From In Vitro ADME to Immunogenicity Assessment
Assessing pharmacokinetics and immunogenicity is pivotal for decision-making and development optimisation at the early stage of a drug development project. With extensive experience in bioanalysis, Creative Biolabs conducts comprehensive in vitro ADME and anti-drug antibody (ADA) studies to help researchers understand the drug's potential in vivo behaviour and associated immune risks before entering the preclinical stage.
In vitro ADME studies, covering absorption, distribution, metabolism, and excretion, reveal how a compound behaves within the body, which is fundamental for lead optimisation.
Creative Biolabs provides a complete set of high-quality assays, including:
- Metabolic stability testing: Utilising human or animal liver microsomes and hepatocytes to assess metabolic rate and half-life
- Plasma protein binding assay: Determining the free drug fraction in plasma through equilibrium dialysis or ultrafiltration
- Caco-2 permeability assay: Simulating intestinal epithelial absorption to predict oral bioavailability
- CYP450 inhibition and induction testing: Assessing possible drug-drug interaction and metabolic safety
These experimental results will support pharmacokinetic modelling, toxicity assessment, and clinical dose design.
Meanwhile, the detection of ADAs is no less significant in the development of biologics. Almost all protein- or antibody-based therapeutics may elicit ADA formation, which can reduce therapeutic efficacy and cause immune-related adverse effects.
Following FDA and EMA guidelines, Creative Biolabs has established a sensitive and specific multi-tier ADA testing system, including:
- Screening and confirmatory assays: For the identification and verification of ADA-positive samples
- Titer and neutralising antibody assays: Quantifying ADA levels and assessing their impact on drug activity
- Method development and validation: Customising analytical strategies in accordance with molecular characteristics and clinical stages
By integrating ADME and ADA studies, research teams can achieve a comprehensive understanding of candidate drugs' pharmacokinetic and immunological profiles, establishing a strong foundation for subsequent development.
A senior scientist at Creative Biolabs said, "Obtaining high-quality pharmacokinetic and immunogenicity data at an early stage is critical for determining whether a candidate can advance to clinical trials. Our team develops bespoke analytical designs to assist clients in tracking down potential issues early in development."
