Big Blue aims to modernise pharma production
architecture that promises to modernise the pharmaceutical
industry's manufacturing processes, often accused of lagging behind
those of other industries such as chemicals and foods, reports
Phil Taylor.
The company has teamed up with technology providers to develop a system of software and components that its says conforms to the US Food and Drug Administration's recent pronouncements on Process Analytical Technology (PAT) and Good Manufacturing Practice (GMP), specifically Science of Design and Manufacturing Science principles.
The move takes IBM and its partners firmly into territory currently occupied by the likes of Emerson Process Management and Honeywell.
IBM claims that the top 30 pharma companies can protect up to $60bn (€48bn) of future revenues, accelerate time to peak sales by two years and reduce Cost of Goods Sold (COGS) by up to 16 per cent by managing risk and applying scientific- and systems-based approaches throughout development and manufacturing.
Few would argue that there is no need to improve matters. In 2002, the drug industry spent $90 billion on manufacturing, significantly more than its total budget for researching new drugs, according to the FDA, and there is no suggestion that the situation has improved since then.
Meanwhile, data compiled by PricewaterhouseCoopers suggests that the pharmaceutical industry often runs plants at 15 per cent or less capacity, accepts that between five and 10 per cent of production will need to be scrapped or reworked, and that quality control takes up more than 20 per cent of total production costs.
IBM says its Proof of Concept (PoC) system provides a "framework to help take [companies] to the end state of higher production efficiency, lower operational costs, and effective regulatory compliance," according to Steve Arlington, global pharmaceutical industry leader at IBM Business Consulting Services.
"The business transformation is highly complex, and the route map of activities and changes an organization needs to take is not always clear," he added.
The shift towards PAT - which allows companies to monitor their manufacturing processes continuously and automatically in real time, rather than intermittently and historically via samples and post-manufacturing quality controls - is gaining momentum, according to IBM. PAT improves manufacturing quality and saves money, because it is cheaper to adjust a production line immediately than to discard goods that have fallen outside the agreed tolerances.
So far, the project has brought together IBM, Rockwell Automation and SAP, while other companies may also come on board. IBM and Rockwell have been collaborating on systems for manufacturing processes since 2002, while the IT giant's relations with SAP stretch back to 1989.
