Inquiry Basket
Loading ......
Creative Diagnostics provides you with highly advanced Pharmacokinetics (PK) Assays for Antibody-Drug Conjugates (ADCs) to monitor in real time and with high accuracy the absorption, distribution, metabolism, and excretion (ADME) of a drug. Our PK assay solutions offer you the best of latest analytical platforms and validated bioanalytical assays for accurate, sensitive, reproducible, and stable measurement of ADC PK. They can be used for a wide range of applications such as ADC development, therapeutic monitoring, preclinical-to-clinical translation, etc. and accelerate PK profiling, optimize dosing strategies, and aid in regulatory submissions in drug development and biomedical research.
Molecular Devices SpectraMax® iD5
Waters ACQUITY UPLC I-Class PLUS
Cytiva Biacore T200
Creative Diagnostics has experience in PK Assays for Antibody-Drug Conjugates (ADCs). We are able to offer thorough Pharmacokinetics (PK) Assays for Antibody-Drug Conjugates (ADCs) to facilitate the characterization of the disposition and in vivo properties of ADCs. We have extensive experience in bioanalytical method development, sensitive detection technology, and assay optimization to provide custom PK assay platforms for your research. Our robust systems allow for the quantitation of total antibody, conjugated drug, and free drug with high sensitivity, specificity, and reproducibility to support real-time pharmacokinetic profiling, bioavailability studies and in vivo stability analysis to expedite ADC development and translation into the clinic. We provide:
To meet the need for accurate and reliable analysis in the pharmacokinetic studies of antibody-drug conjugates (ADCs), we provide comprehensive Pharmacokinetics (PK) Assays for ADCs services. Through the use of modern bioanalytical platforms and the most sensitive detection instruments available, we are able to precisely quantify and dynamically track ADCs and their components (total antibody, conjugated drug, free drug). We provide optimized sample processing procedures, strict experimental validation and a range of analysis methods (LC-MS/MS, immunoassays, high performance liquid chromatography), to provide the best sensitivity, specificity, and biological significance of data. Our platform can be applied to the pharmacokinetic evaluation of ADCs, dose selection, and preclinical and clinical study support. Our strict quality control system and deep technical experience have brought high reproducibility, stability, and data consistency to each project. Our core services include:
Determine total antibody, conjugate (payload), and free drug in ADCs, with comprehensive in vivo PK profiles.
We offer optimal extraction and cleanup methods for plasma, serum, and tissue samples, providing efficient recovery and stability of the analyte of interest.
Utilize highly sensitive liquid chromatography-mass spectrometry and enzyme-linked immunosorbent assay (ELISA) technologies to detect and distinguish target components.
Pharmacokinetic parameters including half-life (t½), clearance (CL), volume of distribution (Vd), Cmax, and AUC are calculated.
Monitor the in vivo stability and drug release behavior of ADCs, providing a basis for drug design and optimization.
Design PK plans tailored to project needs and develop customized analytical methods to meet preclinical and clinical research standards.
We implement GLP standards to ensure data accuracy and reliability, supporting drug registration and regulatory submissions.
We provide detailed technical consulting services and data analysis and interpretation to help clients understand PK characteristics and optimize subsequent research and development strategies.
Develop analytical plans, collect and prepare samples, and ensure quality.
Establish and validate assay methods to ensure sensitivity and accuracy.
Precisely quantify target compounds using advanced technologies.
Rigorously monitor experiments to ensure data reliability.
Analyze results, generate reports, and provide support.
This LC-MS/MS trace shows the quantitation of the conjugated drug component of an ADC in a plasma sample. The x-axis is retention time (min) and the y-axis is signal intensity (intensity). A clear, symmetrical main peak appears at 2.5 minutes, demonstrating the successful separation and detection of the target drug component in a complex biological matrix. This result demonstrates the high sensitivity and specificity of the analytical method, supporting multicomponent quantification and pharmacokinetic parameter assessment of total antibody, conjugated drug, and free drug, providing reliable data for in vivo behavioral studies and preclinical development of ADC drugs.
Because ADCs are complex structures, PK analysis helps us understand how the antibody and drug behave in vivo, ensuring efficacy and safety.
Of course. Our technology can accurately measure all key components of the ADC simultaneously, providing comprehensive pharmacokinetic data.
We primarily use LC-MS/MS and immunoassays, a combination of which offers both sensitivity and precision.
We typically provide a detailed report within a short time after sample analysis, including all key PK parameters and data interpretation.
Of course, we can tailor the experimental design to your specific needs to ensure compliance with R&D and regulatory requirements.
To use our PK analysis of ADC services, please contact Creative Diagnostics, your expert immunology service provider. From research-scale PK analysis of ADC services to scale-up, our team is ready to support your R&D innovation.
Loading ......
