Medicines Manufacturing Challenge - Collaboration is the key to success!

The Medicines Manufacturing Challenge has supported and funded new collaborations between businesses with unique skillsets, with the same goal of solving complex manufacturing challenges. A recent partnership funded by the Medicines Manufacturing Challenge were Touchlight , CPI and Ipsen.

Improving the lives of patients is a key driver of partnership and collaboration. As we look to the future and the need for more personalised and diverse medicines, it is likely smaller, faster, and more agile manufacturing methods will be needed. Cell free expression technology could be the solution to ensure future therapeutics are readily available and affordable. It is important we continue to invest to promote innovation and de-risk processes and technologies, and ensure we bring the right partnerships together to deliver the medicines needed in the most efficient manner.

Touchlight, CPI and Ipsen worked jointly to develop a cell free synthesis platform for therapeutic protein manufacture. The cell free platform process requires the addition of DNA (in this case in the form of dbDNA™), and offers benefits such as increased process development speed, flexibility in developing and screening multiple products, reduced time to clinical delivery, and generating a more agile, standardised product. The removal of whole cells from the process improves consistency and means no cell harvest and lysis requirement, thus increasing simplification, overall leading to a more cost effective, competitive commercial product.

These three companies brought unique organisational skills and capabilities to the project, and each took a more significant role at different timings of the project, but all were needed during the entirety of the project to ensure overall success. Touchlight’s role was from the onset, to deliver a dbDNATM vector suitable for closed and large scale manufacturing. CPI had the assets (both technology and skilled staff) to operate as a central function supporting partner activities in addition to developing a cell-free process suitable for manufacturing. Meanwhile, Ipsen transferred all the processes developed at CPI and Touchlight in house and applied them to the manufacture of a therapeutic candidate molecule.

The impact of collaboration

Throughout the project numerous scientific and technical challenges (including working restrictions imposed by COVID, and supply chain difficulties) were overcome, at each stage providing significant learnings for the consortia, and for the cell free expression community within the UK.

The project was successful in establishing a cell free process largely due to the partnership created by the organisations. Each company brought their own value. Individually they had distinct roles and responsibilities, but they also had a strong interest to work jointly and seek innovation to solve the development and manufacturing challenges. As non-direct competitors they were able to share expertise, at all organisational levels, which was of great value to all parties. The consortia also understood the need for governance and regular communication, and all partners were engaged at all stages of the project, not just during the timings when their individual deliverables were due for completion.

Results and Outcomes

An additional advantage created by the consortia was the cross fertilisation and development of junior scientists through site visits and tech transfer initiatives. Both Ipsen and Touchlight visited CPI to gain access and experience in high throughput technologies. The willingness to showcase technologies and develop staff across the partnership allowed the tech transfers to be led by junior team members. The upskilling of staff was a benefit with longevity, outliving the project and great value to all organisations in future ventures.

A further benefit with longevity was the vast learnings and knowledge transfer the project generated, and the applicability towards other processes (such as mRNA technology), which not only provided a direct impact to future partner projects, but also the wider medicines manufacturing community. Following key project milestones, Touchlight significantly invested team time and finance in further developing and scaling the processes identified in this program. This technical development further enhanced their service offering to clients across a range of applications. CPI were similarly able to build upon and leverage learnings from the project to give a strong foundation for their subsequent work in the Vaccines Taskforce working on mRNA vaccines.

The project has been truly collaborative, with all parties contributing to the overall success. The right partnership working towards a common goal, with openness, trust, support, governance, and communication will not only deliver for their project, but also generate much needed benefits for themselves and the sector.

David Gruber (Director of BioProcess Sciences, Ipsen) and Jon Extance (Director of Development, Touchlight) presented at the 18th Annual bioProcessUK Conference 2021, during the ‘Celebrating Collaborations’ session.

Laura Griffiths is Innovation Lead for the Innovate UK Medicines Manufacturing Challenge. To know more about the Medicines Manufacturing Challenge please click here.

If further information is required, please contact Laura on laura.griffiths@iuk.ukri.org