UK consortium led by Paraytec Ltd in £1M+ project to develop novel analytical instrumentation to detect aggregation in biopharmaceutical processing

A multi-disciplinary UK consortium of partners including Avecia, Intertek ASG, Lonza, Paraytec and the University of Bradford has recently been awarded research grants by the Technology Strategy Board and the Engineering and Physical Sciences Research Council. The part funded £1M+ project is to develop novel analytical instrumentation to detect aggregation in biopharmaceutical processing. Aggregation or the 'sticking together' of molecules is a major problem in medicine. At best it can reduce the effectiveness of a drug and at worst it can have detrimental health effects.

Professor David Goodall, Chief Scientific Officer at Paraytec commented 'We are delighted to be lead partner in this project. Our award winning ActiPix D100 UV detection technology will play a central role in the novel analytical instrumentation. Our approach will enable simultaneous UV quantification and sizing to allow monomeric species of biopharmaceuticals to be readily distinguished from dimers and aggregates. For bioprocessing companies like Avecia and Lonza, an attraction of this technology is that UV detection is the method of choice for monitoring and quantifying biopharmaceuticals during separation and polishing stages. Thus the ability to gain additional information on size is seen as a significant benefit.'

As an academic partner, the University of Bradford will be fully supported by the EPSRC. Professor Rob Forbes of Biophysical Pharmaceutics at the University of Bradford and principal investigator said "This is an enormously exciting project bringing together a great consortium of expertise from different sectors. To be able to explore the usefulness of novel award-winning technology with real pharmaceutical innovation potential to help biopharmaceutical manufacturers develop protein medicines is great news. It is rewarding to know that the EPSRC through its life sciences interface recognised the good science that in this project will determine whether the molecules that make up the medicine are sticking together, and if so will allow a precise measure of the effect. This sticking together or aggregation can cause the medicine to lose efficacy or in the worst case cause the body to react adversely. I'm delighted that Bradford's School of Pharmacy has the opportunity to use its knowledge to make biopharmaceutical medicines work better and reduce costs."

John Birch from Lonza added "As a CMO Lonza is involved in developing manufacturing processes for a wide range of proteins. The ability to rapidly monitor and quantify aggregate levels at or on-line has great potential in process development and we are excited to be part of a project which looks at novel approaches to this challenge."

"Intertek ASG, working with the University of Bradford, will apply a range of existing technologies to the study of aggregation states in materials supplied by the consortium partners" commented Dr Nick Crabb, Intertek ASG Laboratory Director. "The objectives are to both position the ActiPix technology and to also derive best practice in aggregation studies across a range of technology options. Intertek ASG, along with other consortium partners, will also advise on features of the new instrumentation to facilitate qualification for use in highly regulated environments".

The development project will take place over the next two years. The project will be followed by commercialization of the instrumentation by Paraytec. For further information on this project please contact Paraytec Ltd.