Our broad and growing portfolio currently contains over 300 validated assays for various parameters. The diverse set of analytical methods includes chromatogenic assays, enzyme assays, ELISAs, RIAs, ECLIAs and HPLC protocols. We have successfully implemented multiplex immunoassays and cell-based assays in recent years.
The assays used for the determination of pharmakokinetic or pharmacodynamic endpoints are all validated according to FDA and EMA guidelines for bioanalytical method validation. In general, method validation studies can be completed within approximately three months.
If no commercial assay is available, the analytics can be still be prepared and performed. MLM has an excellent track record for de novo development of assays for special parameters. Based on literature data or client research results, we will design and manufacture the assay and perform FDA- and EMA-compliant validation.