Oral and IV clinical Manufacturing
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.
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.
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 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 or fully automated equipment at a scale of up to fifty 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
- Nano-suspensions 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.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationThe annual dinner meeting and innovation celebration will be attended by Masha Kononov, Senior Director Emerging Pharma US.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationDates: 7th FebruaryLocation: New Brunswick, NJ
CED Life ScienceThe CED Life Science Conference will be attended by Masha Kononov, Senior Director Emerging Pharma US and Gail Frey, Senior Director Key Accounts US.
CED Life ScienceDates: 16th - 17th FebruaryLocation: Raleigh, NC
Drug Delivery & Formulation SummitThe DDF Summit 2019 will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
Drug Delivery & Formulation SummitDates: 11th - 13th MarchLocation: Berlin, Germany