The analysis of samples is our core competence. MLM offers all the assays required for general health assessment of study subjects. These so-called safety samples are used for blood counts, coagulation, clinical chemistry, serology and urinalysis.
We're open 365 days a year, and safety sample analysis is performed on the day of receipt of the sample, with the results reported the same day. Reports are sent via email and can also be viewed through our portal mlm onlineTM.
We have over 300 validated assays for pharmacodynamic assessments, including detection of simple molecules like glucose and creatinine and complex methods like multiplex assessment of proinflammatory cytokines. All methods are validated in compliance with EMA and FDA guidelines for bioanalytical method validation.
The analysis of pharmacodynamic parameters is generally conducted in campaigns, ensuring that all samples from all time points for a given patient are analyzed in the same campaign. However, on request, we can also analyze such samples upon delivery.
MLM also offers pharmacokinetic sample analyses, such as measurement of drug concentrations in plasma, serum or urine over time. Recombinant proteins used as biopharmaceutical drug compounds can be analysed with immunological methods, such as electrochemiluminescense immunoassays (ECLIA), radio immunoassays (RIA) or enzyme linked immuno sorbent assays (ELISA).
MLM has gathered extensive experience in pharmakokinetic analysis of biopharmaceuticals and the compilation of data into corresponding bioanalytical reports.
For the bioanalysis of small molecule drug compounds via LC-MS/MS, we have a qualified GLP-compliant partner laboratory within driving distance of the MLM site.
Other analytical services include:
- Assessment of anti-drug-antibodies for marketed and new drugs using commercial assays and in-house developed and validated assays
- Testing of the potency of anti-TNF-alpha antibodies such as infliximab or humira using the iLiteTM reporter gene cells
- Next-generation sequencing (NGS) assessment of the microbiome using stool samples
Our portfolio is always growing as we adopt and validate new methods. If you need a specialty analysis not yet presented in our portfolio, let us know.