Multi-Equilibrium DIALYZERTM
| Origin | USA |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Multi-Equilibrium DIALYZERTM |
| Pricing | Available Upon Request |
Overview
The Multi-Equilibrium DIALYZERTM is a high-throughput, benchtop equilibrium dialysis system engineered for precise, parallel assessment of ligand binding, protein–drug interactions, and free fraction quantification in biological matrices. Operating on the principle of passive diffusion across semi-permeable membranes under thermodynamic equilibrium conditions, the instrument enables simultaneous dialysis of up to 20 samples—each accommodated in a dedicated, individually sealed chamber with a maximum sample volume capacity of 5 mL. Designed for reproducibility in pharmacokinetic (PK) and pharmacodynamic (PD) studies, the system maintains strict temperature control (typically 37 °C ± 0.5 °C) and minimizes convective mixing to ensure adherence to classical equilibrium dialysis theory. Its architecture supports both manual and semi-automated workflows, making it suitable for early-stage drug discovery, ADME profiling, and regulatory bioanalytical method development.
Key Features
- Parallel processing of up to 20 independent samples per run, significantly reducing assay turnaround time and inter-run variability.
- Individual 5 mL sample chamber design with precision-machined, low-binding polypropylene housing and standardized molecular weight cutoff (MWCO) membrane support fixtures.
- Integrated temperature-regulated water jacket or Peltier-based thermal management system ensuring stable incubation at physiologically relevant temperatures (e.g., 37 °C, 4 °C, or room temperature).
- Modular dialysis plate configuration compatible with standard 96-well footprint formats, enabling seamless integration with liquid handlers and plate readers.
- Sealed chamber architecture minimizing evaporation loss (<0.5% volume change over 24 h) and preventing cross-contamination between samples.
- Compliance-ready mechanical design supporting audit trails, user access levels, and electronic record retention when paired with validated laboratory information management systems (LIMS).
Sample Compatibility & Compliance
The Multi-Equilibrium DIALYZERTM accommodates a broad range of biological specimens—including human and animal plasma, serum, cerebrospinal fluid (CSF), tissue homogenates, and buffered protein solutions—without requiring pre-dilution or matrix modification. Membrane compatibility extends to commercially available regenerated cellulose (RC), cellulose ester (CE), and polyethersulfone (PES) dialysis membranes with MWCOs ranging from 3.5 kDa to 100 kDa. The system meets foundational requirements for GLP-compliant studies per OECD Principles of Good Laboratory Practice and supports alignment with ICH M3(R2), FDA Guidance for Industry on Drug Interaction Studies, and EMA CHMP reflection paper on plasma protein binding. All wetted components are USP Class VI certified and non-pyrogenic.
Software & Data Management
While the core hardware operates in standalone mode, optional companion software provides protocol scheduling, temperature logging, run-time monitoring, and export of timestamped metadata in CSV and XML formats. Audit trail functionality records operator ID, start/stop times, temperature deviations (>±0.3 °C), and membrane lot traceability—fully compliant with FDA 21 CFR Part 11 when deployed on validated computing environments. Data outputs integrate natively with PK/PD modeling platforms such as Phoenix WinNonlin and NONMEM via standardized import templates. Electronic signatures, role-based permissions, and encrypted local storage are configurable per institutional IT security policies.
Applications
- Quantification of unbound (free) drug fraction (fu) in plasma for clearance prediction and interspecies scaling.
- Characterization of binding affinity (Kd) and stoichiometry (n) for small molecules, peptides, and antibody–drug conjugates (ADCs).
- Assessment of competitive displacement in presence of endogenous binders (e.g., albumin, α1-acid glycoprotein) or co-administered therapeutics.
- Supporting regulatory submissions under FDA IND/NDAs and EMA Marketing Authorization Applications where equilibrium dialysis remains the reference method for plasma protein binding determination.
- Method qualification per USP and ASTM E2821–12 standards for binding assay validation (precision, accuracy, stability, dilution linearity).
FAQ
What is the recommended incubation time to reach true equilibrium?
Equilibrium is typically achieved within 4–6 hours for low-molecular-weight compounds (<500 Da) and up to 24 hours for larger biologics; validation per compound and matrix is required.
Can the system be used with radioactive or highly potent compounds?
Yes—chamber sealing and modular design support containment compliance when used within certified fume hoods or isolators meeting ISO 14644-1 Class 5 environments.
Is membrane pre-treatment required before use?
Standard pre-hydration and buffer equilibration per manufacturer instructions are mandatory; no additional chemical activation is needed.
How is carryover controlled between runs?
Each chamber is single-use per protocol; reusable fixtures undergo validated cleaning cycles with sodium hydroxide (0.1 N) and ultrasonic rinsing per SOP.
Does the system support non-37 °C incubation for stability or cold-chain studies?
Yes—temperature setpoints are programmable from 4 °C to 45 °C with ±0.3 °C stability over 24-hour periods.
