Analytical Development

Our in-house Analytical Development Team is expert in development, invention and verification of methods and assays in support of early stage programs in biopharmaceutical production.

The Analytical Development group form an integral part of the program team 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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