Download Title, Protein drug stabilisation for long term shelf life

Title, Protein drug stabilisation for long term shelf life.
Supervisor, Andrew Ingham
Overview of research to be undertaken
Proteins are developing into a huge market for pharmaceutical
companies. In May 2006, Human Genome Project researchers
announced the completion of the DNA sequence for the last of
the 24 human chromosomes. Conclusive data allowed many
medical researchers to take huge leaps forward with research.
The Pharmaceutical industry has benefited with large numbers of
protein and DNA drugs moving towards the market place.
Both DNA and protein solutions have stability problems, breaking
down quickly in an aqueous environment. This can happen even
in the presence of buffers or when the solution is frozen. Ideally
the pharmaceutical industry requires a stable product for at least
2 years to allow the sale and use of the product. The process of
lyophilisation (freeze drying) is one potential for transforming
unstable solutions into dry stable powders that can be
compressed into tablets or re-suspended at a later date.
The process of lyophilisation relies on properties of water
allowing it to be transformed from the frozen state to a gas
without passing through the liquid state. Water is sublimed
directly from the frozen state to the gas state. The United States
National Aeronautics and Space Administration (NASA) saw the potential of this technique to
send food to its astronauts in space. The pharmaceutical industry has seen the potential for a
new generation of protein medicinal products.
You will conduct research with regard to the lyophilisation of the enzymes Galactosidase,
Aspariginase and Amylase, investigating the potential and extent of the lyophilisation damage
caused to the enzyme. You will use a lyoptotectant co-solvent system, and will test novel
lyoprotectants to include tri-saccharides. Within the laboratory you will work with a pilot scale
Freeze Dryer simulating industrial freeze drying cycles.
A candidate with an inquisitive mind and the ability to :
 Multitask between different laboratory areas,
 Develop a technical working knowledge of the freeze drying process and control
systems,
 Combine and present complex data collected electronically within Excel.
Will benefit from :
 The interdisciplinary nature of the project bridging biology and pharmaceutical
sciences,
 Industrial lyophilisation process design aided by key Industrial scientists,
 Research with process measurement devices for pressure, temperature and
moisture content still at a developmental stage.