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CRO Services

Drug Development Expertise Empowering Research Services for Biologics

Pharmacokinetics and Pharmacodynamics (PK/PD)

One-Stop PK/PD Studies for Preclinical Research

At WuXi Biologics, our PK/PD integrated platform provides a one-stop waiting-free solution for multi-species in vivo studies and dose-concentration-response evaluation, covering protein generation from sequence, zero leading time of animals (NHP and murine) scheduling, in vivo treatment & sampling, and ex vivo bioanalysis.

 

This platform is designed to optimize the distribution, metabolism, and elimination of preclinical candidates, enabling lead characterization and screening with optimized half-life and stable clearance. Our flexible, integrated approach supports all large molecules, including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), and antibody-drug conjugates (ADCs), offering tailored solutions to meet diverse in vivo pharmacology requirements.

 

Key Features of PK/PD Services:

  • Fast turnaround PK/PD evaluation using non-human primate (NHP), murine, canine, and swine
  • Customized PK assays for various therapeutic modalities, utilizing ELISA, MSD, LC-MS, and HTRF platforms
  • Reliable, cost-effective hFcRn mouse model for Fc engineering assessment
  • High-accuracy and in-depth data analysis, backed by scientists with strong expertise of drug discovery

Customized pharmacokinetics (PK) and pharmacodynamics (PD) analysis for dose-concentration-response evaluation.

Pharmacokinetics (PK) Service Details:

Service Item

Description

Turnaround Time

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Mouse PK

Sample requirements:

1. Protein amount: BW (mouse/25 g; rat/250 g; cyno/5 kg) × animal numbers × 150%

2. Protein purity: >98%

3. Endotoxin level: <2 EU/mg

4. Protein concentration (mg/mL): > dosing level (mg/kg)/10 (mL/kg)

 

Deliverables:

1. Serum/plasma concentration of total IgG, total Ab, total ADC, or free payload

2. PK parameters including t1/2, clearance, AUC, etc.

6-7 weeks

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Rat PK

6-7 weeks

NHP PK

7-8 weeks

Canine or Swine PK

7-8 weeks

 

 

Pharmacodynamics (PD) Service Details:

Service Item

Description

Turnaround Time

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Immunophenotype

Sample requirements:

1. Protein amount: BW (mouse/25 g; rat/250 g; cyno/5 kg) × animal numbers × 150%

2. Protein purity: >98%

3. Endotoxin level: <2 EU/mg

4. Protein concentration (mg/mL): > dosing level (mg/kg)/10 (mL/kg)

 

Deliverables:

1. Immunophenotype:

     % of T/B/NK/Myeloid cells at different timepoints

     % of targeted cells at different timepoints (specify biomarkers)

2. Receptor occupancy:

     % of occupied targeted cells at different timepoints

 

 

5-6 weeks

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Receptor Occupancy

Case Study #1: Development of Customized ELISA Assays for In Vivo PK Profiling of IgG-Like Molecules

In this case study, we developed customized ELISA methods to evaluate the integrity of bispecific antibodies (bsAbs) and antibody-drug conjugates (ADCs). These assays were specifically designed to assess the structural stability of various therapeutic drug candidates over time.

Case study on customized ELISA methods to evaluate the integrity and structural stability of bispecific antibodies and antibody-drug conjugates for in vivo PK profiling over time.

Figure 1: (A) The PK curves obtained for Fab-Fc (total antibody) and Fc-Fc (total IgG) confirmed the intact structure of the bispecific antibody in vivo. (B) A discrepancy in the AUC between the drug-Fc and Fc-Fc curves indicated partial disassembly of the linker payload in the ADC molecule, highlighting instability issues that require further investigation.

Case Study #2: Established hFcRn Mouse Model for Early-Stage Fc Engineering Assessment

In this case study, we utilized a well-established hFcRn mouse model to simulate the in vivo PK profiles of both human and NHPs to evaluate Fc engineering.

Case study on using a hFcRn mouse model to simulate in vivo PK profiles of human and NHPs for early-stage Fc engineering assessment.

Figure 1: (A) The antibody concentration curve demonstrated improved PK profiles in the Fc-engineered molecule compared to wild-type counterpart when tested in hFcRn mice. (B) A strong linear correlation of half-life (t1/2) between hFcRn mice and NHP models further validated the hFcRn mouse model as a reliable tool for screening Fc-engineered candidates.

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Frequently Asked Questions for PK/PD Studies

Q: For PK in NHP models, how do you deal with the interference of NHP antibodies?

A: For PK studies, we use a highly specific ELISA kit that binds only to human Fc. There is no interference or cross-reactivity with NHP IgG, so the assay provides a clean background.

Q: Is it appropriate to use hFcRn transgenic mice for T cell engagers that do not have engineered Fc regions?

A: Human FcRn mice express only the hFcRn receptor. Even without Fc engineering, they provide better PK simulation than wild-type mice and offer more consistent PK profiles for human-relevant predictions. However, they are suitable only for PK studies, not efficacy studies, as the T cells or other targets are not humanized.

Q: Are PK results from hFcRn transgenic mice consistent with those from NHP studies?

A: Yes. PK data from hFcRn mice generally correlate well with NHP results. Our studies show strong linear correlation (R² > 0.95) between the two models, supporting the use of hFcRn mice as a predictive tool for human PK.

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