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On the cutting edge
Looking at recent news of technological advancements potentially impacting the pharma and biotech realm, one story that stood out was an announcement that Bothell, Wash.-based BioLife Solutions Inc. has embedded its CryoStor freeze media into the manufacturing process for HepaStem, a cell-based treatment developed by Mont-Saint-Guibert, Belgium-based Promethera Biosciences that targets such disorders as hemophilia, acute or chronic liver failure, liver fibrosis and nonalcoholic steatohepatitis.
BioLife is a developer, manufacturer and marketer of proprietary clinical-grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud-hosted biologistics cold chain management app for smart shippers. Promethera’s technology platform is based on a newly discovered cell type, isolated from normal human adult liver tissue: heterologous human adult liver-derived progenitor cells.
“BioLife’s clinical-grade cell freeze media has been validated by our team and shown to enable high cell recovery and viability following the manufacturing process, providing at least two years of frozen storage of HepaStem,” said Patrick Stragier, vice president of operations at Promethera. “The use of CryoStor will enable global distribution of this potentially lifesaving cellular therapy.”
BioLife President and CEO Mike Rice added, “We are very pleased to support Promethera in their mission to develop effective cell-based therapies for liver disorders. Our CryoStor freeze media is broadly adopted by the drug discovery and regenerative medicine markets to protect various liver-derived cells during cryopreservation, which enables long-term storage and worldwide distribution.”
CryoStor and HypoThermosol, BioLife’s cell and tissue storage and shipping media, are now incorporated into more than 220 customer preclinical validations and clinical trials of cell-based therapies targeting blood cancers, solid tumors, vision loss, heart disease, stroke and movement disorders.
PANalytical launches Empyrean Nano edition
ALMELO, Netherlands—At the Denver X-ray Conference 2016 in Rosemont, Ill., in August, PANalytical announced the Empyrean Nano edition, a new hybrid laboratory instrument that offers a unique combination of various advanced X-ray scattering techniques. Researchers reportedly can deduce valuable information about nanoscale structures and dimensions and about order and disorder on the atomic level from the angular dependence of the scattering intensities that are measured from a sample under investigation. The information that is gained from such scattering experiments can often be correlated with the material’s behavior and application properties. Due to its good sensitivity even for very weakly scattering samples, the instrument is said to be well suited for the bio-SAXS application, a tool in structural biology and biological drug development for the analysis of protein molecules in dilute solution.
To ensure maximum flexibility the Empyrean Nano edition is based on the same goniometer platform and on the same concept of prealigned X-ray modules as is the PANalytical’s existing X-ray diffraction platform. For SAXS experiments the detector is usually kept stationary, but for complementary measurements at higher angles the detector mounted on the 2theta arm of the goniometer can be scanned around the sample.
Improving literature monitoring for pharmacovigilance
NEW YORK—Mid-September saw Elsevier, a provider of scientific, technical and medical information products and services, announce that it had updated its pharmacovigilance (PV) portfolio with the launch of QUOSA PV. This new version of Elsevier’s QUOSA literature management solution is specifically designed for the monitoring and review of scientific literature for adverse drug events.
QUOSA PV, developed by PV experts for PV experts, is a tool that organizes and automates the monitoring and triaging of articles and other forms of literature in a scalable environment. It is expected to help PV groups address patient safety, ensure transparency, maintain compliance with regulatory guidelines and improve the efficiency of the literature screening workflow. QUOSA PV, which also supports the EMA’s Medical Literature Monitoring (MLM) program, reportedly delivers a user-friendly, browser-based interface, empowering rapid, transparent literature surveillance and case triage and, in addition, is qualified to operate in a Good Practice-regulated environment.
Calorimetry and collaboration
MALVERN, U.K.—This fall has or will see leading microcalorimetry experts from across the globe joining Malvern MicroCal scientists at open-forum meetings in Europe and the United States that provide a valuable opportunity for scientists to extend their understanding and application of this powerful analytical technique.
Microcalorimetry enables detailed investigation of the interactions between and thermodynamics of molecules/biomolecules and is particularly widely used in the development and manufacture of biopharmaceuticals. The Second Annual European MicroCal meeting—co-organized by Malvern Instruments, Institut Pasteur and ARBRE European Molecular Biophysics Network—took place Sept. 26-27 at the Institut Pasteur in Paris. The other locations and dates on the heels of that event are San Diego on Oct. 18 and Cambridge, Mass., on Oct. 27.
“The success of last year’s inaugural European meeting demonstrated the demand for practical information on how to best to apply microcalorimetry and maximize the value of the data gathered,” said Natalia Markova, a principal scientist at Malvern Instruments. “This year we have an increased focus on best practices and data analysis, and on proven solutions that address traditional limitations to microcalorimetry and help users efficiently progress critical protein and biomolecular studies. We’re excited to welcome beginners and experts alike to Paris and to our meetings in the U.S., to share the latest advances in these powerful technologies.”
All three meetings were to provide insight into the latest developments and applications for both isothermal titration calorimetry and differential scanning calorimetry, as well as advice on best practices and advanced data analysis.
In recent years, the use of microcalorimetry techniques for the study of biomolecular thermal stability, biosimilarity and protein higher order structure, as well as binding affinity and interactions, has grown significantly, resulting in an increase in demand for microcalorimeters that provide outstanding data quality along with real ease of use, which Malvern maintains that its MicroCal range of microcalorimeters provides.
Automating the extraction of DNA, RNA and proteins
BASEL, Switzerland—The Thermo Scientific KingFisher Presto sample purification system made its debut at MipTec 2016, the International Life Science Exhibition, held in September in Basel, Switzerland. The KingFisher Presto system is designed to be part of an automated workflow using a liquid handler with a gripper or robot arm to purify samples with volumes from 50µL to 5mL. The instrument’s small footprint allows for easy connection to several liquid-handling instruments in either a side-by-side or on-deck configuration, allowing flexible selection of platform and use for a wide variety of applications.
Stackable, polypropylene KingFisher plates and tip combs are designed to be placed by a robotic arm and suitable for many biological applications, including projects that require a sterile environment.
“Built for high-throughput, highly automated labs requiring a robust, easy-to-use solution, the KingFisher Presto system provides reliable purification of DNA, RNA and proteins,” said Ray Mercier, vice president and general manager of liquid-handling consumables at Thermo Fisher Scientific. “An extension of trusted KingFisher technology, the system uses magnetic particle technology to integrate seamlessly into a variety of workflows, which greatly reduces hands-on time, saving lab resources and money.”
Saphetor signs agreement to deploy its platform for advanced NGS analysis
LAUSANNE, Switzerland—Saphetor, a company engaged in genome-scale analysis based on next-generation sequencing (NGS), announced recently that it had signed an agreement with the Geneva University Hospitals (HUG) to supply its Division of Genetic Medicine, headed by Prof. Stylianos E. Antonarakis—who is also director of the Department of Genetic Medicine and Development at the University of Geneva Faculty of Medicine, director of the iGE3 institute of Genetics and Genomics, and president of the Human Genome Organization—with comprehensive and accurate analysis of their NGS data. Under the agreement, Antonarakis’ team will apply Saphetor’s precision medicine platform for clinical use. HUG has chosen to install Saphetor’s software and data solution in-house.
“In our Genome Clinic we handle an ever-increasing number of cases that require processing of enormous amounts of high-throughput sequencing data to discover pathogenic variants in hereditary disorders and cancer,” Antonarakis said. “Saphetor’s sophisticated algorithms mine billions of data points and present the result in an easy-to-navigate interface that assists us to reliably and accurately diagnose and treat patients.”
Saphetor develops software and sophisticated analytical processes to identify genetic variants with greater accuracy and to give its clients access to seamlessly integrated data from a rapidly growing collection of genetic databases. To date, Saphetor has already aggregated more than 18 billion genetic variant annotations from a wide range of databases.
End-to-end solutions to automate NGS data analysis
ST. LOUIS—Appistry, a provider of solutions that simplify the analysis of NGS data, announced recently integrated solutions that automate NGS workflows to help clinical labs reduce the barrier of entry and costs associated with NGS-based testing. Expanding on Appistry’s current NGS analysis offering, the end-to-end solution features new interpretation capabilities within GenomeNavigator and leverages the genomics workflow platform from GenomePilot to automate the entire process from reads to report.
“One of the biggest challenges for a lab running NGS-based tests, or one looking to start, is the barrier of entry and costs associated with analyzing the sequencing data,” said Kevin Haar, CEO of Appistry. “We have found lab directors require more than the disparate bioinformatics platforms and interpretation tools available on the market today. Instead of addressing pieces of the workflow, our goal is to enable the automation of the entire workflow, providing an easier path for labs to establish or expand their NGS testing capabilities and improve productivity and costs.”
Appistry’s GenomePilot will automate the execution of NGS tests from the lab’s sequencer through the identification, qualification and prioritization of variants. Each case is presented in GenomeNavigator for first review, where a molecular pathologist can either approve the prioritized variants for clinical reporting, or in more complex cases, conduct further investigation using GenomeNavigator’s interactive interpretation environment.