Macromolecular Drugs Bioanalysis

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Service

• Development and methodological verification of macromolecular bioanalysis methods
  Develop, transfer, optimize and verify immunoassay methods for the determination of drug concentration in biological matrixDevelop and optimize proven 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
• Biological markers
  Inflammation markersOrthotopic markersMetabolic disease markersCardiovascular disease markersBone markers
• Vaccine analysis
  Detection of monovalent and multivalent vaccinesDetection of multi-serotype antibodiesHigh-throughput automation technology
• Immunogenicity tests
  Selection testsDeterministic testsTiter determination

Highlights

• Comprehensive information management, and 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 researches of frontier 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 different 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

Instruments

• MSD Sector Imager 6000 Luminex Bio-Plex 200Gyrolab xPloreMoleculeDevices M2/M4/M5 reader  UV 2600 spectrometer BioTek ELx405 Select Hamilton workstation  Applied Biosystems 7500 Real-Time PCR SystemThermo NanoDropPerkin Elmer EnVision Plate ReaderBiacore 8KThermo KingFisher FlexCovaris E220 AFA

Relevant laboratories

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