Biologics Progress Update – May

It seems a long time since the intention to create a new innovation centre was announced in December 2012. For the team it feels like yesterday as we engaged on a series of stakeholder engagements to work out what the market needed and what was required to make the difference. Although the contract to deliver the project was only finalised and executed on Maundy Thursday, we have consulted over fifty companies, stakeholders either one to one or at the three workshops we have organised to date. We plan to run a further workshop for northern SMEs soon. We have consulted the MHRA, universities, discovery institutes and SME’s, CRO’s, CMO’s, larger companies, trade associations, equipment and technology suppliers, research trusts and the healthcare providers.

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Six clear challenges are emerging from the consultation which are:

  • New process technology and new routes for manufacture of existing biologics for enhanced robustness and lower cost of goods
  • New process equipment, process routes and technology for next generation biologics including testing and demonstration of new technology
  • Improved finish and fill capability for both existing and new biologics
  • Enhanced molecular characterisation and testing technology including in process analysis and control
  • Challenging and evolving facility design and operation
  • Workforce and skills development and training

We believe that the most effective way to work on these challenges will be to engage the existing centres of excellence to build a hub and spoke’ network of activity, with the hub as a new centre. Through the rest of the year we will define the spokes and determine how the hub and spokes will work together to deliver benefit for the partners and stakeholders. Since January the team has developed an indicative estimate for the capital build for the centre. In addition we have been validating the challenges listed above and developing the user requirement brief which will provide the capability to progress the challenges.

We hope that industry funding and other funding which will be sought as the project develops will significantly add to the public commitment, but it is clear that we cannot solve all of the problems at once. Over the next period, we will be working with the Health and Medicine KTN, industry, universities and other key stakeholders to develop and prioritise projects and programmes focused on delivering the challenges above; some will be dependent on the establishment of the new facility, but we hope we can start others much sooner by working with the spokes and other partners.

Regarding the selection of a site for the hub, we have been approached by many potential hosts, and have now shortlisted to five. All have been visited and we are now working with each to undertake a detailed analysis in order to make a final and reserve selection soon. On a parallel path we are working closely with eXmoor Pharma concepts LTD to develop a URB to enable us to then move forward for OJEU tender for the design and build which we hope to conclude in the next few weeks.

Finally with the guidance of the Technology Strategy Board we are assembling an Industry Steering Group to meet soon to check, guide and steer our activities to deliver best effect and value.