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On the cutting edge
May 2016
by Jeffrey Bouley  |  Email the author
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We didn’t bring you any May flowers, but how about new protein sequencers, cloud-based R&D, correlative Raman-SEM imaging, a newly compliant handheld Raman analyzer and cloud-based monitoring and analysis of clinical trials?
 
Protein sequencers offer enhanced sensitivity and better compliance
 
COLUMBIA, Md.—Shimadzu Scientific Instruments recently released the new PPSQ-51A single-reactor and PPSQ-53A triple-reactor protein sequencers. The new PPSQ-51A/53A protein sequencers employ Shimadzu’s SPD-M30A photodiode array detector for higher sensitivity. The detector features a capillary cell that is 8.5 times longer than standard cells, which increases sensitivity and enables the study of longer protein sequences.   
 
New PPSQ software can be configured to meet a laboratory’s needs whether it is regulated, research and development or academic. The software enables compliance with FDA 21 CFR Part 11 guidelines with regard to security, user management and audit trail requirements. Easy-to-use data analysis functions simplify operation, data processing and reporting. These functions allow the reprocessing of chromatograms, the overlaying of multiple chromatograms, chromatogram subtraction and automatic estimation of amino acid sequences. Additionally, the PPSQ-51A/53A sequencers provide customized reports and yield graph display for a quick and comprehensive view of data.
 
PPSQ series protein sequencers separate PTH-amino acids isocratically. Isocratic sequence analysis provides more stable retention times. That means peaks detected in previous cycles can be cancelled using chromatogram subtraction, Shimadzu says, making it easier for users to identify the correct amino acid. Performing PTH-amino acid analysis in isocratic mode also enables laboratories to reduce liquid waste and running costs through mobile phase recycling.
 
Cloud is ‘the future of R&D,’ says IDBS at Bio-IT World
 
BOSTON & LONDON—April 5, at the Bio IT World Conference & Expo 2016, IDBS signaled its commitment to delivering its enterprise research and development (R&D) platform in the cloud. The strategic move sees E-WorkBook, a leading R&D platform created by scientists for scientists, available via software-as-a-service (SaaS) for organizations globally. According to IDBS, the “agile, adaptable SaaS offering” supports growing laboratory demands for automation, collaboration and data sharing, as well as robust IP security.
 
“As the R&D landscape continues to change rapidly, labs are increasingly realizing the benefits the cloud can deliver, especially with regards to reducing costs and ensuring flexibility in an era of externalization and collaborative partnerships,” said Laurence Painell, vice president of product management and marketing at IDBS.
 
The company says it sees rapid adoption of cloud-based services by small and mid-tier pharmas, notes that the majority of large enterprise accounts are planning migration to IDBS-hosted cloud services over next three years and boasts that more than 50,000 researchers and 80 percent of the top 20 pharma firms worldwide now use IDBS software.
 
RISE correlative microscopy now compatible with ZEISS SEM
 
ULM, Germany—The WITec RISE microscopy mode for correlative Raman-SEM (scanning electron microscopy) imaging is now compatible with the scanning electron microscope ZEISS MERLIN. The new hybrid system was jointly developed by the two German microscope manufacturers, bringing together a wealth of expertise in Raman spectroscopic imaging and advanced ultrastructural analysis. Customers benefit from both high-quality and sophisticated system components for state-of-the-art research in the fields of nanotechnology, life sciences, geosciences, pharmaceutics, materials research and others. The first system of this kind was at the time of the announcement being installed at one of the largest research institutions in South Korea.
 
According to WITec, Raman microscopy—as a label-free, non-destructive technology for the identification and imaging of the molecular composition of a sample—is the perfect complement to SEM, which visualizes the surface structure of a sample, and the often-associated EDX (energy-dispersive X-ray spectroscopy) that can only identify elemental constituents.
 
The integration of both techniques into one system greatly improves ease of use and accelerates the experimental workflow. It places both the objective and sample stage required for Raman microscopy within the SEM’s vacuum chamber; thus, the sample can remain under vacuum for both measurements and is simply transferred between the Raman and SEM measuring positions by a software-driven push-button mechanism using an extremely precise scan stage.
 
“We believe that correlative RISE microscopy will be of immediate benefit in answering many scientific questions, with the integrated whole providing insight far greater than the sum of its already exceptional parts,” said Dr. Olaf Hollricher, CEO and director of R&D at WITec. “The development of RISE microscopy is another example of WITec’s innovative strength. It fulfills the promise of correlative microscopy for both the Raman as well as the SEM communities.”
 
The combined system provides all functions and features of a stand-alone ZEISS SEM and a WITec confocal Raman microscope.
 
Rigaku complies with new Raman calibration standards
 
WILMINGTON, Mass.—New regulations came into effect recently that set acceptable Raman wavelength shifts and associated tolerances for benchtop and handheld Raman instruments for pharmaceutical applications. Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is said to be fully compliant with the new calibration standards, which were published by the European Pharmacopeia in Supplement 8.7, Chapter 2.2.48 in October 2015. 
 
The need to manufacture pharmaceutical products faster and more safely combined with the pressure to reduce the costs and comply with rigorous regulatory requirements has contributed to the increasing adoption of handheld Raman for raw material identification, Rigaku notes. The rise in popularity of the technique resulted in the updates to the standards for acceptable tolerances for handheld Raman instrumentation to ensure a set industry standard for instrument performance.  In addition to the new tolerances for polystyrene, paracetamol and cyclohexane, appropriate calibration and system performance tests have also been outlined.
 
Unlike other handheld Raman analyzers, Progeny successfully overcomes sample-induced fluorescence interference with the use of a unique 1064nm excitation laser which also enables measurements to be taken through packaging. The device facilitates regulatory compliance by providing a complete IQ/OQ/PQ protocol package, compliant 21 CFR Part 11 digital signatures and an integrated camera for barcode reading to ensure error-free data entry.
 
“The introduction of the new regulations demonstrate the increased awareness and popularity of handheld Raman as a solution for rapid, accurate and reliable raw material identification,” commented Bree Allen, general manager and vice president of the Molecular business for Rigaku Analytical Devices. “We are committed to supporting our customers in ensuring compliance with the new standards as well as further educating the pharmaceutical industry on the benefits handheld Raman can deliver.”
 
BMS picks Medidata Clinical Cloud
 
NEW YORK—Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced in April that Bristol-Myers Squibb (BMS) has selected the Medidata Clinical Cloud to help manage, monitor and analyze its clinical trials. Medidata’s technology platform will support BMS’ research capabilities in immuno-oncology, oncology, immunoscience, virology, cardiovascular, fibrotic diseases, genetically modified diseases and metabolics.
 
The platform has been used by more than 630 customers around the world, supporting more than 11,000 clinical studies, 420,000 investigational sites and more than 3.1 million trial volunteers, Medidata notes, “driving a transformation in clinical trial design and execution, leading to better science and new medical breakthroughs for patients.”
 
BMS will integrate Medidata’s data management, data analytics and risk-based monitoring capabilities into all stages of its drug development process.
 
“Our agreement with Bristol-Myers Squibb is a great example of how the world’s best clinical researchers are increasingly relying on Medidata technology to help support advances in treatments for patients,” said Medidata’s CEO, Tarek Sherif. “Medidata has developed the most comprehensive cloud platform dedicated to clinical research, powered by the world’s largest data repository. With our powerful and flexible SaaS solution, we are helping our customers achieve meaningful time-to-market results, as well as giving them the data and actionable insights they need to innovate successfully.”
 
Code: E051630

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