Immunogenicity of biotechnological drugs
Study of immunogenicity parameters of biotechnological medicinal products.
The study is conducted by identifying and confirming the presence of binding antibodies to the drug in samples using enzyme immunoassay methods, as well as identifying samples with antibodies that have neutralizing activity using enzyme immunoassay methods or cellular techniques validated in accordance with the current regulatory requirements of the EAEU.
To implement immunogenicity studies, it is possible to develop our own test systems or use commercially available reagent kits.
As part of pharmacokinetic studies, biosamples are stored at a temperature not exceeding -65 °C for two months after completion of the study, followed by disposal.
9
chromatograph mass spectrometers
that allow for high-precision determination of low-molecular compounds in biological samples
500+
research
on bioequivalence and pharmacokinetics of medicinal products implemented by the laboratory
ISO 9001
Management System
is certified for compliance with the standard of Good Laboratory Practice (GLP) principles
Other services within the scope of the direction clinical studies
01
Pharmacokinetics of small molecules
02
Pharmacokinetics of biotechnological drugs
03
Pharmacodynamics of biotechnological drugs
04
Central laboratory (safety and efficacy parameters)
05
Statistical processing (BE, I, II, III phases)
06
Comparative Dissolution Kinetics Test (CDK)
07
Biowaiver
08
Preparation of laboratory kits for conducting clinical trials
09
Provision of specific reagents, consumables