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On the cutting edge
May 2020
by Mel J. Yeates  |  Email the author
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To start off this month’s roundup of tools and technology, we have news of a recent collaboration between Framingham, Mass.-based SCIEX and Newark, Calif.-based Intabio, which is meant to couple Intabio’s Blaze system with SCIEX’s high-resolution accurate mass (HRAM) systems. This partnership is geared towards accelerating and transforming biotherapeutic development and biomanufacturing.
 
“By coupling iCIEF separations directly to leading high-resolution MS systems, the Blaze system eliminates a serious laboratory bottleneck for drug developers,” said Dr. Lena Wu, Intabio CEO and co-founder. “Blaze integration with SCIEX flagship MS platforms will enable biopharma to accelerate critical decisions and ultimately reduce development timelines.”
 
The integration between Blaze and SCIEX HRAM systems reportedly provides imaged capillary isoelectric focusing with mass spectrometry (iCIEF-MS) in order to simultaneously characterize and identify intact protein charge variants. The successful integration of iCIEF-MS workflows will streamline current laborious and time-consuming approaches in the biopharma environment to identify, monitor and characterize critical quality attributes in intact protein samples for the development and manufacture of next-gen therapeutics.
 
The commercial release of the Blaze system is scheduled for the fourth quarter of 2020, and the integrated iCIEF-MS workflow will be available on SCIEX TripleTOF 6600+ systems.
 
A RT-qPCR kit for SARS-CoV-2 testing
GRAND RAPIDS, Mich.—Empirical Bioscience has reported that their QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR kits have been successfully tested in assays using EUA-authorized qPCR detection kits, using the established CDC testing protocol. The kits work by converting the CoV-2 RNA into DNA and amplifying to detect the presence of pathogenic material in patient samples.
 
The QuanTASE RT-qPCR Assay Kit operates on most existing laboratory testing equipment in the United States and includes all of the required RT-qPCR reaction reagents needed to run a COVID-19 test. The kit also meets the performance requirements for nCoV-2 testing established by the Centers for Disease Control (CDC), when used in accordance with CDC guidelines and in conjunction with an approved detection kit. The company expects the demand for the kits to continue accelerating, and it has adjusted production and delivery times accordingly.
 
“We are ramping up our production capacity from 50,000 kits a week to 100,000 a week,” said Des O’Farrell, president of Empirical Bioscience. “We are also offering 24-hour shipping.”
 
A new handheld raw material ID system
SANTA CLARA, Calif.—In late March, Agilent Technologies Inc. launched the newest instrument in its Raman technology portfolio. The Agilent Vaya Raman raw material identity verification system is a handheld instrument meant to accelerate quality control testing in the pharmaceutical and biopharmaceutical industries.
 
Vaya verifies raw material identity through both transparent and non-transparent unopened packaging. It reportedly tests more containers for the same cost by reducing the need for sampling. Incoming goods can be quickly tested in the warehouse on receipt, reducing operator time and sample-handling booth usage. Testing through sealed containers also avoids handler exposure to high-potency APIs, maintains the shelf life of sterile contents and helps to prevent unnecessary waste.
 
“Improving the speed and efficiency of raw material testing has a major impact on pharma and biopharma manufacturing. Testing requirements are trending toward higher volumes, even 100 percent of containers in many cases, and conventional techniques can be extremely resource-intensive,” noted Paul Loeffen, Agilent vice president and general manager of the company’s Molecular Spectroscopy Division. “Vaya’s through-container capability bypasses the bottlenecks, offering our customers a significant cost- and resource-saving solution.”
 
Vaya incorporates Agilent’s spatially offset Raman spectroscopy with conventional Raman spectroscopy for maximum compatibility, with a wide range of packaging—from clear glass vials and plastic bags, to opaque plastics and paper sacks.
 
Presenting pre-packed process development columns
KING OF PRUSSIA, Pa.—Tosoh Bioscience LLC has introduced its SkillPak 1 mL and 5 mL pre-packed columns to the market. These process development columns are designed for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins and viruses.
 
SkillPak 1 mL and 5 mL columns are pre-packed with TOYOPEARL, TSKgel or Ca⁺⁺Pure-HA process chromatography media. The columns deliver high performance and offer scalability and convenience, giving customers greater flexibility for use of process media from Tosoh. They are ready to use upon receipt, and show excellent physical strength and ideal flow characteristics for industrial downstream processing.
 
SkillPak 1 mL and 5 mL pre-packed columns are available with short delivery times in affinity, anion and cation exchange, hydrophobic interaction and size exclusion chromatographic modes. Optimal performance is guaranteed with the columns, and they can be operated directly with commonly used low- or medium-pressure liquid chromatography systems.
 
GenoFAB Inc. teams up with Decisions LLC
FORT COLLINS, Colo.—GenoFAB Inc. recently announced a partnership with Decisions LLC to help accelerate biomedical research projects. With the recent worldwide health concerns, increased research productivity through automation is more important than ever—especially in the development and manufacturing of vaccines and antiviral drugs. Decisions notes that the company has a long track record of helping companies increase their productivity across many industries, including healthcare, life sciences, finance, logistics and operations.
 
“We are all facing unprecedented challenges. GenoFAB is committed to helping research organizations transform their operations at a time when they need it most,” stated Dr. Jean Peccoud, GenoFAB's CEO. “Cost reductions, productivity gains and increased reproducibility are proven benefits of automation that can accelerate the development of life-saving drugs.”
 
COVID-19 has starkly illustrated the need to accelerate the development of critical medicines and vaccines. But over the last decade, productivity within the pharmaceutical sector has drastically decreased, according to industry analysts. Reversing this trend will require changing the way biomedical research is performed. The biotechnology industry increasingly involves global networks of scientific partners which contribute to the same overarching goal to develop and produce effective biological solutions for pressing problems. Strong and evolving partnerships between research organizations, service providers and automation companies will be key to the success of this enterprise.
 
A number of companies provide laboratory information management systems and electronic laboratory notebooks software solutions to record data. These systems require lab personnel to report data and laboratory operations as each project progresses. Rather than focusing on data capture, GenoFAB’s Automation Platform drives the execution of laboratory processes, automating the generation and recording of data while extracting the actionable information that different stakeholders need to contribute to the overall success of each project. The platform also includes computational steps executed in software and experiment performed by collaborators and contractors.
 
Code: E052029

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