QIAGEN | August 16, 2022
QIAGEN N.V. announced the launch of the QIAstat-Dx Viral Vesicular Panel RUO, the first syndromic test to differentiate between monkeypox and five other pathogens which cause similar symptoms.
The new panel – currently for research use only comes in cartridge form to run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It tests for the two known forms of monkeypox virus herpes simplex virus 1 HSV2, human herpesvirus 6 (HH6), varicella-zoster virus and enterovirus – pathogens that all produce similar-looking vesicular lesions.
With some 3,000 QIAstat-Dx PCR devices installed in specialized laboratories around the world, QIAGEN is leveraging the value of syndromic testing proven during the pandemic to help fight the spread of monkeypox, recently declared a public health emergency by the World Health Organization and the US government.
“Monkeypox cases are soaring across the globe with many demographic groups infected. Surveillance is an essential tool in the fight against infectious diseases. QIAstat-Dx Viral Vesicular Panel in combination with the QIAstat-Dx platform will allow medical researchers to detect monkeypox with gold-standard PCR testing-technology in about one hour. Currently the world’s only syndromic test for the pathogen, the panel will prove to be crucial for detecting and then combatting the spread of monkeypox around the globe.”
Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN
The panel’s RUO-status means it currently can only be used for the surveillance – not screening or diagnosing – of monkeypox cases. But QIAGEN is ready to make applications for clinical use should authorities in the United States and the European Union open new diagnostic pathways in light of this public-health emergency.
QIAGEN teams around the world are working with healthcare authorities to support testing for the monkeypox virus outbreak. The QIAstat syndromic testing solution adds to the broad portfolio that the company offers to address all testing needs. Alongside QIAGEN sample-technology kits, testing components and instruments that are used for instance by public health agencies for the development of their own tests, the NeuMoDx clinical PCR system allows laboratories to process self-developed tests (LDTs). A commercial single-plex assay running on this instrument is currently in development. The QIAcuity digital PCR also allows for monkeypox detection in wastewater – a surveillance method that proved its worth during the COVID-19 crisis.
The concept of syndromic testing has shown its value during the pandemic, when QIAGEN launched the QIAstat-Dx Respiratory SARS-CoV-2 panel to differentiate between up to 23 viral and bacterial targets for common pathogens causing respiratory tract infections. The company also introduced the high-throughput QIAstat-Dx Rise device that processes up 160 tests per day. QIAGEN has extended syndromic testing to other areas, including gastrointestinal conditions and meningitis.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics and Life Sciences . As of June 30, 2022, QIAGEN employed more than 6,100 people in over 35 locations worldwide.
Samsung Biologics | August 02, 2022
GreenLight Biosciences a biotechnology company dedicated to making ribonucleic acid products affordable and accessible for human health and agriculture, and Samsung Biologics a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies' mRNA production partnership.
Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung's commercial facility was completed in seven months, demonstrating platform adaptability and scalability.
GreenLight's process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight's mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.
The company's RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight's Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale.
"This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,"
John Rim, CEO and President at Samsung Biologics
Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients.
"One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production," said GreenLight CEO Andrey Zarur. "We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity."
To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight's process to Samsung Biologics' Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale.
About GreenLight Biosciences
GreenLight Biosciences aims to address some of the world's biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company's platform is protected by numerous patents. GreenLight's human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq.
SYNTHEGO | August 03, 2022
Synthego, the genome engineering company, announced the launch of Engineered Cell Libraries, a novel offering that further enables access to CRISPR by providing arrayed CRISPR-edited cells for direct use in functional screening assays. The innovative solution leverages Synthego’s Eclipse™ Platform. This high-throughput cell engineering platform delivers cell-based models for disease research by providing highly predictable CRISPR-engineered cells at scale through the integration of engineering, bioinformatics, and proprietary science. Synthego’s Engineered Cell Libraries provide unparalleled speed, scalability, and efficiency to accelerate the drug discovery process by enabling a faster path between experimental design and execution.
As the newest addition to Synthego's Engineered Cells product line, the offering is a custom arrayed library of multi-guide™ knockout cell pools (immortalized or iPSC) delivered ready-made to researchers, efficiently enabling them to bypass the need for equipment and reagent sourcing, transfection, generation of an extensive CRISPR library, and hiring and training of staff. This allows researchers to overcome common hurdles associated with CRISPR-based target discovery and focus specifically on the science.
“Arrayed screening approaches are more sensitive, compatible with a broader assortment of downstream assays, and can yield data that is more readily interpretable than the more commonly used pooled approach but are underutilized due to lack of infrastructure and limited bandwidth. With Engineered Cell Libraries, Synthego continues to provide transformative solutions for accelerated drug discovery which ultimately can bring a wider range of therapeutics to market faster.”
Travis Maures, Synthego’s Chief Technology Officer
With Engineered Cell Libraries, scientists specify the human or mouse cell type (Immortalized or iPSC available at launch) and gene targets they desire to knockout to generate a custom “Knockout Cell Library.” The cells are then edited on Synthego’s Eclipse Platform, which handles guide design, cell line optimization, editing through transfection, and assessment of editing efficiencies, so cells are ready to screen upon arrival.
Engineered Cell Libraries on the Eclipse Platform additionally benefit customers with
Scalability and flexibility - Engineered Cell Libraries allow researchers to maximize their screening power and identify more targets earlier in the screening process.
Predictability and transparency - Synthego’s multi-guide™ technology achieves reliably high knockout efficiencies so researchers can confidently proceed with their screens.
Cell engineering expertise and support - Synthego uses its expertise to bring automation innovation that provides greater consistency in outcomes and scalability.
Synthego’s Eclipse Platform and Engineered Cell Libraries enable a wide range of applications in research and development across various disease areas and research disciplines such as oncology and neurology. Engineered Cell Libraries were employed in a recent study that used genetic screening to identify host factors that either facilitate or inhibit infection by SARS-CoV-2 and that could potentially be targeted with existing drugs that have been approved for other indications.
“We were able to quickly combine our proteomic expertise with Synthego's genome engineering capabilities in a matter of weeks,” said Nevan J. Krogan, Director, Quantitative Biosciences Institute, University of California, San Francisco. “Normally, work such as this would take many years. We were able to quickly pinpoint which human genes are important for infection, and that allowed us to jump to which ones if we were able to drug them, could have a positive pharmacological effect on SARS-CoV-2 infection. That whole pipeline allowed us to identify several potential drug candidates, several of which we're still looking at.”
Ultimately, Synthego’s goal is to enable scientists to spend less time thinking about method development and more time running their functional assays. The addition of Engineered Cell Libraries is driving impact in biopharma research and development.
Synthego was founded to revolutionize genome engineering technology, helping translate genomics into the clinic and ultimately making engineered biological therapies accessible to all patients. The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance both basic research and therapeutic development programs. With its technologies cited in more than a thousand peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation enabling the next generation of medicines by delivering genome editing at an unprecedented scale.