A new drug analysis method

An international team of scientists has been working with a major biopharmaceutical company to investigate new ways to characterise protein formulations.

Co-led by The University of Western Australia’s (UWA) Associate Professor Vincent Wallace, the team includes scientists from the Universities of Cambridge and Sheffield as well as industry partner MedImmune, the global biologics research and development arm of AstraZeneca.

Writing in the Journal of Pharmaceutical Sciences, the researchers explain how terahertz (THz) spectroscopy is used to better understand the formulation of monoclonal antibody drugs to make medicines that can be used to treat a number of different diseases, including autoimmunity, oncology, neuroscience and infection. Terahertz spectroscopy detects the properties of matter with electromagnetic fields that are in the frequency range between a few hundred gigahertz and several terahertz.

“The biopharmaceutical industry are experts at packing monoclonal antibody drugs into a suitably small volume to give patients the option to self-administer by subcutaneous injection at home,” Professor Wallace said.

“However, as you increase the concentration of some antibody drugs, they can have a tendency to stick together, which the industry overcomes by formulation. Understanding of the exact role of water during formulation would be ideally complementary to the science underpinning that drug development process.”

The researchers explained that a special technique called terahertz time-domain spectroscopy (THz-TDS) has previously been shown to “detect overlapping extended hydration layers around proteins”. With this in mind, they “used THz-TDS to detect modulation of the extended hydration layer around monoclonal antibodies (mAbs) by the introduction of commonly used excipients”.

“Pretty much everything in biology is surrounded by water,” Professor Wallace said. “Using terahertz time-domain spectroscopy allows us to better understand the interaction of water and proteins, which is relevant to high concentration formulations. The biopharmaceutical industry may then be able to transfer this new analytical method into its drug development activities.”

The research follows the recent installation of a new commercial THz system in UWA’s School of Physics, said to be the first of its type in WA. According to Professor Wallace, the equipment will not only assist with the drug analysis research, but also in many other medical and non-medical applications.