vendors.
Preclinical Services
MLM’s comprehensive suite of Preclinical Research Services is meticulously tailored to meet your specific research needs. These services span, cell culture modeling, in vivo disease modeling, PK/PD assessments, safety evaluations, and dose studies.
Beginning with the earliest stages of research, cell culture services offer a versatile and controlled environment to explore drug responses and mechanisms of action in vitro. Our experienced team customizes cell culture protocols to mimic physiological conditions, ensuring the relevance and reliability of your experimental outcomes.
Adding to the breadth of MLM’s research capabilities, our preclinical in vivo disease model portfolio includes models in multiple disease areas within the immunology space. To complement in vivo models, a complete suite of biomarker service capabilities spans across various platforms, including ELISA, Multiplex, Flow Cytometry, and qPCR. Additionally, our fully equipped histology suite accommodates general staining as well as specialty IHC, IF, and ISH staining.
By offering ex vivo services onsite, MLM alleviates the need for multiple vendors, ensuring sample integrity remains intact and providing added convenience.
Partner with us to navigate the intricacies of preclinical development and confidently propel your drug development initiatives forward.
Accredited, Compliant, and Quality-Driven
At MLM Medical Labs we believe that quality and attention to detail are critical aspects of scientific research. Sponsors have come to rely on us to with their preclinical studies both in the design and implentation of the studies and the quality and consistency in the execution and data delivery.
Our dedication to quality is evident through our adherence to Good Laboratory Practice (GLP) standards. This encompasses meticulous implementation of Standard Operating Procedures (SOP), precise sample handling and inventory management, vigilant monitoring of laboratories and equipment, thorough maintenance/calibration procedures, and comprehensive record storage and backup. Our commitment extends to a robust Quality Assurance department/program.
Animal Welfare Commitment
At MLM Medical Labs, we prioritize the well-being of our animal counterparts, exemplified by our AAALAC accreditation in St. Paul. Our Institutional Animal Care and Use Ethical Committee (IACUC) meticulously reviews and approves all protocols, ensuring ethical practices in research. For sponsors engaged in NIH-funded projects, our readily prepared Office of Laboratory Animal Welfare (OLAW) Assurances are tailored to meet the highest standards. If you are involved in an NIH-funded project, contact us, and we’ll promptly submit the Assurance on your behalf. MLM Medical Labs stands at the forefront of scientific excellence and unwavering commitment to animal welfare.
Preclinical Services FAQ
MLM Medical Labs has extensive offerings for efficacy studies in disease models in the inflammatory/immunology space. Additionally, MLM can assist with dose range finding, toxicology, and PK/PD studies.
We understand that each therapeutic treatment is unique which is why we customize our approach for every study. In addition to our standard disease models, we can develop new preclinical models tailored to meet our clients’ specific research needs.
We provide comprehensive support for preclinical drug development, offering scientific, and strategic guidance. This includes services such as cytokine assessment, pathology, detailed reporting, and secure archiving of preclinical research samples. Moreover, our in-house capability allows us to perform the majority of ex vivo assessments on site, minimizing the need for multiple vendors and ensuring high sample quality, which is imperative for accurate data readouts.
MLM has experience with bioanalysis catering to various types of compounds and drugs, including small and large molecules, biologics, cell-based therapies, natural-based compounds, and combination products. NCEs, Biologics-Experience in handling small molecules, biologics, cell-based therapies,
natural-based compounds, genomic test items (siRNA, RNAi, mRNA, DNA based) and combination
products.
MLM Medical Labs‘ preclinical department stands out due to its unwavering commitment to a tailored approach with quality excellence. Each study, regardless of GLP status, upholds the highest quality standards. With an impressive study initiation time post-SOW signature, MLM outpaces industry norms, delivering faster results.
This tailored and agile approach of MLM is underscored by an experienced preclinical team, proficiency in developing new models, and tailored solutions to meet diverse research needs.
Upon submitting your preclinical inquiry, you‘ll be paired with a dedicated business development team member for personalized support. Our early involvement of scientists ensures your research objectives are thoroughly understood. After signing the Statement of Work, your business development representative will transition to background support, while your study director manages protocol review and submission to IACUC. The business development representative and the study director maintain close contact to ensure a seamless process, providing the attention and expertise your research deserves.
Yes!
MLM Medical Labs designs preclinical studies, keeping in mind the clinical implications such as pathogenesis, and emerging therapies. Our expertise extends to assisting our partners with selecting optimal models and conducting ex vivo analyses, ensuring an appropriate transition from preclinical research to clinical applications.
We have central and specialty lab facilities with extensive service offerings in Europe and the US to support your drug development from preclinical through Phase III.