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Formulation Development

Arcinova have established expertise and technologies that are routinely applied to the understanding of active pharmaceutical ingredients (APIs), how best to formulate them for clinical and non-clinical applications, what their stability characteristics are and how to manufacture the formulations of choice reproducibly.

Formulation development programs can be conducted in isolation but are most powerful when combined with some or all of the synthetic, analytical, microbiological, clinical product manufacturing and regulatory CMC expertise available within Arcinova.

Our range of services related to drug product include:

• Materials science and spectroscopic investigations

• Non-clinical formulation development (oral and IV)

• Clinical formulation development (oral and IV) 

• Stability testing

• Clinical Product Manufacture (oral and IV)

• Clinical product manufacture (Cytotoxic/high potency/radiolabelled products)

• QC testing and QP release

 

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