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Analytical Development

Companies choose to work with us because we are experts in developing complete analytical packages for novel and complex vaccine and biologic products.

KNOW YOUR PRODUCT
Method Development

We support you in the design of a suite of analytical assays that assess the important and critical quality attributes for your unique product.

Assay development is customized to suit this target product profile. Our scientists follow a systematic structured methodology to develop the optimal assay for your product.

HPLC
Immunological assay

KNOW YOUR ASSAY
Method Validation

We validate your assays to demonstrate that the appropriate assay 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).

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.

STAY IN CONTROL
Method Transfer

We can transfer methods to or from your facilities or partner facilities as required.

 

AVAILABLE ANALYTICAL TECHNOLOGIES

CATEGORY TECHNIQUE/EQUIPMENT OBJECTIVE
Physico-chemical HPLC-RP/IEX/SEC 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
GC-MS: Gas-Chromatography Mass Spectrometry Separation, identification and quantification
ICP: Inductively-Coupled Plasma Trace element identification
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 Color quantification
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
FFF-MALLS: Field Flow Fractionation with Multi-Angle Laser Light Scattering Molar Mass and size distribution determination
DLS: Dynamic Light scattering Particle size and size distribution determination
Immunological Western Blot Size separation and antigen specificity characterization
ELISA: Enzyme-Linked Immunosorbent Assay Antigenic activity and identification
Threshold DNA Quantification of target or residual DNA
SRID: Single Radial Immunodiffusion Hemagglutinin potency assay