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informatics for pharmaceuticals

development process and ending in quality control. Analytical labs are very much procedure-driven, and informatics solutions are designed to improve the speed and quality of the analytical processes, allowing scientists to become more productive. QC review, for example, consumes a lot of the time required until a batch can be released. If you look closer into this area of quality control, you see much of that time is devoted to documentation and data handling. The root cause of bottlenecks and delays is not having the appropriate informatics solutions in place. There are a plethora of systems in a lab


and each one can provide data in a different format to the rest. This information has to

he informatics needs in pharmaceutical industries start in R&D in terms of intellectual property, before going further into the

Thomas Schmidt, senior product manager for informatics at Waters

be archived and that often involves burning a DVD at the end of the day, but systems like the Waters NuGenesis SDMS platform help to harmonise the IT landscape in terms of capturing all information from each source and storing it in a common repository. In addition to the competitive pressures to have an effective lab operation, the regulatory burdens are becoming heavier and so companies need to look to informatics to support that efficiency and ensure the people working at the bench can comply with procedures and have a lower rate of defects in their work. If you think about the IT landscape, you have a LIMS or SAP on the one hand

Mike Partington, director of sales, Europe, ACD/Labs G

iven the highly-regulated nature of the pharmaceutical environment, informatics software tends to be strong on validation and

compliance. Electronic Laboratory Notebooks (ELNs) are quite often aimed at replacing the traditional laboratory paper notebook allowing chemists to record everything that happens, while laboratory information management systems (LIMS) typically utilise workflows and capture discrete data. Although ELNs and LIMS also include experimental details, they do not tend to contain spectral information other than through links with external data or embedded pictorial information. Adding knowledge extracted from analytical data together with including real spectra and chromatograms, spectrally searchable, is a need that is becoming more prevalent. In the past, when a chemist required

nuclear magnetic resonance (NMR) or mass spec work to be done, they would submit the sample to the expert who would then run it, process the data, interpret it and then return the information via a piece of paper. With increasing requirements for labs to become paperless environments that paper has now changed to a PDF often embedded in their ELN. This seems to work quite well even though this information is not searchable, but an increasing issue is that as pharmaceutical companies downsize, those experts don’t


necessarily have the time to do that interpretation, resulting in more of that part of the process being passed down to chemists. They are now in the position of having to interpret that data themselves, so any tools making that processing easier are extremely beneficial. Another area within informatics

involves the capturing of analytical data from instrumentation. To maximise the companies’ investment, this should be done as live, not static, information that can have value added through the application of advanced algorithms detailing the interaction with chemical structures. There are many systems available that will archive that data, or that provide users with a registration database, but not many that allow companies to capture this knowledge should that scientist leave or should one need to retrieve an impurity already identified earlier during the research process. Our new Spectrus architecture is going

one step deeper in the intimate link between analytical data, structural information and the resulting knowledge. Spectrus Processor, the first product we will be releasing in the line-up, will allow chemists to view the spectrum if the expert is still doing the processing, or in those increasingly common occasions where the chemist has to do the interpretation, provide them with the ability to easily process the data, attach structures and verify their findings.

(prescription and over the counter drugs, medical devices, etc.) can affect the health of individuals, product quality is a steadfast requirement; not just an option. Those in the pharmaceutical industry must be able to rapidly get their products to market, and manufacture them in a highly efficient manner for the short window prior to generic alternatives being available. Regulations have increased around


the world at the same time that pressures to reduce drug costs have risen. Pharmaceuticals are seeing their costs increase, and their revenue decrease, and the combination of emerging markets worldwide with increased operating costs and decreasing revenues in the EU, US, and JP markets will drive a lot of companies to expand their operations globally. The pharmaceutical industry needs to

consolidate disparate laboratory informatics solutions into a single, centralised solution. With our ELN and SDMS tools, our clients are able to increase their ability to achieve their right-first- time goals on their testing results. This is achieved through reduction in data entry by instrument integration, and through automated data collection and consolidation.

and instrument software on the other. The problem becomes how to exchange information in a convenient and precise way. Between three and five per cent of manual transcriptions are erroneous, so you can see the potential for having an electronic system. There are a lot of initiatives driving the migration to paperless labs and we are increasingly seeing pharmaceutical companies adopt a platform approach that can be used in every area of the supply chain.

Jay Ross, senior product manager – quality manufacturing, Starlims

he pharmaceutical industry is faced with more compliance requirements than any other manufacturing industry. Since their products

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