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informatics for pharmaceuticals


Trish Meek, director of product strategy for life sciences, Thermo Fisher Scientific


F


or many years, pharmaceutical laboratories operated in disparate silos, meaning that the bioanalytical group was separate from R&D


and manufacturing. While these groups interacted in terms of the overall process, they functioned in isolation. We are now seeing organisations wanting to view their operations in a holistic fashion and are taking a more integrated approach. Outsourcing is an increasingly


prominent trend and informatics solutions need the ability to manage the workflow between the pharma sponsor and contract research organisation (CRO). Instead of working within their organisations, pharma is now a conglomeration moving towards a common goal, and Thermo Scientific Watson LIMS allows users to design a study, send it to the CRO to execute, and then import data back. Web service enablement is a key component of creating that integrated lab environment and Microsoft SharePoint is increasingly being used as it provides a buffer between organisations while acting as a collaborative portal. From a manufacturing perspective, we’ve


seen a focus on streamlining processes. The questions being raised are how to take


what we have learned from critical process parameters, and the critical quality attributes of products, and marry the two to ensure companies are running the best possible process? This changes the way we define specifications. For example, instead of saying the batch temperature needs to be between 20 and 30 Celsius during manufacturing, you examine all the parameters and identify a design space where drugs can be manufactured successfully. Making these definitions is changing the


way we use informatics. These solutions have gone beyond being seen as something put in a laboratory to help run things – they are now about driving businesses forward and enabling scientists to make faster, more informed decisions. The huge amounts of data must be available to decision makers in the form of useful information. Initiatives such as Quality by Design (QbD) improve productivity by streamlining production, cutting inventories, reducing rework, and improving business process integration.


Tom Curtis, VP of product innovation at Labtronics


T


he laboratory ecosystem can be considered to be all of the activities, instrumentation, and personnel involved in the processes and


procedures that occur in the lab environment. In that ecosystem, questions such as whether the analysts have been fully trained, if the reagents are qualified to be used, and if the instruments have been calibrated properly all need to be answered before and during any procedure or analysis. Historically this information has been gathered and documented manually, and may be difficult to access. As a result, procedures have required a high degree of review to verify that each step had been done correctly. To support this ecosystem properly,


informatics solutions need to incorporate a high level of real-time integration between all of the elements. This establishes a ‘right first time’ environment where the lab can be confident that processes and analyses have been conducted as required. Integrated,


18 SCIENTIFIC COMPUTING WORLD


real-time sharing of information within the informatics systems provides assurance about how the work was performed and provides quick access to information. Analyses often include a range of


different activities to identify components for a sample. While there may be centralised system to store the results, a significant effort is required to bring all of the different sources of information and data together. In an integrated environment, such as Nexxis iLAB, users have access to all the required information at the bench level – at the time of analysis. This allows checks and balances to be applied in real time, increasing the quality of the work. The concept is a relatively simple one and it is certainly the direction that we see the pharmaceutical market taking.


Peter Maier, director of marketing and sales at iCD. Vertriebs


O


ver the past 25 years, the


situation within the Laboratory Information Management Systems


(LIMS) market has changed considerably, especially in terms of functionality. LIMS have traditionally consisted of a small core that was built on according to user requirements, but we have moved on from that. We have added many workflows from our customers directly into our core so that the software now includes all the functions needed for doing laboratory work spanning from R&D, IPC, QA/AC, through safety monitoring and environmental control.


WE HAVE ADDED MANY WORKFLOWS FROM OUR


CUSTOMERS DIRECTLY INTO OUR CORE SO THAT THE SOFTWARE NOW INCLUDES ALL THE


FUNCTIONS NEEDED FOR DOING LABORATORY WORK


One important thing that has changed is that managers don’t want to hear the term ‘LIMS’ any more. The reason for this is simply that a large company may have to pay millions of euros to have unlimited use of SAP within the enterprise and the top pharmaceutical companies more or less all run SAP/QM. The QM module itself is known as LIMS inside SAP, and it has effectively replaced standalone LIMS in many international companies. Companies are therefore asking why they should pay for a LIMS when they are already using the QM. This module does come with restrictions however, that mean users can’t interface with instruments in the lab. Our SAP Middleware, Labs/QM, solves this problem by bridging the gap between the two.


www.scientific-computing.com


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