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Method Validation Services
FromBiodextris
Validation of a method is a critical step of development work. We, at Biodextris, validate your assays to demonstrate that the appropriate performance criteria are met, and the analytical target profile is achieved. Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R1).
Most popular related searches
size exclusion chromatography
method validation
ELISA
HPLC
laser light scattering
light scattering particle
polyacrylamide gel electrophoresis
liquid chromatography
particle sizing
particle size distribution
We assess and verify the following assay parameters as appropriate for your project:
- Specificity
- Range
- Accuracy
- Precision
- Repeatability
- Intermediate Precision
- Linearity
- Detection Limit
- Quantification Limit
- Robustness
USP methods are performed as defined, or are adapted, customized and validated as appropriate.
CATEGORY: TECHNIQUE/EQUIPMENT: OBJECTIVE
- Physico-chemical:
Capillary isoelectric focusing (cIEF): separation of protein variants - Microfluidic electrophoresis: automated protein sizing and relative quantitation
- HPLC-RP/IEX with PDA/CAD/Fluo: High Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion with Photo Diode array or Charge Aerosol or Fluorescence detection: Content or purity determination of proteins or small molecules
- UPLC-PDA-MS/MS: Ultra Performance Liquid Chromatography with Photo Diode Array or Tandem Mass Spectroscopy detection: Multi-analyte determination
- LAL Endotoxin: Limulus amebocyte lysate assay: Quantification of residual LPS or endotoxin
- Colorimetry (optical density, absorbance and transmission) cuvette and multiwell plate.: Optical quantification, BCA, Lowry etc.
- SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis: Size separation and purity determination
- Biophysical:
- SEC-MALLS: Size-exclusion Chromatography with Multi-Angle Laser Light Scattering: Direct molar mass and size distribution
- SEC-FLUO/UV: Fluorescence or ultraviolet-detection Size-exclusion Chromatography: Aggregation determination
- DLS: Dynamic Light scattering: Particle size and size distribution determination
- Nephelometry: Detection of insoluable particles
- Immunological:
- Western Blot: Size separation and antigen specificity characterization
- ELISA: Enzyme-Linked Immunosorbent Assay: Antigenic activity and identification
- qPCR: Quantification of target or residual DNA
- SRID: Single Radial Immunodiffusion: Hemagglutinin potency assay
- General:
- Osmolality: Aqueous/freeze dried solutions: Enumeration of moisture content
- pH: Aqueous solutions: Levels of acidity or alkalinity determined
- Turbidity: Measurement of relative clarity of a liquid against guidelines or specifications
- Viscosity (Brookfield method): Viscosity, or , flow resistance of liquid in stated conditions
- Photostability: Simulated prolonged light exposure stability studies
- Visual Inspection (EP and USP): Observation according to noted standards
- Cell-based assays: Potency of target molecules