CMC

Clinical Manufacturing, QC Testing and Supply

The expertise to develop, manufacture, test, release and supply a range of clinical product types is available within Arcinova and can be accessed on a transactional basis or as part of integrated and extensive, pharmaceutical development services.

Approach

Typically, a range of product types will be required during the clinical program, from relatively simple dosage forms in phase I to those warranting greater investment as the molecule’s probability of success increases.

Dose forms developed by experienced scientists at Arcinova and their associated manufacturing processes, are fully documented and discussed prior to the manufacture of representative (technical) batches. These not only confirm the proposed process’ suitability but are also used to establish a shelf-life for the clinical products. GMP compliant clinical products are manufactured with comprehensive support from the in-house quality control and quality assurance teams and can be released by one of our Qualified Persons prior to shipment of the Investigative Medicinal Product (IMP) to the clinic.

Facilities

Our purpose built facility is licensed to manufacture both oral and sterile IMPs, including those containing cytotoxic and/or radiolabelled drugs. It contains warehousing, dispensing, manufacturing, clinical labelling and packaging rooms. The rooms are fully qualified and maintained to Grade D or C as appropriate with Grade A facilities available for the manufacture of sterile products. All areas are controlled to specified temperature and humidity limits with appropriate air pressure differentials between rooms, all of which are continuously monitored and recorded. In addition, routine cleaning and environmental monitoring schedules are applied.

Equipment

Equipment is available on site for the manufacture of a wide range of product types typically utilised in early clinical trials, including:

  • Liquids for oral administration (solutions, suspensions and emulsions) at a scale of up to 20 litres/batch

  • Aseptically prepared sterile products up to a 2 litre scale (equivalent to 200 x 10 ml vials)

  • Radiolabelled products for oral or intravenous human Absorption, Metabolism and Excretion (AME) trials

  • Capsules containing API, manufactured using semi-automated equipment at a scale of up to a thousand units/batch

  • Vials containing API and an associated solvent for product constitution prior to use at a scale of up to a thousand units/batch

  • Nanosuspensions prepared via ball milling or high pressure homogenization at the hundreds of mL to litre scale

Packaging and Supply

Clinical products are packed, labelled and assembled into IMPs prior to shipment to the clinical site using a chain of custody which extends from the Arcinova facility to a named individual at the receiving site.

 

Summary

The provision of high quality clinical supplies is critical to pharmaceutical development. Arcinova has the expertise and capabilities to develop, manufacture, test, release and supply a wide range of clinical dose forms to territories around the world.