ADC in vivo Analysis

Antibody-drug conjugates (ADCs) are innovative next-generation immune therapy agents that combine the specific targeting capacity of a monoclonal antibody with cytotoxic drugs. They are designed for accurate drug delivery to minimize collateral damages to healthy tissues. With the antibody Fc region that triggers antibody dependent cellular cytotoxicity (ADCC) or complement dependent cytotoxicity (CDC) and the cytotoxicity of the payload drug, some ADCs exert a “two-fold” killing efficacy towards targeted cancer cells. Due to their unique nature, ADC in vivo evaluation is of crucial importance since this process provides information regarding their efficacy and safety, which serves as a prerequisite and a guideline for clinical trial design. As a well-recognized leader in ADC preparation and with over a decade of experience, Creative Biolabs is dedicated for the development of new therapeutic agents and we offer our clients with comprehensive high-quality services for ADC in vivo evaluation.

ADC In vivo Analysis

Creative Biolabs employs a variety of animals, including rodents, canine, or non-human primates, for the assessment of the in vivo pharmacokinetic properties, ADME pattern, efficacy, potential immunogenicity, and safety of an ADC.

  • ADC Pharmacokinetics Characterization— several key parameters, including total and conjugated antibodies, free and conjugated drugs, as well as catabolites are determined to reveal the preliminary pharmacokinetic (PK) properties of an ADC while a more comprehensive evaluation of the pharmacokinetics are assessed by measuring its ADME pattern:
    • Distribution-- tracking of the radioisotope labeled ADC by PET scan or postmortem radioactivity analysis.
    • Metabolism/catabolism-- postmortem analysis combining with LC-MS/MS to determine ADC metabolite and catabolite present in tissue.
    • Excretion-- analysis of the presence of ADC fragments in animal excreta.
  • ADC Safety Assessment— the toxicological property of an ADC is studied by acute- and repeat-dose toxicity tests, chronic toxicity test, and tissue cross-reactivity… under non-GLP or GLP-compliant test platforms.
  • ADC In vivo Efficacy EvaluationCreative Biolabs maintains a wide variety of human cancer cell lines for xenograft tumor model development and we apply genetically engineered mouse models for tumor formation and growth. The drug efficacy of an ADC is evaluated using those animal platforms to monitor tumor progression upon the administration of the ADC. Detailed cage-side observation and pathological analysis are also performed to provide a complete profile of the ADC drug efficacy.
  • ADC Immunogenicity Analysis— most ADCs are generated using human monoclonal antibodies or humanized antibodies to minimize immunogenicity and the toxic payloads are usually not immunogenic. However, as a newly formed bio-macromolecule, ADCs might present unexpected immunogenicity, an undesired feature for ADC performance. Creative Biolabs has established full analytical services to evaluate the potential immunogenicity of an ADC by detecting and quantification of the anti-drug antibody (ADA) after ADC deployment.

Creative Biolabs is equipped with outstanding animal facilities where all test animals are maintained in a clean and feed-enriched environment. All in vivo experiments are carried out following Institutional Animal Care and Use Committee (IACUC) approved protocols. With great devotion to our clients, Creative Biolabs offers highly customarily tailored in vivo ADC evaluation services and in vitro ADC analysis services to fit your timeline and research budget. Please contact us for more information and a detailed quote.

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