EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of USP 129 testing. USP 129 provides analytical procedures of recombinant therapeutic monoclonal antibodies (mAbs) and subtypes (eg IgG1 and IgG2).
This standard includes validated procedures for chromatographic separation of size variants and purity assessments by capillary sodium dodecyl sulfate (CE–SDS) electrophoresis, and procedures for the analysis of oligosaccharides and sialic acid in mAbs, as well as system suitability criteria.
USP 129 provides specific requirements for the analysis of residual solvents in pharmaceutical products, including the use of appropriate analytical methods, calibration procedures, and acceptance criteria.
The standard also requires pharmaceutical manufacturers to document their analytical procedures and results to demonstrate compliance with the standard.
EUROLAB assists manufacturers with USP 129 test compliance. Our test experts, with professional working mission and principles, offer you the best service and controlled testing process in our laboratories to our manufacturers and suppliers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
