Our laboratory is located at BioCity, Nottingham, and is equipped with state-of-the art facilities for performing analytical and biological testing. BioCity also provides access to additional high throughput analytical and bio-analytical testing equipment as well as high field NMR if required.
All of the capital infrastructure enables us to be uniquely placed to examine and assess the stability of both chemical and biological drug compounds in different administration devices. Our particular focus will be to assess the stability of biologicals including biosimilars. We have, for example, completed a study into the stability of Trastuzumab after dilution for injection in infusions.
This generated data allowing us to determine the physicochemical and in-vitro biological activity of the drug after dilution and storage. The investigation study was in close collaboration with a major NHS quality control laboratory. The outcomes are now being applied to assist with extending the shelf lives of injections of other reconstituted monoclonal drugs including Rituximab and Cetuximab, Inflixumab etc. The approach taken, which employs bespoke biological and analytical chemistry assays developed in-house, allows considerable cost savings to the customer in addition to benefits to patient care.
We are currently in the process of developing other bespoke bioassays for other high profile biological products in accordance with customer and healthcare requirements.
what we can do for you:
- Assessing the stability and shelf life of any parenteral drug in plastic syringes, IV bags and ambulatory delivery devices
- Assessing the interaction (sorption, extraction) of parenteral drugs with IV delivery systems, including administration sets, extension sets and in-dwelling catheters
- Assessing the chemical stability and biological efficacy of biological drugs, such as mAbs and Cytokines, in ready-to-administer delivery systems
- Assessing the chemical and physical stability of parenteral nutrition regimens
Our policies and procedures have been approved by our colleagues in the NHS Testing Laboratory and we are operating according to GLP. We are currently working towards meeting the requirements set down by the MHRA for future development when named on customers’ licences to ensure that the results and reports can be used directly by customers. This will be a near term goal for our growing business to meet all requirements of the medicines licensing conditions.