In November 2012, a TSB report identified that the UK is slipping on biologics and needed to act to regain the leading edge. There was also a need expressed by SMEs for labs and pilot plants for new research products. Fit for purpose regulation is required.
Fewer and fewer small molecules are being approved, however there is a lot of repurposing of old molecules, as technology has lowered the bar to entry. Cocktails of small molecules and pharmaceuticals based on plants are being used, starting with the plant molecule and then tweaking it.
Not enough skilled people vs. more and better Jobs.
The National Biologics Centre at Darlington intends to address:
- the application of innovative process technology and new manufacturing routes for existing biologics (biopharma and biosimilars).
- determining manufacturing routes and process technologies for the next generation of biologics.
- improved finish and fill technology for both existing and new biologics.
- enhanced molecular characterisation and testing technology including in process analysis and control.
- challenging current facility design with a view towards the factory of the future.
- workforce and skills development and training – enough trained people quickly enough.
The selection of Darlington was from a short list of six sites, and the choice was driven by the fact that most pharma manufacturing in the UK – of which biologics is forming an ever-larger part – takes place in the North East. The region will benefit from the opportunities that arise through proximity.
Q: How far will biologics go?
Benefit of biologics is specificity, but this makes the market is smaller.
Q: It seems that the regulator is not keeping up with what is required for biologics. Will the National
Biologics Centre help the regulator?
Edward Twiddy, Director of the North East Local Enterprise Partnership (NELEP) and Ben Fisher Smart Specialisation
The questions of whether life sciences in the North East needed funding and, if so, what sort, were posed. Smart Specialisation is evidence-based, place-based funding.
Regions specialise in what they’re already good at. They’re helped in this by European funding disbursed through NELEP. Life sciences – including pharmaceuticals – are a strategically important industry for the North East, and NELEP will get behind excellence by fostering, supporting and energising. They must be supplied with the evidence of what is needed, however. NELEP has few employees, therefore information used to make finding decisions must come from business and other involved parties.