Our Bioanalysis Department can provide analysis of macromolecular drugs in accordance with FDA and NMPA GLP standards to support the selection and development, of small molecule drugs, antibody drugs, vaccines and biomarkers.
Development and methodological verification of macromolecular bioanalysis methods
Develop, transfer, optimize and verify immunoassay methods for the determination of drug concentration in a biological matrixDevelop and optimize immunoassay methods for drugs such as adalimumab, bevacizumab, trastuzumab, pertuzumab and antibody drug conjugateQuickly and efficiently complete methodological verification to support the needs of potential projects
Analysis of proteins, antibodies, polypeptides and drugs
Global clinical and preclinical trialsPharmacokinetics, toxicity and immunogenicity testsBioequivalence experiments
Immunogenicity is a key parameter when evaluating biologic therapeutics. It could increase the potential risk of adverse effects and reduced ADC efficacy. Medicilon fully understands the complexity of ADA evaluation and offers our clients with comprehensive immunogenicity assays.
Highlights
Comprehensive information management, a perfect sample management chain and experimental data processing, tracking and storage chain by using the verified laboratory information management system (Watson LIMS 7.2);Verified WinNonlin software for data analysis;Data accepted by FDA and NMPA, and biotechnology drug analysis services that fully meet FDA/NMPA/OECD GLP requirements;Independent micromolecule bioanalysis platform and bio-tech-based drug analysis platform;All-round and multifunctional technology platforms including SpectraMaxM4/M5/i3x, MSD, Luminex, Biacore 8K, Envision, Gyrolab and ABI7500 qPCR;Flexible employment of ELISA, ECL, IP, Co-IP, qPCR, FACS, Elspot, enzymology and other methods to support the early development, preclinical and clinical assessment of biopharmaceuticals, including proteins, antibodies (monoclonal antibodies, bi- or multi-specific antibodies and antibody fragments), ADCs, polypeptides, nucleic acids, vaccines and cell gene therapy drugs.Development and verification of analytical methods for diverse targets such as CD-4, CTI-4, PD-1, PD-L1 and T-DM1 analog ADC to support the analysis of PK/TK/Total ADA (NAB)/biomarker/cytokine.
Strength
Development of immunoassay and verification of methodologyAnalysis of protein, antibody, ADC, polypeptide drugs, vaccines and cell and gene therapy productsSelection and analysis of biomarkers and detection of cytokinesImmunogenicity test of anti-drug antibody (ADA)Determination of vaccinesBiological analysis of clinical samplesSupport for pharmacokinetics (PK), toxicokinetics (TK), tissue distribution test and IND filings
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