Challenge Themes

Process Analytical Technologies and Industry 4.0

We know that typical ATMP bioprocessing methods are highly variable and challenging to characterise, and we are committed to improving understanding of this process.

Building on several years of investment in the development of improved bioprocessing and automation, we have created a specialist facility that is dedicated to enable the rapid generation of detailed and automated process understanding. From this detailed understanding it becomes possible to derive verifiable critical process parameters more quickly, around which we can create rapid feedback loops using in-line and at-line technologies to control product quality.

We invite partners to our new Process Analytical Technologies lab, where we can collaboratively develop the type of detailed process understanding necessary to improve outcomes and satisfy regulatory authorities.

Learn more about our bioprocess control and automation capabilities

Driving efficiency of Adeno-Associated Virus (AAV) production

We recognise that gene therapy developers still face major challenges in achieving sufficiently high quality, high yield processes. To further reduce the cost of goods associated with viral vector manufacture, in particular with AAV bioprocessing, we are increasingly focussing our R&D in improving the performance of specific unit operations, including improved cell line performance, plasmid design-based solutions, purification and scale.

We have created an end-to-end suspension based AAV manufacturing process that has been transferred into GMP and are looking to support tech transfer activities for third parties that want to improve their vector manufacturing and analytical capability.

We are keen to share and develop our knowledge with partners in an effort to accelerate the creation of more cost-effective manufacturing solutions.

Learn more about our viral vector capabilities

Improving scalability and control of allogeneic cell therapies

We understand the difficulties associated with achieving scalable, closed and controlled, GMP compliant processes for pluripotent stem cell (PSC) derived products, especially while drivers of induced-PSC lineage are undefined. In alignment with overcoming this challenge, our allogeneic research focus is on uncovering the genetic factors which influence iPSC lineage bias.

Extensive experience with allogeneic cell therapies has enabled us to develop robust processes to accelerate the therapeutic potential of PSCs. Having successfully scaled up our high-density PSC expansion process, we are now developing genetic and bioprocessing based interventions that can robustly control differentiation.

We are interested to work with other groups who are looking for support with PSC expansion or iPSC lineage bias and share our motivation to bring forward allogeneic cell therapies.

Learn more about our stem cell expansion & differentiation capabilities

Building Consortia

Access a unique convening power for large scale collaboration

Our unique operating model allows us to build consortia, mobilising key industry stakeholders to drive understanding around the challenge themes. We bring the right people together in this unique way, to overcome substantial challenges and accelerate the progression of cell and gene therapies. By harnessing leading industry players and collaboratively sharing learnings and data, we can generate the combined knowledge needed to overcome common challenges, at reduced cost and investment risk to each organisation involved.

Please get in touch if you are interested in being part of a consortium surrounding any of our recognised challenge themes. Additionally, if you have suggestions for new challenge theme focus areas and consortium opportunities, we want to hear from you.