LABORATORY INFORMATICS GUIDE 2015 | INTEGRATION ➤


connections between systems. She echoed Denny-Gouldson’s point: if quality data is getting to the process management system in real time, ‘it can change the process conditions by which they are manufacturing the product’. If there is a deviation from the standard conditions: ‘They might want to change the temperature and pressure in the manufacturing process to address the quality data and get the process back under control – if you do not get the quality data in real- time, then you are getting that data too late to impact change in your business.’ She continued: ‘It’s an easy vision for upper


management. If the quality data is connecting to my ERP then I know immediately if a product is out of specification and I can stop product going out the door or I can, hopefully, get my process under control in time, so that I do not even finish the process in that way but change the parameters and save the product.’ And, according to Shah, a seamless flow


of data allows for real-time reporting, via a dashboard, to senior management in an organisation. ‘If you do all the other things, one of the benefits you get is the ability to get flexible reports in real time of what data is important to you – at your fingertips,’ and the ability to present information on a dashboard in this way was a feature of Integration Manager.


There is one further driver towards the


paperless laboratory, Shah pointed out, and it is perhaps an unexpected one: ‘The Cloud is now becoming a big factor in people’s thinking and planning. It’s obvious that you are not going to be able to take things to the cloud on pieces of paper. That is going to make organisations keep all their data electronic and connected.’


CHANGING THE LABORATORY One aspect of integration that is sometimes overlooked amid the discussion of getting the process side of operations connected up, she pointed out, was integration within the laboratory itself: ‘One of the things people have been surprised by is in-laboratory integration – driving for real laboratory process integration.’ She spoke of how she had visited laboratories where something as simple as the balance was not integrated but this proved to be ‘a huge bottleneck in the process and was really slowing down the upload of that data into the LIMS, and thereby that data going into the process and being actionable within the organisation.’ In the pharmaceutical industry, Quality


by Design has been encouraged by the US Food and Drug Administration but, she said: ‘Those kinds of principles already existed in the other industries that we deal with. In-line


Biologics production reliant on analytical sciences


Biologics – which includes large molecules and antibody drug conjugates – are developed in a similar way to small molecules, but the production mechanism relies on living organisms. ‘You have to express the protein using a biological system,’ IDBS’ Denny-Gouldson said. A decade ago, only five per cent of


medicines were biologics but predictions now are that up to 80 per cent of the world’s drugs will one day be biologics of some sort. There are four stages in developing the


production process and they all need to be optimised together. First molecular biology and cell biology has to be deployed by the cell-line development group to optimise the cell line and the production of the material using that biological system. ‘There is a lot of structured data that needs to be captured,’ Denny-Gouldson remarked – a need not only to track what


10 | www.scientific-computing.com/lig2015


has been put into that biological system but also how that is to be scaled up. ‘The next group says “I need to run that


on a very large scale”. A lot of things that the cell biology guys do is optimise the construct to work at different scales.’ The next stage is to optimise the scale up


to 1,000-litre or 10,000-litre fermenters. To do this effectively requires real-time data capture from the fermenter. ‘Not just one or two variables,’ Denny-


Gouldson continued, ‘They’re capturing hundreds of different measurements in very small time spaces. Maybe every second, they take a reading from 300 or 400 different probes and they are measuring the pH of the media, the adhesion of the cells, the temperature, the nutrients and micronutrients in the media, and looking at how the production and the purification of the product is affected by all these different parameters.’


Because biologics production is a


continuous process rather than being done in batches, ‘The monitoring of these things is absolutely critical and the understanding of what changes affects your downstream elements, such a purity and viral loads, are very important.’ The next step, he explained, ‘is when you


pull in your purification guys. Howsoever the material is produced, I need to be able to take that and purify it until it is safe to use. ‘You have to measure all sorts of elements


and that it is continuous production makes that complicated. The final part, that runs across all of this, is analytical sciences – the ability to test samples and get results and understand the system from an analytical point of view. ‘These need to be developed and used


pretty much in real time and to check is the system running as it should do.’


and laboratory data goes hand in hand to the understanding of your final product and to making sure everything is running smoothly in the process.’ Nonetheless, according to Denny-Gouldson,


the role of the analytical laboratory and the analyst are changing. Rather than being a service where samples are created, sent off, and then checked into the laboratory, nowadays: ‘They are intrinsically integrated into the process. In real time, as much as possible.’ And in an echo of Meek’s point about improving processes within the laboratory, he said that IDBS had been witnessing the


According to Shah, a seamless flow of data allows for real-time


reporting, via a dashboard, to senior management in an organisation


increasing use of robotics and automation in its customers’ laboratories. For Denny- Gouldson, too, the aim is, as much as possible, to work with the systems that customers already have in place. ‘We don’t say to people get rid of everything and start new. With BPES (Bioprocess Execution System), we are putting a layer over the top of those current investments and infrastructures like LIMS and


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