ADC ADME Characterization

ADC ADME Characterization

BOC Sciences is a leading provider of ADME characterization services, including in vitro and in vivo assays to assess the ADME properties of potential drug candidates. Whether you're dealing with small molecules, biologics, or antibody-drug conjugates (ADCs), our top-tier ADME characterization services are engineered to deliver unparalleled insights into the intricate pharmacological workings of your compounds.

What is ADME Characterization?

ADC ADME Characterization

The incisive and multifaceted process of ADME characterization has emerged as a veritable cornerstone in the field of drug development. Rife with intricacies and complexities, the exhaustive analysis of absorption, distribution, metabolism, and excretion has become an indispensable component in the pursuit of efficacious and safe drug candidates. Through its comprehensive and meticulous evaluation of the pharmacokinetic properties of potential drugs, ADME analysis not only facilitates an acute prediction of their behavior in the human body but also serves as a pivotal instrument in determining their potential toxicity and efficacy. By delivering invaluable insights into the interplay between drugs and the complex physiology of the human body, ADME analysis has entrenched itself as a pivotal tool in the ever-evolving landscape of drug development and discovery.

Application of ADME Characterization in ADC

The intricate and multifarious process of ADME characterization has emerged as an indispensable cog in the ever-expanding realm of ADC development. With the dynamic interplay between the monoclonal antibody, the linker, and the cytotoxic payload, the ADME properties of ADCs become a convoluted web of complexities that requires a comprehensive and painstaking evaluation of each component and their collective interactions. Given the manifold implications of the ADME properties of each constituent, the meticulous assessment of their individual and combined effects on the overall pharmacokinetics of the drug becomes a pivotal determinant in the realization of safe and effective drug candidates. Therefore, the evaluation of the ADME properties of each component and their holistic influence has become a critical imperative in the realm of ADC development, propelling the field ever-forward with groundbreaking insights and unparalleled discoveries.

Our ADME Screening Workflow

ADME Characterization Services for ADC

BOC Sciences provides an extensive array of cutting-edge ADME characterization services for ADC, consisting of both in vitro and in vivo assays that meticulously scrutinize the drug's multifaceted absorption, distribution, metabolism, and excretion properties. Our discerning employment of state-of-the-art equipment and techniques enables us to furnish you with an unparalleled level of precise and dependable data concerning your drug's intricate ADME traits. Among our expansive portfolio of ADME characterization services, we are proud to offer you the following exceptional services:

In Vitro Assays for Drug Metabolism

BOC Sciences provides a vast array of in vitro assays designed to evaluate the drug's metabolism in a comprehensive manner. These assays include the cytochrome P450 (CYP) inhibition assays, CYP induction assays, and metabolic stability assays, which are all essential in the identification of potential drug-drug interactions and the accurate prediction of the drug's clearance.

In Vivo Assays for Drug Pharmacokinetics

The extensive in vivo assays provided by BOC Sciences help researchers fully understand the pharmacokinetics of drug development. These cutting-edge assays, ranging from biodistribution studies to clearance studies and pharmacokinetic modeling, are essential in determining the drug's intricate details such as half-life, bioavailability, and distribution in various organs and tissues.

In Vitro and In Vivo Assays for Drug Toxicity

BOC Sciences is proud to present our diverse range of cutting-edge assays aimed at assessing the drug's toxicity in both in vitro and in vivo settings. These assays, including the cell viability assays, genotoxicity assays, and acute toxicity studies, are all essential in comprehensively evaluating the potential risks and hazards associated with drug use. In addition, these assays help to identify potential safety concerns and predict the drug's maximum tolerated dose.

In Vitro Assays for Drug-Drug Interactions

BOC Sciences offers a range of in vitro assays to assess the drug's potential for drug-drug interactions, including CYP inhibition assays, transporter inhibition assays, and plasma protein binding assays. These assays help to identify potential drug-drug interactions and predict the drug's clearance.

Our ADC Analytical Characterization Equipments

ADC ADME Characterization

  • High-performance liquid chromatography (HPLC) for purity analysis and quantification of drug-to-antibody ratio (DAR)
  • Mass spectrometry (MS) for molecular weight determination and identification of drug conjugation site
  • Gel electrophoresis for protein separation and characterization
  • UV-Vis spectrophotometry for determination of drug loading and concentration
  • Dynamic light scattering (DLS) for particle size analysis and stability assessment
  • Isothermal titration calorimetry (ITC) for determination of binding affinity between antibody and drug
  • Circular dichroism (CD) spectroscopy for secondary structure analysis of protein conjugates
  • Fluorescence spectroscopy for monitoring drug release kinetics and drug-target interaction.

Our ADC Quality Verification Capabilities

ADC ADME Characterization

  • Analytical method development and validation
  • Quality control testing
  • Microbiological testing:
  • Environmental monitoring
  • Stability testing
  • Quality management system
  • Regulatory compliance

Our cGMP Manufacturing Capabilities

ADCs can be manufactured under cGMP standards by BOC Sciences for use in commercial and preclinical investigations. We adhere to cGMP requirements and standards by using a thorough quality management system. To guarantee the security, potency, and purity of the finished product, our organization has established standard operating procedures (SOPs) for all manufacturing stages and performs stringent quality control testing. The business is aware of the regulatory needs of many nations and areas, including the FDA, EMA, and PMDA. We can offer ADC cGMP manufacturing services at a range of scales, from modest quantities for clinical trials to massive quantities for commercial production.

* Only for research. Not suitable for any diagnostic or therapeutic use.
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