PK Bioanalysis

Quality System Certification

        MicroConstants China is the first OECD-GLP compliant bioanalytical service provider in China with 10 LC/MS/MS and 1 MSD system. Our Bioanalytical Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins and peptides using LC/MS/MS, HPLC/UV, and ELISA/MSD detection. We have experience analyzing API and metabolites in diverse biological matrices and can provide bioanalytical support throughout all stages of preclinical and clinical development, including PK/TK studies, BE/BA studies, tissue distribution studies, and drug-drug/drug-food interaction studies. Method validations and GLP/GCP sample bioanalysis are performed in accordance with applicable USFDA, China NMPA and EMA regulations and guidelines. Its PK lab has passed numerous CFDI inspections for many new drug and generics with no project withdraw during the 7.22 clinical trial data self-inspection.
        MicroConstants China shares the same SOPs, LIMS, and quality system as MicroConstants, Inc. in San Diego. Data generated from our laboratory in Beijing has been accepted by relevant regulatory authorities for IND and/or NDA approval. MicroConstants China has no projects withdrawal during the July 22, 2015 CFDA clinical data self-inspection and has passed numerous on-site inspections conducted by CFDI.
MicroConstants China PK lab received following accreditations

Method Development/Validation

        Our method development team in specializes in developing robust methods for the analysis of small molecules, proteins, peptides, and metabolites. We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography/tandem mass spectrometry (LC/MS/MS). Despite the analytical complexity, our scientists approach every compound with creativity, innovation, and years of scientific knowledge, allowing us to uncover solutions to complex bioanalytical challenges.
        Since 1998, MicroConstants has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA methods, including more than 100 non-proprietary assay methods. Our Beijing team work side by side with San Diego team for novel bioanalytical method development for our clients in China.
        MicroConstants performs method validations, method transfers, partial validations, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs. 
        All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation, European Medicines Agency (EMA) and NMPA Guidelines on Bioanalytical Method Validation. And the validation is performed in accordance with USFDA, OECD, MHLW and NMPA Good Laboratory Practice regulations.
        Typically, during bioanalytical method validations, we evaluate the following parameters (not limited to).

PK/BE Bioanalysis

        MicroConstants China is the first OECD-GLP compliant bioanalytical service provider in China. Our Bioanalytical Department specializes in developing and validating robust bioanalytical methods for PK/TK/BE sample analysis of small molecules, proteins and peptides using LC/MS/MS, HPLC/UV, and ELISA/MSD detection. Our PK lab has 10 LC/MS/MS and 1 MSD system to serve our clients’ needs in bioanalysis
        We provide bioanalysis plans for every bioanalytical study and conduct protocol, in-process and reporting phase QA audits for every GLP/GCP project. Method validations and GLP/GCP sample bioanalysis are performed in accordance with applicable USFDA, NMPA and EMA regulations and guidelines. 
        Our PK lab has provided bioanalysis for PK, BE, Bioavailability, and drug-drug interaction studies as well as PK/BE reports for drugs in various stage of clinical trials and has passed numerous CFDI inspections for many new drugs and generics drugs.

ADA and Biomarker Analysis

        Immunogenicity Testing.  Addressing the immunogenicity against large molecule drugs has become critical in assessing their long-term safety. To detect and characterize the level of immunogenicity, we evaluate the anti-drug antibody (ADA) response of biopharmaceutical products using a multi-tiered approach including ADA prescreening, confirmatory assays, and anti-drug activity titers. Established strategies are used to ensure high sensitivity and high drug tolerance in either a direct binding or bridging format with MSD or ELISA, depending on client preference.
        MicroConstants China PK lab can carry out protein drug antidrug antibody (ADA) assay development/transfer, assay validation and sample analysis using MSD based assay following FDA and China NMPA relevant guidelines. 
        Biomarker Analysis. MicroConstants China PK lab can conduct various Immunoassay Method Development, Method Transfers, GLP Validation & Non-GLP Method Qualifications according to project needs. MicroConstants excels at method development using a variety of assay formats including Meso Scale Discovery (MSD) and ELISA/EIA. For novel protein therapeutics, we will design, develop, and validate custom immunoassays using the antibody of your choice, or of commercial origin. If needed, we can also assist with the generation of custom/novel antibodies against your protein therapeutic. For assays developed in non-GLP laboratories, we can transfer and validate them at MicroConstants under GLP regulations. MicroConstants also offers immunoassay method qualifications, an assay characterization procedure with less rigor than the full GLP validation protocol, but with less expense for those situations where a fit-for-purpose approach would be optimal.