Caco-2 Permeability Assay
In early drug discovery, lead optimization and preformulation development, intestinal membrane permeability is a core biopharmaceutical indicator that directly determines the oral absorption efficiency and bioavailability of small-molecule drugs. As the gold-standard in vitro cell-based permeability assay recognized by global pharmaceutical regulatory authorities (FDA, EMA, ICH), the Caco-2 Permeability Assay uses human colon adenocarcinoma cell lines to simulate the structural and functional characteristics of human intestinal epithelial monolayers, enabling comprehensive evaluation of passive transcellular diffusion, active transport, and efflux transport of drug compounds.
As a professional pharmaceutical CRO institution, PharmaAnalytica provides GLP-aligned Caco-2 Permeability Assay Services tailored for lead compounds and drug candidates. Our service adopts standardized cell culture protocols, strict quality control systems and mature detection processes, delivering accurate, reproducible and regulatory-defensible permeability data. Unlike PAMPA (only for passive permeability evaluation), our Caco-2 assay fully simulates complex intestinal absorption mechanisms in vivo, providing a full range of data support for lead prioritization, BCS classification, formulation optimization and IND regulatory submissions.
Applications in Lead Studies
- Comprehensive Intestinal Absorption Prediction: Evaluate both passive and active transport permeability of lead compounds, accurately predict in vivo oral absorption rate and bioavailability, superior to single passive permeability screening.
- BCS & BDDCS Classification: Combine equilibrium solubility data to complete Biopharmaceutics Classification System (BCS) and Biopharmaceutical Drug Disposition Classification System (BDDCS) categorization, supporting formulation design and regulatory waiver applications.
- Drug Efflux Transport Assessment: Detect efflux effects mediated by P-gp and other transporters, evaluate efflux ratio, and screen compounds with low efflux risk to avoid poor oral absorption.
- Lead Compound SAR & Permeability Analysis: Compare permeability differences among structural analogs, guide molecular modification, and optimize the balance between drug activity and intestinal permeability.
- Formulation Permeability Evaluation: Assess the effects of solubilizers, absorption enhancers and dosage forms on compound permeability, support early preformulation optimization.
- Regulatory-Compliant Data Support: Provide standardized permeability data for IND filings, bridging in vitro and in vivo correlation (IVIVC) research.
PharmaAnalytica's Technology Platform
BX-100C Carbon Dioxide (CO₂) Incubator
The BX-100C adopts direct heating air jacket design with three temperature zones and 8-unit six-sided heating, realizing rapid temperature rise and uniform temperature distribution, with temperature control accuracy up to ±0.1°C and CO₂ control precision of ±0.1%vol, stably maintaining the core culture conditions of 37±0.1°C and 5% CO₂ for Caco-2 cells.
DNM-9602G Microplate UV-Vis Reader
DNM-9602G is a high-sensitivity UV-Vis microplate reader for quantitative detection of drug compounds in Caco-2 assay samples. It features a wide wavelength range (200-1000 nm), low baseline noise and high detection accuracy, supporting rapid 96-well plate reading and automated data calculation.
PharmaAnalytica's Caco-2 Permeability Assay Services
GLP-Aligned Standardized Process
Full-process SOP management, regular cell quality verification (TEER value detection, alkaline phosphatase activity validation), ensuring each batch of data is reproducible and regulatory-defensible.
Professional Cell Laboratory Team
Operated by experienced cell biology technicians and pharmaceutical R&D experts, proficient in Caco-2 cell culture and data interpretation, with rich experience in lead compound testing.
Flexible Customized Service
Support bidirectional transport testing (apical to basolateral / basolateral to apical), pH adjustment, inhibitor co-incubation and other customized schemes according to project needs.
Regulatory-Ready Complete Deliverables
Provide detailed test reports including cell culture records, integrity verification data, raw detection data, Papp calculation results and expert analysis, fully supporting ICH and FDA regulatory submissions.
For oral drug development, accurate intestinal permeability data is the key to reducing late-stage R&D attrition. As a professional pharmaceutical CRO institution, PharmaAnalytica's Caco-2 Permeability Assay Service relies on a standardized cell platform, certified domestic instruments and a professional technical team, providing reliable, physiologically relevant permeability data for drug research and development. We help clients efficiently complete lead prioritization and formulation optimization, accelerating the progress of drug candidates from early discovery to clinical development.
Online Inquiry
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Need More Information or Request A Quotation?
Related Links
