testing in the pharmaceutical industry
molecule bioanalysis there has been a big push to get users and vendors together to work on common data standards so that file formats can be synced,’ says Usansky, who adds that another level of complexity currently being faced in the pharmaceutical industry is created by the need to file, store and review the data transfer files. A further concern more specific to bioanalytical labs is incurred sample reanalysis, which is a way that companies have to analyse samples a second time in order to confirm the initial measurement. Usansky explains: ‘Tere’s a whole workflow associated with incurred sample reanalysis whereby it’s necessary to find the existing result and assays for a second time and then bring the results together to determine whether they confirm each other.’ Termo Fisher Scientific’s Watson LIMS
has a feature called Incurred Sample Reanalysis (ISR) which enables the precise workflow for doing this. Subjects can be identified by factors such as treatment, group and time points, and organised for reporting, selection and grouping analysis. Of course, as pharmaceutical companies recognise the benefits of entering into collaborations, comments Trish Meek, the issue becomes one of needing to integrate all the information from not only their internal labs, but also from CROs and academic partnerships. Data Manager, from Termo Fisher Scientific, enables users to pull in all the original raw data, captured both internally and externally, and examine the base line and all associated results. ‘Tis tightly integrated environment
allows lab managers to look at the lab as a whole so that if something comes up that’s out of specification the user doesn’t automatically assume it’s a failed batch; they can see the raw data and determine immediately that the sample should be re-run due to a failed injection or run,’ explains Meek. She adds that in addition to this interactive data review, the solutions have the ability to automate the process ensuring that at each step the soſtware guides users through the process in a compliant and scientifically-valid way. During the past few
years, there has been a certain level of upheaval within the pharmaceutical industry and the numerous mergers, acquisitions and redundancies have meant that the reality is companies are now trying to do more
with less. Trish Meek explains: ‘Where the industry used to have people who could fill in holes in the process and ensure everything ran smoothly, companies no longer have the staff to be able to deal with those inefficiencies. It’s of paramount importance that these businesses continue to manufacture quality products and do good science within the R&D phase, and so need to provide as automated a solution as possible. From an informatics perspective, that’s where we’re seeing a big push.’
Paperless is more One topic that oſten goes hand-in-hand with discussion of informatics is the move away from traditional paper records and towards electronic environments – the so-called paperless laboratory. Trish Meek comments the push towards having a paperless lab is a major focus
IT CAN BE
CHALLENGING TO ACHIEVE A SEAMLESS INTEGRATION OF LIMS AND ELN BUT THE BENEFITS CAN BE SUBSTANTIAL
that the company is seeing within the pharmaceutical and biotech industries. ‘At all the various stages, the industry is moving the science forward and we need to support all the new methods of testing, new instrumentation throughout the life cycle,’ she says. ‘Tat’s always been the case but this push towards a paperless lab, while it’s something that has come up every five years for the past two decades, is only now actually being realised. We’ve reached the point where the technology is there and the reality is that we can deliver a paperless solution.’ Elliot Abreu agrees that paperless
Further information
LabWare
www.labware.com
Thermo Fisher Scientific
www.thermofisher.com
Xyntek
www.xyntekinc.com
12 SCIENTIFIC COMPUTING WORLD
environments have been a popular topic of conversation for many years and he believes that it remains one of the main drivers in boosting efficiencies, however he isn’t as confident that the industry is at that stage. ‘If you look at some organisations within testing environments,’ he says, ‘they’re using forms and templates that are still being managed in Excel or customised macros that have
been developed in-house.’ Abreu continues by stating that while there is currently a major push to replace these platforms with electronic versions, the main reason paperless environments have yet to be fully achieved is due to the complexity and ambition of what ‘paperless lab’ actually means. According to Abreu, a further and
perhaps more fundamental challenge, is educating users on the benefits of these systems, and getting buy-in across the user community, while developing the process and user requirements. ‘Tere is a great deal of hesitation when it comes to adopting new technology, and we witnessed this with the introduction of ELNs,’ he says, adding that with the implementation of successful systems and buy-in from across the user community, more and more integrated informatics technologies will be embraced, hopefully resulting in a cultural change. Tough, as with any major change, a
certain level of caution is advisable. Nick Townsend, from LabWare, believes that anyone considering the implementation of these applications should tread carefully as there are a lot of mixed messages around regarding the roles of each. ‘Combining LIMS and ELN can deliver many business advantages; the issue is getting the functional balance and integration right between the two,’ he comments. ‘It can be challenging to achieve a truly seamless, bi-directional integration of LIMS and ELN but the benefits can be substantial.’ He adds that feedback from the market seems to indicate that it is increasingly considered unwise to try and deliver a comprehensive laboratory automation solution with only one of these applications, for example by ‘stretching’ the functionality of an ELN. In conclusion, Trish Meek has this to say:
‘Looking to the long term, I believe that in the next few years we will get to the point where informatics will be viewed more holistically and in terms of what a solution delivers, rather than categorising down into LIMS or ELN functionality. It’s about looking at the daily workflows of scientists, technicians and laboratory managers, and identifying the best possible solutions to address them.’
References and Sources [1]
Sheldon S. Leung; Joel Usansky; Robert Lynde;
Teingi Tway; Robert Hendricks; David Rusnak. Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process. AAPS Journal. 14(1):105- 12, 2012.
www.scientific-computing.com
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