Support Services
Nova realises that customers require more from their manufacturing partners than simply a high quality production service. We therefore provide a number of other services in support of our manufacturing operations.
01 Analytical Services
A wide range of testing services is available on site to support Nova Laboratories manufacturing activities:
- Our microbiology group provides testing and method validation support for total viable counts, sterility (membrane filtration and direct inoculation using gassed isolators) and bacterial endotoxins using a sensitive kinetic chromogenic technique
- The analytical chemistry group have extensive experience in the testing of both small organic molecules and larger molecules such as proteins. There is a wide variety of techniques available at Nova to support the testing of raw materials and drug products that includes:
- HPLC
- UV and FTIR spectroscopy
- Protein analysis (e.g. ELISA, IEF and SDS-PAGE)
- Particle size distribution analysis (nano-metre to micron ranges)
- Sub-visible particulate counting of parenterals
- Karl Fischer for water content
- Dissolution testing
- In addition, Nova can develop and/or validate test methods, or manage the method transfer from a third party, depending on customer requirements
- As well as drug product release testing, Nova can also project-manage customer stability studies, providing testing in-house, liaison with sub-contractors where required and final data reporting, to help provide an integrated solution from manufacture to clinical product release and ultimately to setting a shelf-life for commercial product