Clinical Trial Services for Regulatory Environments
Cell Therapy Development at MLM Medical Labs
MLM Medical Labs is a GLP-certified, CLIA-, CAP- and ISO15189 accredited laboratory dedicated exclusively to clinical trials. MLM services include a full range of analytics: standard safety profiles, analyses of biomarkers, drug compounds, metabolites and molecular diagnostic parameters, and GCP-compliant lab work.
The lab is designed and equipped to ensure robust, valid results and optimized turnaround time. A highly skilled team with extensive clinical lab experience supports 160-170 clinical studies, Phase I-IV, at any given time.
Clinical trials continue to become increasingly complex and the spectrum of analytical methods has expanded significantly. Personalized medicine is the R&D focus for many so far unmet medical needs, leading to dramatic increases in the number of cell-based therapeutics being tested in clinical trials. As a state-of-the-art cell culture lab, MLM is committed to providing high quality solutions that meet demanding regulatory requirements.
“Every single clinical trial has specific requirements and often demands new analytical protocols or the adaption of existing ones. It is our aspiration to deliver high quality customized lab solutions in compliance with clinical trial regulations to contribute to the development of novel therapeutics. It is an honor and challenge at the same time to work in an environment with cutting-edge scientific approaches.”
Professor Dr. Stephan Wnendt, CEO
“The NucleoCounter® NC-200™ cell counter is an integral part of our cell culture lab, especially in the field of PBMC isolation. New protocols can easily be established and our lab technicians can be trained very efficiently. 21 CFR Part 11-compliant protocols document all measurements and secure replicable measurements.
We use the NC-200™ to provide our clients with high quality samples with precise cell numbers as a preparational step for further analysis in their clinical trials.”
Learn more about MLM Medical Labs.