LABORATORY INFORMATICS GUIDE 2015 | INTEGRATION
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the analytical data management infrastructure. The bit we are adding is the data management around the process. We are changing the way they can access that information and the way in which they collect that and optimise their process. The IT is the easy part, he continued;
change is where it gets difficult. ‘What we provide is that foundation layer that allows organisations to develop in steps. You cannot do this as a big bang; it has to be iterative so the organisation can manage the change effectively. Once in place, our system allows people to optimise their process much more easily than in a paper or Excel-based system. They can apply their process knowledge more effectively to get to quality by design – you design in the quality because you know so much about the system you are running.’
FLEXIBILITY One outcome of integration is greater flexibility and less rigid standard operating procedures, he said. Managers have more flexibility to react to deviations from the specifications of the process conditions. Quality by Design is the goal of all these
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organisations whether big pharma themselves or contract manufacturing companies. Because the biologics environment is so
much more complicated that small molecule manufacturing, according to Denny-Gouldson the BPES allows managers to use a risk-based approach: ‘It collects much more data and thus allows them to go back and do that sort
Quality by Design is the goal of all these organisations whether big pharma themselves or contract manufacturing companies
of analysis where they can ask: “Do we know what happens and can we let the system flex?” rather than saying “No, we’ve got to throw it all away and start again”.’ IDBS has found that the BPES, developed
largely in response to the pharmaceutical industry’s move to biologics rather than small molecular drugs and by its interest in Quality by Design, is also applicable – directly so – in one significant area of the petrochemicals industry: biofuels. Biofuels, of course use the same sorts of biological systems – fermenters
and the like – to produce bioethanol, so with an understanding already gained of biologics, IDBS can apply its technology very quickly. But because so many of the processes
in the wider oil and gas industry are continuous, according to Denny-Gouldson the applicability of the principles developed with BPES range far beyond biofuels: ‘We’re now working with a number of process chemical, and oil and gas, customers and providing a very similar approach – where you have to understand your process; you have to understand your data; and how you get that data. ‘It’s not about running the plant and getting
analytical data – you’ve got to optimise that process. They have really latched on to that concept with us.’ It is the underlying approach that is
applicable, in other words. And the effect can be massive. Given the massive volumes that flow
through oil and gas plants, Denny-Gouldson remarked, even a one per cent improvement, resulting from the optimising of the process ‘can translate into hundreds of millions of dollars over a year’. l
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