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
Bio2Business 2018Bio2Business Basel 2018 will be attended by Nathalie Huther, Business Development Manager Europe.
Bio2Business 2018Dates: 19th - 20th JuneLocation: Basel, Switzerland
ChemSpec EuropeThe ChemSpec Europe Conference will be attended by Gareth Jenkins, Chief Scientific Officer at Arcinova. Gareth has been invited to chair 'Sessions 3 and 5' for the Royal Society of Chemistry's Special Symposium, during the two-day event.
ChemSpec EuropeDates: 20th - 21st June 2018Location: Cologne, Germany
Scale-up of Chemical Processes ConferenceThe Scale-up of Chemical Processes Conference will be attended by Nathalie Huther, Business Development Manager Europe.
Scale-up of Chemical Processes ConferenceDates: 25th - 27th JuneLocation: Prague