Differential scanning calorimetry (DSC) and thermogravimetric analyses (TGA) are used for both routine and investigative studies, where either physical characterisation, chemicial purity, nature of solvent-crystal/amorphous interactions or an understanding of excipient compatibility is required. Thermogravimetric Analysis (TGA) measures the mass of a sample as the temperature changes, and can be applied to salt selection and polymorph screening. Fast scan DSC or modulated DSC experiments can be readily implemented to address complex physical behaviours that may be incurred on heating. Under some circumstances, DSC is used to quantify crystalline or amorphous content of either drug substances or products. It can also be employed for determining excipient compatibility during formulation development.
Get In TouchLiquid/Solid State NMR is used to provide data about the materials science aspect of APIs and their products. Understanding molecular structures and their dynamics is fundamental to the drug discovery and development process.
Solid State: Solid-state NMR (ssNMR) is a non-destructive and non-invasive technique used to determine the structure and dynamics within solid drug substances and drug formulations. ssNMR data is essential for those seeking to fully understand the materials science aspects of Active Pharmaceutical Ingredients (APIs) and their products. This technology and the associated interpretive expertise is available within Arcinova and can be accessed either in isolation or as part of an integrated approach to pharmaceutical engineering and problem solving.
Solution-State: Understanding molecular structure and dynamics is fundamental to many aspects of drug discovery and development. Arcinova’s NMR facilities and associated interpretive expertise provide a means of rapid structure elucidation to deliver crucial information across a diverse range of applications, including those requiring the analysis of Carbon-14 material.
Get In TouchOur 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.
Arcinova’s on-site microbiologists can assist manufacture through microbial monitoring and simulation tests. An advantage of having specialists close at hand during process testing is that samples can be taken as close to the source as possible. 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
Get In TouchOur 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.
Get In TouchOur accredited GMP/GLP laboratories and trained personnel work closely with on-site Quality Assurance to provide testing and release in accordance with regulatory requirements. With a well-established Quality System, and extended capabilities to include analysis and release of radiolabelled drug substances and products, delivery of accurate data in accordance with the desired timeframe and associated cost savings are achieved on a routine basis. We supply high quality stability testing, which is critical for ensuring suitable re-test dates or shelf-lives are applied during all clinical phases.
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.
Get In TouchOur team utilises their extensive experience to develop, validate and apply GC (headspace or direct injection), ion chromatography, LC and UPLC-based methodologies. Our facilities include a range of LC detector types including UV, DAD, N2 emission, radiochemical, ICP-MS, conductivity, fluorescence and CAD. Our LC/MS technologies comprise single quadrupole, triple quadrupole and accurate mass.
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