Analytical Method Development

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We can support our clients through the drug development journey from early phase process development to commercial manufacturing.

Analytical Method Development #1

Analytical Method Development

Gallus offers analytical development services to support process improvements and develops and performs assays for product characterization, or for development and transfer of methods to Quality Control for product release, in-process testing or validation activities.

Targeted Services

  • Release assay development/optimization
  • In-process testing method development
  • Assay transfer and assessment
  • Characterization assay development
  • Product characterization
    • Reference standard, clinical lots, non-cGMP lots, comparability studies
  • Process development support