As a leading contract research organization (CRO), EMD Millipore’s Regulatory Compliant Laboratory (RCL) designs, develops, optimizes, and validates analytical techniques for pharmacokinetic assessments of biotherapeutics, determination of novel biomarkers, and detection of anti-drug antibodies (immunogenicity testing). These activities comply with regulatory expectations (CLIA, GLP, OECD), including computer validation (21 CFR Part 11) and oversight by our QA unit.
For specific information about the services listed below, visit BioPharma Services:
- Immunogenicity Testing Services
- 'Fit for Purpose' Biomarker Assay Validation Services
- Pharmacokinetic (PK) Assessments of Biopharmaceuticals
- Pharmacokinetic (PK) Data Services
To learn more about EMD Millipore's Drug Discovery & Development, visit Drug Discovery & Development.