A new collaborative model linking companies, academia and government should save the pharmaceutical industry millions and help smaller firms in Britain reorientate to supply the pharma manufacturing of tomorrow.
Had you asked GlaxoSmithKline, AstraZeneca and Novartis a few years ago to cuddle up, share manufacturing processes and collaborate on new ones, you might have been given one of their stronger tablets and told to lie down.
But decades of inertia in reforming the manufacturing supply chain and huge amounts of wasted stock have caused big pharma in the UK to ‘open their kimonos’.
Globally the pharmaceutical industry has spent, arguably wasted, over £1 billion on developing continuous manufacturing processes in silos, and in wasted drug stock. That’s the verdict of Dr Clive Badman, a 35-year pharma industry veteran and leader of “CMAC”, a collaborative group that is helping to restructure the way drugs are manufactured.
The driver is the realisation that much of the processes big pharma companies have spent millions on – more than £100 million per company – in developing continuous manufacturing could be shared without losing any competitive advantage to one another.
With a background running Investigative Materials Supply at GSK, despite partial retirement in October Dr Badman will now develop his supply chain work into “pre-competitive collaboration” for the group. The project shares knowledge of manufacturing processes to speed up time to market for a standardised, reliable continuous manufacturing process.
The Engineering & Physical Sciences Research Council, or EPSRC, has developed 16 CIMs, or Centres for Innovative Manufacturing. A centre is virtual, comprising a group of universities and industrial partners that are focused on achieving a common specific goal or goals.
“This model… gives us a chance to look at some of the fundamental issues that are preventing us from introducing continuous manufacturing into the pharmaceutical industry” Dr Clive Badman, GSK
The EPSRC CIM for Continuous Manufacturing and Crystallisation, or CMAC, which Dr Badman chairs, is hosted by the University of Strathclyde and involves six other universities with strong departments in pharma manufacturing. There are three tier one “end-users”, and industrial suppliers of manufacturing & measurement equipment, and control systems.
The industry-academia-government model, “gives us a chance to look at some of the fundamental issues that are preventing us from introducing continuous manufacturing into the pharmaceutical industry,” says Dr Badman. CMAC has a healthy budget of £60 million and 81 full-time staff. A new technology innovation centre will be opened in 2014 at Strathclyde to give CMAC a physical base and more research power.
Stealing the model from the aerospace industry via a colleague, Professor Sir Jim McDonald, who observed how “big aero” firms like Roll-Royce and Boeing were collaborating, pre-competitive collaboration is needed because it is “almost too expensive to do this individually.” Now, Badman wants to collaborate further with the Massachusetts Institute of Technology and European universities.
What about IP? Surely Novartis doesn’t roll onto its back and let arch rival AstraZeneca pick up and finetune a process it’s spent 10-years and several 10s of millions of pounds not getting right. Not quite… but kind of.
“We are not sharing any details on molecules,” Badman alludes to the vital IP. “But we want to work together on introducing continuous manufacturing and other technologies that go with that. Will we share everything? No.” He adds: “If I [alone] try to develop a particular molecule with continuous manufacturing it may give me a small benefit on cost. But it’s not going to be enough to outweigh the existing capital and facilities companies have often sitting empty around the world.”
Waste, in legacy infrastructure for example, is one driver for this collaboration. There is a huge, unwieldy infrastructure for making and storing pharmaceuticals around the world that almost prevents any new technology being adopted. “The industry is operating between about 3 and 4-sigma in manufacturing, so there is a big cost of quality associated with manufacturing and the inventory we have tied up,” says Badman.
Surely Novartis doesn’t roll onto its back and let arch-rival AstraZeneca pick up and finetune a process it has spent 10-years and several 10s of millions of pounds not perfecting? Not quite, but kind of.
GSK is now leading a bid for Round 4 of the Advanced Manufacturing Supply Chain Initiative, with partners AstraZeneca, the IfM at Cambridge University and several supply companies.
“If we want to deliver personalised medicine, or medicine to low population density areas, will we use the same supply chains we currently have?” asks Badman. The work this four-year AMSCI bid will show what capabilities suppliers must have to offer a service to the pharmaceutical manufacture of the future.
Such knowledge should put domestic UK companies in a better place to work with primes like GSK, says Badman.
Dr Badman spoke to Will Stirling at Manufacturing the Future, the national conference of the EPSRC Centres for Innovative Manufacturing.