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 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
• 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

Feature Platform

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  Nucleic Acid Drugs Bioanalysis

  Nucleic Acid Drugs Bioanalysis

  PK/TK AnalysisImmunogenicity analysisPD or TOX-related cytokines and biomarkers (Cytokine & Biomarker)
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  Metabolite Identification

  Metabolite Identification

  In vitro incubation metabolite identificationReactive metabolite identificationIn vivo metabolite identification
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  ADC Immunogenicity

  ADC Immunogenicity

  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

Instruments

• MSD Sector Imager 6000/SQ120Molecule Devices M4/M5e/i3X Plate ReaderBioTek ELx405 Plate WasherGyrolab xPloreCytoFlex FACSCTL ELISPOTQIAcuity One 5 Plex ddPCRNanodrop NP-80Vi-CELL XR cell CounterPE Envision plate readerLuminexBiacore 8KABI7500 qPCR

FAQ

• Advantages and Disadvantages of Ligand Binding Assay

  LBA：Main Advantages 

    Sensitivity: High 

    Quantitation: Cost effective and Fast

  LBA：Main Disadvantages 

    Requires a good reagent (time) 

    Dilutions, nonlinearity, matrix effects, hook effects, etc.

Relevant laboratories

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Relevant articles