In Featured, Member News & Blogs, News, North East News

7 March 2016

Ian Shott provided an update on local and national events and priorities:

The Conservative government understands the value of biotech and pharma to the UK economy and its future growth.  Ruth McKernan, ex-Pfizer and the new head of Innovate UK has overseen IUK’s reshaping into five divisions, one of which is health and life sciences. IUK will continue to invest in the Cell Therapy Catapult and the new Precision Medicines and Medicines Discovery Catapults.  Ian didn’t quite say this, but we are catapulting UK Biotech into the world and the bioeconomy is our strength. Additionally there are national priorities that support continued investment in research councils and in the innovation system.

An update on the old Sanofi site at Fawdon, which was sold to Discovery Parks, is that that it is no longer intended for biotech follow-on space.  The whole site will now be used by one company, Accord, who will use it for generic pharma manufacture. This investment comes with a guaranteed minimum of 100 jobs. With luck this could rise up to the previous level of 400 jobs.

Ian’s new company http://arcinova.uk/ has been launched as a contract research and development company at what was the Covance site in Alnwick.

Steve Taylor of Fujifilm Diasynth provided some background to the Medicines Manufacturing Industry Partnership where he is involved at a national level.  A new Medicines Manufacturing Innovation Centre is planned, an API-focussed counterpart to the NBMC.  A partnership has been set up by CPI and the University of Strathclyde to develop the MMIC.  There was strong interest around the table in the idea that the planned MMIC should have a presence in the North East.

Martin Inskip gave us a progress report on the project to install and implement continuous processing of APIs at the MSD plant in Cramlington, ahead of the NEPIC event on the same topic.

Merck has been comparing sites in its manufacturing network and Cramlington has shown to be a plant that has kept costs low in both high volume and low volume manufacture. For these and other reasons, Cramlington has been chosen by MSD as the site of its first continuous manufacturing pilot.  The continuous processing systems will be online for API manufacture in first quarter of next year and martin and others are currently working to prove the concept.

This is a big investment by the company in the new systems. They will be available for all types of products, solid dose, APIs, biologics and handling everything including granulation, formulation, blending and coating.

The low volume, high value, shorter manufacturing cycles lead to a drop in inventories and thus reduce the need for working capital.  They can handle batches of variable sizes, so while the team is undertaking proof of concept they are able to do ten experiments in a day; learn more about the products; and carry out inline testing of product. Work in progress will lead to smaller manufacturing campaigns: continuous processing aligns well with lean principles. The advantage is versatility and reduced cycle time. There is less cleaning because the machines are much, much smaller and it is possible to pull out and replace units far more easily.

The business case is interesting. There is a rapid life cycle but it is not for all products. There remains the challenge of what the regulator will accept for validation. A critical feature is managing the people.

Tongue in cheek, Martin remarked that the Pharma industry has a long history in using technology to worsen productivity but the blockbuster model of pharma is dead. We have the human genome project and precision medicine to tailor and customise drugs. Innovation has slowed down but human population has increased. We need lower costs. Smaller volumes and better precision with continuous factors of cost reduction and productivity improvement. We are transforming technology to drive step change.

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