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Preclinical PK/PD Services

GemPharmatech's preclinical PK/PD Services deliver end-to-end, customized solutions backed by extensive experience across a broad range of drug modalities — including antibodies, fusion proteins, vaccines, cell & gene therapies, and small molecule drugs. Our platform integrates a full suite of validated technologies: ELISA, MSD, qPCR, flow cytometry, and LC-MS/MS.
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Capabilities
Service Offering

Category

Assays

In vitro ADME

  • Metabolic Stability

  • Cellular Transport Properties

  • Plasma Protein Binding Rate

  • Hepatic Microsomal Metabolic Stability

  • Hepatocyte Metabolic Stability

  • Whole Blood / Plasma Stability

  • CYP Inhibition Phenotyping

  • Caco-2 Permeability

In vivo PK/PD

  • Single-dose PK

  • Multiple-dose PK

  • Disease Model PK

  • Tissue Distribution

  • Drug Absorption

  • Tissue Bioavailability / Tissue Exposure

  • Excretion

  • In Vivo Metabolites

Bioanalysis

  • Large Molecule (Biologics)

  • Small Molecule

  • Cell Therapy

  • Gene Therapy

  • Biomarker

  • Immunogenicity Assessment


Advantages
Advantages

  • Capability to Analyze Multiple Drug Types

- Antibody

-Fusion Protein

-Vaccine

-Cell and Gene Therapy (CGT)

-Small Molecule


  • Accurate In Vivo Sampling

-Accurate blood collection

-Single dose PK with video recording

-Multi-tissue type sampling


  • Robust In Vitro Technical System

-The test system strictly follows ICH M10 guidelines.


  • World’s Leading Mouse Model Repository

-  1000+ Single target/multi-target gene humanized mouse strains

  • 20+ Immune system humanized mouse strains




Case Studies
Case Studies & Validation Data
Monoclonal Antibody PK Analysis
  • Analysis of a CD47 Monoclonal Antibody After Single Intravenous Administration in Female BALB/c-hCD47/hSIRPα Miceicon-arrow-g

    Table 1. The accuracy and precision data of the standard and quality controls reflect technical stability during method validation

    Intra/Inter

    STD1

    STD2

    STD3

    STD4

    STD5

    STD6

    STD7

    QC1

    QC2

    QC3

    QC4

    QC5

    Intra1：%RE

    2.3

    -2.6

    -7.0

    5.4

    6.0

    -4.8

    0.6

    -15.2

    -10.7

    -10.8

    0.1

    6.2

    Intra1：%CV

    0.1

    11.0

    1.5

    1.8

    4.1

    1.6

    2.4

    8.4

    11.1

    2.3

    8.9

    3.2

    Intra2：%RE

    0.3

    -1.6

    3.7

    -1.6

    -0.2

    0.5

    -0.3

    -20.7

    -13.9

    -19.7

    -5.3

    -3.2

    Intra2：%CV

    2.6

    17.6

    1.3

    1.4

    5.1

    0.7

    5.7

    10.7

    10.6

    9.1

    8.1

    9.5

    Intra3：%RE

    -0.8

    5.8

    -9.3

    9.7

    -6.2

    4.0

    -1.7

    -5.9

    -14.0

    -14.6

    4.6

    10.1

    Intra3：%CV

    3.2

    2.0

    10.0

    2.4

    7.8

    3.3

    12.8

    7.3

    4.5

    5.6

    1.5

    5.6

    Intra4：%RE

    -3.1

    -3.8

    -4.7

    -4.4

    16.3

    1.6

    -8.2

    -10.3

    -6.3

    -1.5

    4.5

    -5.0

    Intra4：%CV

    11.2

    3.6

    8.2

    16.3

    6.4

    2.8

    2.4

    8.6

    5.8

    13.1

    10.6

    8.1

    Inter（%RE）

    -2.7

    1.7

    -2.3

    -0.8

    3.0

    1.9

    -3.1

    -11.6

    -13.1

    -12.2

    3.0

    -1.7

    Inter（%CV）

    5.5

    8.2

    6.8

    8.9

    9.8

    4.5

    6.1

    9.8

    9.1

    12.4

    8.0

    9.9

    Inter（%TE）

    8.2

    9.9

    9.2

    9.7

    12.8

    6.4

    9.2

    21.4

    22.1

    24.6

    10.9

    11.6


    Figure 1. Drug Concentrations-Time Curve in BALB/c-hCD47/hSIRPα


    The humanized BALB/c‑hCD47/hSIRPα mice were intravenously administered a single dose of Hu5F9 at 0.5, 1.5, and 5 mg/kg. The drug exhibited nonlinear pharmacokinetic characteristics. Serial blood samples were collected at the indicated time points, with the terminal time point on Day 28. Serum drug concentrations were quantified by ELISA, with a sensitivity of 0.005 μg/mL. Data are shown as mean ± SEM (n=3 mice per group).


    Table 2. PK Parameter Analysis

    Dose

    (mg/kg）

    T1/2

    (Days)

    Tmax

    (h)

    Cmax

     (µg/mL)

    AUC(0-t)

    h*(µg/mL)

    0.5

    2.9

    0.083

    7.455

    66.619

    1.5

    14.0

    0.083

    10.672

    259.522

    5

    23.9

    0.083

    49.145

    1148.069



  • Pharmacokinetic Analysis of Anti-PD1 Monoclonal Antibody After Single Intravenous Administration in Male B6 and B6-hFCRN Miceicon-arrow-g

    Figure 2. Drug Concentrations-Time Curve in B6 and B6-hFCRN

    After a single intravenous injection of pembrolizumab in B6hFcRn mice, the observed half-life was similar to that in humans.


    Table 3. PK Parameter Analysis

    Pembrolizumab

    C57BL/6J

    B6-hFcRnKI

    Human*

    T1/2(Day)

    41.8

    22.5

    25.8


    *:Refers to the population pharmacokinetic parameters of Pembrolizumab in humans; murine data were calculated by curvilinear fitting using time points of 336h-672h.


  • Pharmacokinetic Analysis of YTE-Mutated Monoclonal Antibody After Single Intravenous Administration in Male B6 and B6-hFCRN Miceicon-arrow-g

    Figure 3. Drug Concentrations-Time Curve in B6 and B6-hFCRN


    Pharmacokinetic analysis of the YTE-mutated antibody was performed in B6 and B6-hFcRn mouse models. Following a single administration of human IgG1(YTE) at 10 mg/kg, a extended half-life was observed compared with human IgG1.


    Table 4. PK Parameter Analysis


    T1/2(Day)

    CL(mL/day/kg)

    C57BL/6J

    B6-hFcRnKI

    C57BL/6J

    B6-hFcRnKI

    Human IgG1

    8.4

    2.0

    0.0346

    0.183

    Human IgG1(YTE)

    5.1

    3.7

    0.0420

    0.125


ADC
  • Pharmacokinetic Evaluation of DS8201 After Single Intravenous Administration in Female NCG Tumor-Bearing Mouse Modelicon-arrow-g

    Figure 4. Drug Concentrations-Time Curve in NCG


    DS8201 was administered as a single intravenous dose of 3 mg/kg to tumor‑bearing NCG mice. The concentration–time profiles of ADC and total antibody in the serum of NCG mice were generally consistent, and no free payload was detected in serum. Total antibody and ADC were determined by ELISA with a sensitivity of 1 ng/mL; free payload was measured by LC‑MS/MS with a sensitivity of 0.1 ng/mL. Data are shown as mean ± SEM (n = 3 mice per group).


    Table 5. PK Parameter Analysis


    Total Antibody (Serum)

    ADC (Serum)

    Total Antibody (Tumor)

    ADC (Tumor)

    T1/2(h)

    16.7

    16.0

    45.7

    28.0

    Cmax (nM)

    2328

    2816

    76.9

    63.9

    AUC(0-t) (h*nM)

    50758

    51904

    6370

    4594


Peptide
  • Pharmacokinetic Analysis of Semaglutide After Single Subcutaneous and Intravenous Administration in Male DIO Miceicon-arrow-g

    Figure 5. Drug Concentrations-Time Curve in DIO


    The DIO mice were administered a single dose of semaglutide at 3, 10, and 30 nmol/kg. The drug exhibited linear pharmacokinetic characteristics. Serial blood samples were collected at the indicated time points, with the terminal time point at 72 hours. Plasma drug concentrations were quantified by LC-MS/MS with a sensitivity of 1 ng/mL. Data are shown as mean ± SEM (n = 3 mice per group).


    Table 6. PK Parameter Analysis

    Group

    Dose

    (nmol/kg）

    T1/2

    (h)

    Tmax

    (h)

    Cmax

     (ng/mL)

    AUC(0-t)

    h*(ng/mL)

    G1

    3

    7.16

    4

    69.1

    974

    G2

    10

    7.98

    4

    259

    4892

    G3

    30

    8.50

    4

    857

    15829

    G4

    10

    7.48

    0.25

    915

    5432


Cell Therapeutics
  • Tissue Distribution of HSC Cells in NCG Miceicon-arrow-g

    Figure 6. Tissue distribution of HSC in NCG 


    After administration, major tissues including heart, liver, spleen, lung, kidney, marrow and others were collected at the indicated time points for drug concentration determination. Drug concentrations were quantified by qPCR. The results illustrated the tissue distribution profile of HSC in NCG mice. Relatively high concentrations of the drug were observed in marrow, spleen and lung, indicating an overall favorable tissue distribution property.


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On This Page
  • Capabilities
  • Advantages
  • Case Studies
    Monoclonal Antibody PK Analysis
    ADC
    Peptide
    Cell Therapeutics
  • Expore
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Applications of Genetically Engineered Mouse Models for Hypertrophic Cardiomyopathy Research
Jun 25, 2026
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