Biologics, distinct from traditional small molecules, are advanced medicines based on macro-biomolecules or whole cells and tissues. Typical biologics include antibodies, recombinant proteins, antibody-drug conjugates (ADC), RNA-based vaccines, cell therapies, hormones, etc. The production, assessment, and conduction of trials with biologics require advanced mechanistic models, quality control systems, and risk assessment.
Using modeling approaches, ESQlabs assists in the development and regulatory filing of biological therapeutic solutions. Our modular way of working allows the efficient recombination of specific mechanisms of action with our base PBPK models to create customized models for specific modalities.
Types of prediction
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Whole-body PBPK prediction of concentration-time profiles for large molecules by integrating dedicated mechanisms for their absorption, distribution, metabolism, and excretion (ADME)
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Integrated Target-Mediated Drug Disposition (TMDD) Whole-body PBPK models to predict pharmacokinetics and, target engagement and effect
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Integrated mechanistic PD/QSP models with whole-body PBPK models to predict effects across modalities, species, patient populations and indications
Types of application
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In-silico optimization of drug properties such a (relative) affinities for multiple targets, binding kinetics, target-mediated internalization rates, payloads, etc.
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Analysis of preclinical and clinical studies to obtain mechanistic insight and parameter values for lead selection and study design
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Clinical trial optimization and prediction of FIH, special population and DDI trial results