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On the cutting edge
June 2019
by Mel J. Yeates  |  Email the author
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BEDFORDSHIRE, U.K.—To begin this month’s roundup of tools and technology news, we have Mologic Ltd, which recently completed the development of a next-generation, ultra-sensitive, lateral flow-based technology platform. The novel diagnostics can be visually read and demonstrate up to a thousand-fold improvement in sensitivity over current technology.
 
With funding and support from the Bill & Melinda Gates Foundation, Mologic established the Center for Advanced Rapid Diagnostics (CARD) platform to deliver unprecedented improvements and innovation in lateral flow technology. The Mologic team has successfully reached an ambitious milestone in Phase 1 of attaining 1pg/ml of sensitivity in a visually read lateral flow device, taking point-of-care technology to levels of performance only previously attained with expensive laboratory equipment. The innovations at the core of the platform can be replicated for any protein or small molecule target with associated performance gains.
 
The program will now enter Phase 2 with a new grant of $4.9 million from the Gates Foundation to push the boundaries of sensitivity even further, broaden its applications to neglected diseases and accelerate product delivery. CARD will also help catalyze the formation of a responsive manufacturing and education facility in Senegal, diaTropix, in partnership with the Institut Pasteur de Dakar.
 

Automated endotoxin detection
 
WALKERSVILLE, Md. & BASEL, Switzerland—Lonza announced in April the global availability of the world’s first fully automated and integrated plate-based PyroTec PRO Robotic Solution for endotoxin testing. The system combines the speed and reproducibility of a robotic liquid handling platform with the power of version 6.0 of Lonza’s market-leading WinKQCL Software, and simplifies and accelerates endotoxin testing of parenteral pharmaceuticals regardless of sample complexity.
 
“As a fully automated system, the PyroTec PRO Solution captures preparation metadata, adding traceability into tracking, trending and audit controls,” noted Robert Porzio, product manager for endotoxin detection at Lonza.
 
The PyroTec PRO Solution is being tested for ease of use in a trial carried out at Lonza’s Chemical and Microbial Manufacturing site in Visp. The platform has been designed intrinsically to follow the FDA’s Process Analytical Technology and Data Integrity Initiatives and to comply with the U.S. Pharmacopeia Bacterial Endotoxin Test guidance.
 

LenS3 said to be a ‘new paradigm’ in light scattering technology
 
KING OF PRUSSIA, Pa.—Tosoh Bioscience LLC has introduced its LenS3 Multi-Angle Light Scattering (MALS) detector, offering a new approach for the measurement of molecular weight and radius of gyration of synthetic polymers, polysaccharides, proteins and biopolymers. A novel optical design, a unique cell-block assembly and a new calculation methodology make the LenS3 MALS detector the first groundbreaking innovation in the light scattering technology arena in decades.
 
The LenS3 MALS detector features a patent-pending cell geometry, a lower wavelength laser (at 514 nm), allows direct measurement of molecular weight and provides best-in-class sensitivity. With an improved normalization process and a new method for utilizing the angular dependence, the determination of radius of gyration of smaller macromolecules below 10 nm in gyration size is now possible.
 
The LenS3 MALS detector is driven by SECview software capable of GPC system/hardware control, multi-channel data acquisition, data processing and analysis. SECview is focused around enhancing the user-interface experience; it streamlines the complex calculations required by the advanced detectors and is currently the only GPC/SEC data processing module that performs analysis of sample of interest using multiple calibration methods simultaneously.
 

Customized microbiome models
 
RENSSELAER, N.Y.—Taconic Biosciences recently launched TruBIOME, a first-of-its-kind solution enabling the generation and maintenance of mice with custom microbiome profiles. TruBIOME was developed as a microbiome solution that affords increased predictability, reproducibility and systems biology insight within mouse model use. It’s the first platform that allows researchers to develop models with customized microbiota profiles and then expand to produce study cohorts with similar microbiomes via natural mating, all while monitored with extensive quality controls.
 
The TruBIOME solution also includes the Taconic Microbiota Repository, a collection of defined microbiome profiles. The collection currently includes the Wild Mouse gut microbiome licensed from the National Institute of Diabetes and Digestive and Kidney Diseases and Altered Schaedler Flora. TruBIOME also complements Taconic’s existing microbiome platform, which includes germ-free mice, germ-free derivations, and custom microbiota associations.
 
“Decades of experience leading the industry in commercial germ-free mouse production, germ-free derivation, and gnotobiotic husbandry services provide Taconic with a strong foundation to enable customers to access the solutions they need to address microbiome research challenges,” said Nancy Sandy, CEO of Taconic. “The launch of TruBIOME is exciting because it gives researchers the ability to learn how microbial variability impacts their animal model experiments.”
 

A new standard in deep immune profiling
 
SOUTH SAN FRANCISCO, Calif.—Fluidigm Corp. announced in March the introduction of the Maxpar Direct Immune Profiling System, which sets the new standard in immune profiling and empowers researchers to easily quantify 37 different immune cell populations from human peripheral blood mononuclear cells (PBMC) and whole blood, using a simple single-tube workflow with automated five-minute results reporting.
 
The highly multiplexed Maxpar Direct Immune Profiling System contains a 30-marker antibody panel that was developed with input from expert immunologists from academia and biopharma to identify and count 37 different immune cell subsets. Provided in a dry format in ready-to-use assay tubes, it enables researchers to easily stain samples and acquire results using the Fluidigm Helios mass cytometry system. The Maxpar Direct Immune Profiling Assay allows researchers to add up to seven new antibodies to the panel to support specific study goals.
 
Automated single-cell selection and results reporting is completed in five minutes using the Maxpar Pathsetter software, developed with Verity Software House. The optimized Maxpar Pathsetter report includes the quantitation and frequency of each immune cell population, visual cell maps and innovative in-sample QC metrics.
 
Code: E061928

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