About Us

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.

meet the team

Dr Alan Wilkinson (Director)Dr Alan-Shaun Wilkinson is a chemist with particular knowledge, understanding and research experience in the application of physicochemical as well as bioanalytical techniques to the understanding and development of biological molecules for therapeutic use. Dr Wilkinson has been engaged in the development of a raft of bioanalytical assays over the past 20 years, including cellular assays that are key to understanding the biological efficacy of protein based drugs. Dr Wilkinson has considerable expertise in relating protein structure to activity and has applied this to the study of monoclonal based molecules, enzyme targets and other protein receptor molecules.
Prof Mike Allwood (Director)Prof Allwood has over 30 years of expertise within the pharmaceutical healthcare arena. He is well known for his experience and research into the stability of a wide range of parenterals products, such as antibiotics and parenteral nutrition, with particular reference to the needs of products suitable for the home care and hospital pharmacy market. It is in these key markets where the assigning of extended shelf lives is essential to provide convenient and cost effective services for High-Tec medicinal products. Prof Allwood is a consultant for a number of home healthcare companies, advising on the formulation, stability and safety of parenterals in a variety of delivery devices and forms.
Becky Finnis (Research Scientist)B.Sc. Becky Finnis is a research scientist with 10 years’ molecular biology experience in a research laboratory. She is responsible for assisting with designing and validating biological analytical assays, including ELISA and Bioanalyzer methods. Becky is also responsible for quality compliance and document control.
Dr. Andy Wallace (IT Administrator / Research Scientist)Dr. Andy Wallace has a background in Physical Chemistry and, more recently, over 10 years’ experience in front line IT support. Andy is also a self-published (independent) author. In his capacity as our IT Administrator, Andy carries out general day-to-day IT and technical support for BSTL. However, his role at BSTL also incorporates the authoring of standard operating procedure documents for our laboratory equipment, COSHH and Risk assessments, website updates, and data processing, as well as laboratory work – in particular, the operation of our particle counting instruments.