Drug Product Manufacture

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. A range of product types are developed, including those containing highly potent, cytotoxic or radiolabelled  APIs, the most common being:

  • Solutions (aqueous and non-aqueous), suspensions and intravenous formulations for clinical or non-clinical use
  • API in a capsule or API in a vial with an appropriate aqueous or non-aqueous constitution solvent for early phase clinical trials (including AME studies)

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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