A longstanding collaboration between the University of Edinburgh and biomanufacturing company FUJIFILM Biotechnologies has led to the launch of a new protein purification platform designed to make the production of biological medicines faster and more straightforward.
FUJIFILM Biotechnologies, a global contract development and manufacturing organisation (CDMO) specialising in biologics, vaccines and advanced therapies, is presenting the platform, called ‘ShunzymeX™’, this week at the Festival of Biologics in San Diego.
Promise of biologics
Between a third and to half of new medicines currently being approved by regulators are biologics – medicines derived from living cells rather than chemical synthesis - and they offer promising treatments particularly for chronic autoimmune diseases, cancers and inflammatory conditions.
Their production involves engineering biology techniques - growing living cells that produce a therapeutic protein that is then purified. For many products, this purification step can be difficult, slow and expensive.
New solution
In the early 1980s, a solution was developed to allow small scale protein purification by adding a ‘tag’ onto the desired protein, then using it to ‘grab’ and isolate the protein. Whilst this technique is now standard, its sensitivity to different temperatures and pH, combined with the difficulty of completely removing the ‘tag’ from the protein, has prevented its use in industrial medicine manufacturing.
ShunzymeX, co-developed by Professor Emerita Lynne Regan of the University of Edinburgh’s School of Biological Sciences and FUJIFILM Biotechnologies, is a novel enzyme that has been specifically designed to overcome these challenges.
ShunzymeX works optimally within the temperatures and pH conditions required for biologics manufacturing at scale and, critically, cuts the tag so that it is completely removed from the therapeutic protein. The protein is left in its natural form, with no amino acids added.
Streamlining manufacture
For the first time, ShunzymeX will enable deployment of a reliable, ready-to-use purification step, streamlining the manufacturing process, in a less resource-intensive and more sustainable way.
John Stewart, Senior Vice President of Global Process Development at FUJIFILM Biotechnologies, said:
FUJIFILM Biotechnologies has over 30 years of experience in microbial innovations, exemplified with our Paveway expression system, coupled with a proven track record in process development and a history of advancing microbial technologies. Together with Paveway PLUS, we believe this innovation will help create a faster path for our customers to commercialisation. ”
The ShunzymeX technology is the product of a strategic partnership between Fujifilm and the University of Edinburgh dating back to 2018, followed by a Prosperity Partnership funded by the Engineering and Physical Sciences Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC)’s Impact Acceleration Accounts, both of which are part of UK Research and Innovation.
The technology, also funded by the Industrial Biotechnology Innovation Centre (IBioIC), has been licensed to the Fujifilm by Edinburgh Innovations, the University’s commercialisation service.
Dr Susan Bodie, Director of Innovation Development and Licensing at Edinburgh Innovations, said:
We are delighted to see a product like ShunzymeX out in the world and licensed to our longstanding collaborator, Fujifilm.
This kind of transformative partnership unlocks the power of new technologies we are developing by applying them to industry challenges, in this case, ultimately making treatments and vaccines for many millions of people easier to manufacture and more accessible. ”
Professor Susan Rosser, Chair of Synthetic Biology at the University of Edinburgh, is academic lead for the strategic partnership. She said:
Biologics, gene therapies and advanced therapeutics have the potential to revolutionise healthcare. Our strategic partnership with FUJIFILM Biotechnologies strives to tackle challenges in medicines manufacturing across the breadth of the process – from developing new production cell lines through to streamlining and improving the manufacturing process itself. ”
