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Fujifilm Diosynth Biotechnologies

Biopharmaceutical Process Development and Manufacturing Services

Analytical Development

Fujifilm Diosynth Biotechnologies

Our in-house analytical development team is expert in development, invention and verification of methods and assays in support of early stage programmes.

fujifilm diosynth

The analytical development group forms an integral part of the programme, ensuring that all process parameters affecting product quality are identified and fully understood. This enables the successful operation of quality by design in routine cGMP manufacture.

Assays will typically be developed that detect changes in:

  • The target protein and related species
  • Process impurities
  • Protein potency

After development, the assays are transferred to the quality control department to support cGMP manufacturing.

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