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Pharmacokinetics(PK) Characterization

Creative Biolabs processes unchallenged experience in antibody-drug conjugate (ADC) developing and manufacture, now offers a tailor-made solution to characterize thepharmacokinetics (PK) properties of your ADCs.

Pharmacokinetics( PK )characterization

ADCs couple the highly desirable pharmacokinetic (PK) profile and target ability of monoclonal antibodies with the potent cytotoxicity of small molecule drugs. Such a combination can potentially minimize dose-limiting toxicities while maximizing desired therapeutic effects. The versatility of antibodies and the increasing sophistication of bioconjugation methods have moved ADCs into the forefront of next-generation therapies for a widening pool of diseases,especially cancers. A key aspect of development for any therapeutic agent is having a good understanding of the relationship between exposure to the drug and its pharmacological and toxicological effects. This is particularly complicated in the case of ADCs. Since a typical ADC consists of two pharmacologically distinct components, the monoclonal antibody and the cytotoxic drug payload, and cytotoxic drug can be attached to the antibody at different sites with different quantity through various linkers, resulting in the structural complexity and heterogeneity of the ADC. In addition, the pharmacokinetic characteristics of an ADC are primarily driven by the antibody component, and the linker and toxin components can impact the PK of the same antibody in different ways. Therefore, it is of great importance to monitor the behavior and fate of each component as well as their contribution to the PK characteristics of the whole ADC molecule, in order to capture comprehensive pharmacokinetics behaviors of this complex molecule. Creative Biolabs has highly qualified groups, advanced technologies and wide platforms to help you have a better understanding of your ADC PK properties. At Creative Biolabs, the monitored analytes for ADC PK characterization include total antibody (both conjugated and unconjugated antibody), conjugated antibody, unconjugated antibody, antibody-conjugated drug and free (unconjugated) drug. Numerous types of methods are available for a wide range of analytical approaches in the application for the PK characterization of your ADC candidates. By taking advantage of the sophisticated ADC PK characterization strategy, Creative Biolabs delivers to customers the most comprehensive ADC PK profile which contains, but not limited to:

  • the assessment of antibody-related PK behavior of the ADC by the characterizing total antibody;
  • the estimate of the active ADC concentration by assessing conjugated antibody;
  • the estimate of active drug associated with antibody by analyzing antibody-conjugated drug;
  • the assessment of systemic toxicity caused by free drug;

The analysis services of ADC we can offer include but not limited to:

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