Drug Product

Our qualified and experienced microbiologists pride themselves on applying their knowledge and skills to ensuring that pharmaceutical products are safe and meet today’s rigorous quality specifications and regulatory standards. We support clinical manufacturing and quality control for both non-sterile and sterile products.

Facilities and Equipment

Our purpose built microbiology suite comprises a media preparation area (including a media autoclave, two microbiology assay rooms with microbiological safety cabinets and a laminar air flow cabinet), a Grade C cleanroom with a Grade A positive pressure isolator and a waste disposal area complete with discard autoclave. The suite is equipped with a range of equipment such as continually monitored incubators, sterility testing apparatus, water baths, cold storage and microscopes.

Services

A full method development/validation service is offered to support application of the following key microbiological techniques and as method development, validation and testing can all be performed at one Arcinova facility, there is no need for time consuming technology transfer activities. In addition, we are equipped to perform microbiological testing on radiolabelled, highly potent, cytotoxic and controlled substances.

Our on-site microbiologists can assist manufacture through microbial monitoring and simulation tests. Quality control for sterile product release testing involves sterility, endotoxin and in-process testing. Microbiological enumeration and tests for specified microorganisms are also supplied for the quality control testing of non-sterile products.

Microbiological Aspects of Formulation Development:

• Preservative Efficacy testing
• Customised Challenge testing
• In-use testing

Clinical manufacturing support:

• Environmental monitoring including settle plates, active air sampling, enumeration, isolation and if required, the identification of isolates
• Microbiological aspects of process simulation tests (media fills) including turbidity examination and fertility checks on media
• In-process Sample Analysis (bioburden testing)
• Closure Integrity Testing by simple immersion or by pressure/vacuum.

Quality control release testing:

• Microbial Enumeration (Total Aerobic Microbial Count & Total combined Yeasts/Moulds Count) by pour plate and membrane filtration
• Test for Specified Microorganisms (Escherichia coli, Staphylococcus aureus, Salmonella species etc.)
• Sterility Testing – testing performed in a positive pressure isolator with a validated VHP cycle
• Closure Integrity Testing by simple immersion or by pressure/vacuum.
• The identification of isolates
• Bacterial Endotoxin Testing (gel-clot and kinetic)

 Other microbiological services:

• Drinking Water Testing
• Pharmaceutical Water Testing
• Microbiological Environmental Monitoring
• Phenotypic Identification

Our teams have many years’ experience in the provision and interpretation of high quality analytical, microbiological and materials science based stability data. 

These studies are supported by our state-of-the-art, 'walk-in', ICH compliant stability chambers and a number of smaller, reach-in, units for investigative studies and ICH compliant photo-stability testing equipment. Stability testing services can be provided for discrete client projects or as part of an integrated CMC service provision. 

The Arcinova Quality Control (QC) testing team is responsible for the analytical testing of material within drug substance, drug product and isotopic labelling divisions. Our Qualified Person (QP) certifies Investigational Medicinal Products (IMP) prior to release.

For Drug Product QC testing, we analyse clinical products and IMPs based on pre-approved specifications. Our testing methodologies are developed and validated on-site, with the release of products performed by our in-house QP before distribution to clinical trials.

We follow British and US pharmacopeia reference standards for testing raw materials and excipients. Our full stability testing allows clients to be confident of the essential storage-dependent characteristics of their product. Forced degradation studies are also used to determine what happens to material during severe and accelerated conditions. Our identification services utilise a wide range of equipment to determine material characteristics, including mass-spectroscopy, NMR, X-Ray Diffraction and Refractive Index Detectors.

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.

Manufacturing Capabilities

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.