Large Molecule Bioanalysis,Bioanalysis, bioanalytics, Bioanalytical Services |Medicilon Inc-Shanghai Medicilon Inc.

Preclinical research

Pharmacology & Pharmacodynamics Study

Tumor Models Digestive System Disease Models Endocrine & Metabolic Disease Models Inflammatory & Immune Diseases Models Neural System Disease Models Other Disease Models
Drug Safety Evaluation

Pharmacology & Toxicology Study Safety Pharmacology Histopathological Study Clinicopathological Study Drug Safety Evaluation Basic Information Toxicokinetics
Pharmacokinetics

In Vitro Pharmacokinetic Assays In Vivo Pharmacokinetic Assays
Bioanalysis

Macromolecular Drugs Bioanalysis Micromolecular Drugs Bioanalysis
IND Filings

HomeservicesPreclinical researchBioanalysisMacromolecular Drugs Bioanalysis

Macromolecular Drugs Bioanalysis

Our Bioanalysis Department can provide bioanalysis of macromolecular drugs in accordance with standards of FDA/NMPa GLP to support the selection and development, preclinical and clinical research of protein drugs, antibody drugs, vaccines and biomarkers.

Download

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

Relevant articles

Macromolecular Drugs Bioanalysis Micromolecular Drugs Bioanalysis