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This shows the complete history of the sampling cycle Today’s clinical genomics and bio-pharmaceutical research laboratories and contract research organizations are increasingly challenged by enormous amounts of data, they need to manage, process and interpret, often in a highly regulated environment. Advanced scientific data management solutions optimize workflows, increase output and enable instrument and data connectivity within and between lab organizations in a compliant way, says Nicole Rose, responsible for Product Applications, Digital Science at Thermo Fisher Scientific.

Particularly industry companies in their growth stage - let’s say the clinical genomics start-ups - produce huge amounts of data, when using for example next generation sequence techniques and likewise and also face strict regulatory compliance requirements.

On Friday March 22, 2019, the Matrix VII building in Amsterdam Science Park was officially opened. This vibration free office-cum-lab houses various companies, including the Advanced Research Center for Nanolithography (ARCNL), a ‘triple helix’ cooperative between NWO, UvA, VU and ASML.*

The building was designed by a team consisting of Deerns, Ector Hoogstad Architects and IMd engineering consultancy. The hybrid office-lab building has more than 9,000 square meters of office space that is easily convertible into labs should the need arise.

I’ve actually written this column a little early, because the real Taco Day is celebrated on October 4. But hey, I can’t help the fact that there’s no LABinsights edition planned for that day. Besides, my topic today is bigger than just me. I’d like to call your attention to the importance of standardization in the widest sense of the word. As you may know, I am the 2019 Chairman of the Board of Directors of ASTM International. I consider it a great honor to represent more than 32,000 international volunteers.

Stringent dioxin regulations are causing quite a buzz in the European reference lab network Some of the world's leading research into dioxin analysis is happening at the University of Liège Faculty of Sciences, where Chemistry department head Jean-François Focant and his team are spearheading studies on dioxin testing using triple quad GC-MS. This method will enable labs to meet the stricter analytical standards the EU is set to impose. Triple quad GC-MS is used more and more to replace magnetic sector-mass spectrometry, which was the only authorized method for dioxin determinations until about five years ago. Even Focant's lab still uses these enormous machines. Their performance is excellent, but analysts need specialist knowledge to use them and they have a huge footprint. By contrast, a triple quad-mass spectrometer fits on a lab bench, costs half, is more user-friendly, and works just as well as magnetic sector MS. Focant’s research group has been working on triple quad analytical methods for years.

Janssen Pharmaceuticals outsources central management of 17,000 lab instruments Janssen Pharmaceuticals Beerse, a J&J subsidiary, has outsourced the maintenance of all its lab equipment. The decision has big advantages; the equipment’s maintenance status is clear, maintenance is more efficient, up-time is increased and costs are lower thanks to economies of scale with existing suppliers. But above all, outsourcing reduces the administrative workload for lab managers and analysts.

Not only has Beerse maintenance been outsourced, but also equipment from the Janssen-labs in Geel (raw materials production) and Merksem (clinical facility). After eighteen months and proven success, J&J is rolling this approach out to other European sites.

Rainer Schramm, owner and managing director of Fluxana GmbH, talking about XRF supplies In just 15 years, Fluxana has established a strong global presence. This German contract laboratory and manufacturer of lab supplies, calibration supplies and XRF sample preparation equipment now has a strong, worldwide position in an expanding niche market. Fluxana is based in Bedburg-Hau, near Kleve on Germany’s border with the Netherlands. Its brand-new headquarters house labs, an R&D department, of ces and a spacious lab supply storehouse. Everything is geared toward X-ray fuorescent spectrometry, known in Germany as RFA, abbreviated from Röntgenfuoreszenzanalytik.

Protection level determines choice of gloves How safe are gloves that protect the wearer’s hands for less than a second upon contact with a solvent? And how safe are gloves made of a material that migrates to the skin and harms the wearer’s health? SHE officers are starting to realize that not all gloves are created equal. At the Laborama safety seminar in Spring 2017, Ann Van den Borre, Senior Technical Manager and Guardian Chemical at Ansell HealthCare Europe, pointed out that many analysts do not know enough about the responsible use of safety gloves. The protection gloves offer against chemicals depends on their thickness and the type of material they are made of. Lab technicians usually wear disposable latex or vinyl gloves because these offer touch sensitivity. What few technicians know is that these gloves only provide splash protection. Once fouled, a vinyl or latex glove should be replaced immediately.

University of Münster’s new plant research chambers provide prime research conditions The University of Münster (WWU) in Westphalia, Germany recently commissioned six special plant research chambers to facilitate its molecular genetic and cell biology re- search. These state-of-the-art facilities put the Institut für Biologie und Biotechnologie der Pflanzen at the forefront of Germany’s plant research community. With the new plant research chambers, the biology institute’s research facilities have effectively tripled in size to six 12 m2 rooms. The old facilities, some of which dated back to the 1960s, were badly in need of replacement. They were cramped, and the environmental controls were outdated and unsuited to the precision standards required for today’s plant genetics re- search. Stefan Weinl, a researcher at the WWU’s Plant Molecular Genetics and Cell Biology research group, praises the new chambers. “These new research facilities will allow us to make strides in our studies of Arabidopsis, our main research project. We’re trying to take what we learn from this model plant and transfer it to commercial crops. This is fundamental research.

Franz Walt, President of Laboratory Diagnostics at Siemens Healthineers User-friendliness: every major lab equipment supplier knows it is the number one priority in product development. Franz Walt, President of Laboratory Diagnostics at Siemens Healthineers, explains how his company puts customers first. Siemens Healthineers developed ‘Atellica Solution’ after asking hundreds of clinical laboratory specialists and end users what they expected from a new generation of automated immunoassay and chemical analyzers. This study, conducted by an independent market research firm, was the basis of a multi-year R&D project. Siemens created a dedicated advisory board composed of lab specialists and asked them to evaluate the company’s technological innovations. The board’s feedback determined the project’s direction. “We flew in these professionals from all over the globe. My roots are in the pharmaceutical industry, so my thinking wasn’t sales-oriented, but based on needs, which is how you have to think when you’re developing drugs.

Integrating platforms accelerates QbD continual improvement initiatives It is time to put more emphasis on the preventing facet and re-order the sequence of the CAPA abbreviation into PACA. We now can turn our potential data graveyards into valuable resources to facilitate the QbD promise across the pharmaceutical Quality System model. It is proven that his theory to adopt continuous improvement strategies to decrease variability resulted in significantly better products and financial performance.

A modern, largely robotized laboratory that connects departments and processes sample material quickly, safely and accurately according to standardized procedures. Too good to be true? It is already operational at the Leiden University Medical Center (LUMC). The current generation of robots is compliant and made to help people. With that in mind, the LUMC has been working for years on a core lab that is sophisticated, well equipped and, moreover, future-proof. This was not an easy task because several laboratories had to be merged. And, on top of that, it was also necessary to redesign the diagnostic process and the laboratory information system (LIS), standardize the method and develop a new quality system.