Millipore BioPharma Services

Overview

Millipore's BioPharma Services is a leading CRO specializing in ligand binding assay (immunoassay) support for pharmacokinetic assessments of biotherapeutics, determination and development of novel biomarkers, detection of anti-drug antibodies (immunogenicity testing), and PK/TK/PD analysis of resultant data. Projects are performed with GLP compliance and often include custom reagent development.

Our Regulatory Compliant Laboratory (RCL) is a CRO leader in the development, validation and application of ligand binding assays enabling development of biopharmaceuticals and translational biomarker applications. The 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 Quality Assurance unit.

Standards & Methodologies

US FDA Good Laboratory Practices, GLP, CLIA, USP, GMP, OECD

Qualifications, Certifications, Accreditations & Licenses

US FDA Good Laboratory Practices, GLP, CLIA, OECD