Demonstrating that every method is fit for purpose

Pharmaceuticals that are derived from biotechnological/biological processes have distinguishing characteristics which may necessitate complex analytical methodologies. The development and validation of such methodologies plays an important role in the discovery, development, and manufacture of these bio-pharmaceuticals. Our service offers the development and validation of regulatory compliant monoclonal and polyclonal bioassays that can be routinely used to support either stability testing or lot release.

With over 20 years experience in the development of technically challenging and sensitive ELISA assays we offer:

• Custom Assay Development
• Potency and purity methods
• Validation parameters that are routinely tested:
  • Accuracy/Recovery
  • Precision (repeatability & intermediate precision)
  • Calibration/Standard curve
  • Specificity/Selectivity
  • Quantitation/Detection limit
  • Linearity
  • Range
  • Stability of samples in matrix
  • Stability of standard stock solutions

We provide analytical chemistry and quality control support for Method Development and Validation in accordance with ICH guidance documents and current Good Manufacturing Practices.

For further information on our Global service offering please email pharmaservices@gen-probe.com