Danish company Samplix has launched its comprehensive service program to grant any laboratory access to the advantages of Xdrop™ technology. By partnering with the Samplix Service Team, researchers can leverage the unique Xdrop™ approach to address complex genomic questions, including gap closing, sequencing of repeat elements, detecting viral insertion sites, revealing unintended CRISPR edits, and more.
Xdrop™ is Samplix’s proprietary technology to enrich genomic regions longer than 100 kb from as little as 1 ng human genomic DNA and with single-molecule resolution. Unlike other target enrichment methods, Xdrop™ requires knowledge of only a short sequence within or flanking the target region for efficient target selection. Following targeted selection, multiple displacement amplification is applied to single DNA molecules compartmentalized in droplets. This ensures unbiased amplification of large DNA fragments that are representative of the target variation in the original sample. The output is ready for any short-read or long-read sequencing platform.
Commenting on the service, Henrik Pfundheller, VP Commercial Operations, said: “Our services program is designed to expertly manage workflow points that impact project success. We have regular customer consultations to establish clear research objectives and thus, secure the right experimental setup and sample quality strategy.”
The complete workflow is managed by an expert team of scientists and lab technicians with more than 10 years of experience in international genomics services, handling of precious sample types, project logistics, and dedicated customer care. Upon request, Samplix Services also performs and analyses long-read or short-read sequencing. Every step, including data processing and analysis, if requested, is carefully documented and discussed in a closing consultation.
“Whatever the reason behind a service request," added Pfundheller, “our team overcomes any challenge our customers experience, whether it relates to exploring a new application, getting help in tackling a difficult sequence, or just gaining access to the right equipment."
For more information, visit: www.samplix.com/services Read more
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Horizon Discovery Group, a leader in the application of gene editing and gene modulation for cell line engineering, says its cGMP-compliant CHOSOURCE™ platform has played a key role in generating a stable cell line for the development of an immunotherapy for autoimmune diseases. Horizon’s pharmaceutical-grade, stable Chinese Hamster Ovary (CHO) cells delivered high yields of monoclonal antibody for LAG-3 immunotherapy, enabling Immutep and Batavia Biosciences to reach an important milestone in the preclinical development of the compound.
Horizon’s gene-edited Glutamine Synthetase (GS) knockout CHO K1 cell line expression system, offered by Batavia Biosciences as part of its STEP®-mAb service, was used to generate a high yielding cell line for Immutep’s IMP761 product candidate, an agonist antibody targeting the immune checkpoint lymphocyte activation gene (LAG)-3. LAG-3 controls the signalling between specific immune cells, T cells and antigen presenting cells, which are responsible for the adaptive immune response, making it a promising focus for novel cancer therapies or for the treatment of autoimmune conditions, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
Horizon’s GS expression system facilitates the development of stable cell lines for the expression of antibodies and other recombinant proteins and is recognized in the industry and by regulators as suitable for high yield biomanufacturing. Its CHOSOURCE biomanufacturing platform helps companies to move from the DNA sequence of their potential biotherapeutic to clinical manufacturing as simply and rapidly as possible. The platform is versatile and suitable for a broad range of monoclonal antibody therapeutics, delivering higher-than-anticipated yields of less commonly used IgG4-based antibodies, such as IMP761.
Terry Pizzie, CEO, Horizon Discovery said: “We are dedicated to ensuring availability of key technologies that can improve affordability of medicines worldwide. Our CHOSOURCE biomanufacturing platform is empowering organizations from early stage start-ups to large pharmaceutical companies to drive efficiencies throughout development and production and has already been utilized in multiple successful innovative new drug filings.”
The complete CHOSOURCE system includes the GS knockout CHO K1 cell line, a comprehensive package of supporting documentation, and an expression vector supplied under license from DNATwoPointO, Inc.
• For more information, visit: https://horizondiscovery.com/navigation/cho-cells Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Horizon_chosource_TerryPizzie_CEO.jpg163224493wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:16:522021-01-08 11:20:34Horizon Discovery CHOSOURCE platform supports development of immunotherapy for autoimmune diseases
Horizon Discovery Group, a global leader in the application of gene editing and gene modulation for cell line engineering, has added two new sample formats to its cell-based OncoSpan reference standards for use in the development and validation of workflows for cancer diagnostic assays.
Horizon’s OncoSpan range now includes formalin-fixed, paraffin-embedded (FFPE) and cell-free DNA (cfDNA) formats for mimicking solid tumors and liquid biopsy samples, respectively, in addition to its well-established genomic DNA (gDNA) format. Its cfDNA format offers one of the largest number of variants and genes, over 380 and 152 respectively, of any characterized reference standard to help standardize liquid biopsy testing.
These cell-line derived reference standards closely mimic patient samples and offer an unlimited and reproducible resource to help ensure consistency during the establishment and validation of diagnostic assays. All three formats are delivered with batch-specific, next-generation sequencing (NGS) data, orthogonally validated by ddPCR, to allow researchers to further validate their analysis pipeline.
For further information, visit: horizondiscovery.com/en/products/diagnostic-reference-standards/PIFs/OncoSpan-cfDNA Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/horizon_discovery-scaled.jpg256025603wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:16:522021-01-08 11:20:34Horizon Discovery extends coverage of OncoSpan reference standards to FFPE and Liquid Biopsy
Bio-Rad Laboratories, a specialist in life science research and clinical diagnostic products, has extended its range of recombinant monoclonal anti-idiotypic antibodies with the introduction of antibodies that are specific for ipilimumab (Yervoy) and the ipilimumab/CTLA-4 drug-target complex. These highly specific and high-affinity antibodies are suitable for bioanalytical and patient drug level monitoring assays for the immune checkpoint inhibitor: ipilimumab.
Bio-Rad also announced the launch of a range of anti-certolizumab pegol inhibitory antibodies to support the development of assays for therapeutic drug monitoring of tumor necrosis factor (TNF) alpha inhibitors.
Ipilimumab activates the immune system by inhibiting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that hinders the destruction of cancerous cells, to treat cancers such as melanoma. The four anti-ipilimumab antibodies inhibit the binding of the drug to its target, CTLA-4, and therefore detect free drug. These antibodies are suitable for developing pharmacokinetic (PK) bridging ELISAs and being used as a surrogate positive control (or reference standard) for anti-drug antibody assays. The drug-target complex binder specifically recognizes the ipilimumab/CTLA-4 complex and can be used as the detection antibody in a PK antigen capture assay as an alternative format to the bridging ELISA.
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
The anti-ipilimumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring. Anti-certolizumab pegol inhibitory antibodies
The range of recombinant monoclonal anti-idiotypic antibodies comprises three antibodies that are highly specific for the monoclonal antibody Fab fragment certolizumab pegol (Cimzia) and inhibit the binding of this drug to its target: TNF alpha. The antibodies are fully human in full length IgG format and can be used as a surrogate positive control or calibration standard for an ADA assay to measure levels of patient anti-drug antibodies.
TNF alpha inhibitors are used to treat a wide range of inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. The levels of serum drug and ADA concentrations are monitored in patients receiving TNF alpha antagonists to help guide clinical decision making, optimize treatment, improve outcomes, and reduce healthcare costs.
The anti-certolizumab pegol antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring. Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/biorad_May_29.png3784163wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:16:522021-01-08 11:20:34Bio-Rad introduces new antibodies for in vitro research, commercial applications
Provides high efficiency, saves space and enables multi-sample processing / Customer- and application-specific solution / Time-saving by simplified, fast operation
Shimadzu, one of the world leaders in analytical instrumentation, has announced the release of its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). “Preparative HPLC” is a process in which specific substances are separated and purified from samples. The new Nexera Prep Series provides better prep processes for extraction of functional and impurity components, as well as purification of target compounds in the pharmaceutical, chemical and food industries. This product dramatically improves productivity via flexible scalability and an efficient, user friendly preparative workflow. Customer- and application-specific solution The Nexera Prep Series consists of multiple related products with the LC units as the core. Users select a pump, autosampler and detector to build a system according to the purpose of the preparative work. Systems can be configured using related products such as the LH-40 Liquid Handler, FRC-40 Fraction Collector, Shim-pack Scepter LC Column for Analysis and Preparative Work, and Column Hub.
Preparative purification is generally performed following a multi-step workflow, which requires experience and time:
Selection of system configuration and preparative column size based on the amount
of purified sample or injection volume required
Selection of fraction collector and container size according to the intended purpose
Investigation of separation conditions in analytical scale
Optimization of preparative LC conditions
Confirmation of the purity of collected fractions
In addition to these steps, in some cases salts need to be removed or solvent needs to be evaporated after purification, requiring additional time and effort. Time-saving by simplified, fast operation The Nexera Prep Series reduces the time spent on examining conditions using the software’s fractionation simulation function. It also enables simplified, fast operation in transition from analytical to preparative scale, with a column portfolio that covers a wide range of sizes. Furthermore, Shimadzu’s unique UFPLC (Ultra Fast Preparative and Purification LC) high-purity purification system reduces the time required for powderization via the elution of desalted target components with an organic solvent. This product satisfies a number of user demands, such as efficient desalting and powderization, multi-sample and multi-fraction analysis, effective separation at low cost and the ability to check the purity.
Specifically, the product can be used for the following purposes:
Concentration and purification of immunosuppressive agents
Preparative work for impurities in degradants of medicinal agents
Separation and purification of functional components from natural materials
Consecutive analysis to separate and purify polymers and their additives and confirm the purity
The Nexera Prep Purification LC System provides new features to simplify the preparative workflow:
Reduces the time required for investigating conditions With the fractionation simulation function of the LabSolutions analysis software and the Shim-pack Scepter LC column for analytical and preparative HPLC, which offers excellent scalability, the product reduces the time required for investigating preparative work conditions. The LH-40 Liquid Handler can be used both, as a fraction collector and as an autosampler for large-volume injection with liquid surface detection function (option). It also enables seamless purity checks through re-injection (option) of collected sample after fractionation. Additional features including a sample rescue protocol to collect the sample from the system if an error occurs after an injection, a function to automatically extract the target peaks only, and high-purity preparative purification using detector signals from up to four channels, enable more efficient operation.
UFPLC high-purity purification system Samples must be in a state of concentrated solution or dry powder to analyze their structure or to store them. When a solution contains water, it takes time to dry and concentrate it. When a salt such as trifluoroacetate has been added, it remains in the crystal of the compound, lowering the purity and negatively influencing pharmacokinetic studies and other tests. Shimadzu’s unique, automated UFPLC purification system introduces fractions containing the target compound, separated in a preparative column, into a trap column. Salt and water are then washed off and elution is induced with an organic solvent. This reduces the time required for drying, providing compounds with a high level of purity.
Flexible system scalability Both the LH-40 Liquid Handler and FRC-40 Fraction Collector are designed to save installation space, requiring only half the space of other vendors’ products. They support containers of a form and size suitable for the recovered quantity. Up to six units can be connected, so up to 3240 10 mm diameter test tubes can be placed. Using the new Column Hub, up to six columns and four flow-line switching valves can be installed, enabling the compact configuration of various systems.
Web summary Shimadzu has announced the release of its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). It provides better prep processes for extraction of target compounds and impurities during drug discovery in the pharmaceutical industry and purification of functional components in the chemical and food industries. This product improves productivity dramatically via efficient preparative workflows using LC or LC-MS methodology.
Web link: www.shimadzu.eu/nexera-prep Read more
Siemens Healthineers’s INNOVANCE assays help improve efficiencies, workflow and resource management following a COVID-19 diagnosis.
In hospitalised COVID-19 patients, elevated D-dimer levels have been found to be strongly associated with disease severity and even mortality reflecting the procoagulant status and high thrombotic risk observed in many COVID-19 patients. Therefore, the monitoring of D-dimer levels is recommended for hospitalised COVID-19 patients to stratify their thrombotic risk including testing for deep vein thrombosis and pulmonary embolism and guiding treatment over the course of the disease.
Treating COVID-19 patients with anticoagulants has been associated with improved outcomes, both in and out of the intensive care unit setting.
Accurate antithrombin measurement in COVID-19 patients undergoing anticoagulant treatment may be useful to determine the efficacy of anticoagulant therapy as antithrombin levels might be reduced.
Siemens Healthineers has a comprehensive portfolio of assays for detection and monitoring of coagulation disorders.
For more information, visit: https://www.siemenshealthineers.com/hemostasis/ innovance-reagents-for-coagulation-disorders Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_SIEMENS_1.jpg2136953wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:16:522021-01-08 11:20:33INNOVANCE reagents support management of COVID-19 patients
Germany-based Tosoh Bioscience has introduced SkillPak 1 mL and 5 mL pre-packed process development columns designed for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
Tosoh Bioscience, a subsidiary of Tosoh Corporation in Japan, specialises in providing chromatographic solutions for the separation and purification of biomolecules.
Pre-packed with TOYOPEARL®, TSKgel® or Ca++Pure-HA® process chromatography media, SkillPak 1 mL and 5 mL columns deliver high performance and offer scalability and convenience. These columns are ready to use upon receipt and show excellent physical strength and ideal flow characteristics for industrial downstream processing. The 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.
SkillPak 1 mL and 5 mL pre-packed columns are available for sale in Europe, Africa and the Middle East.
For more information, visit: https://www.separations. eu.tosohbioscience.com/solutions/process-mediaproducts/ process-development/skillpak Read more
Awareness Technology’s new ChemWell 2 analyzer for ELISA and chemiluminescent (CLIA) is now available.
The ChemWell 2 is a two-probe, two-plate automatic combo analyzer. For 20 years the company has produced single-plate ChemWell automatic ELISA and CLIA systems with the flexibility to run both modes simultaneously even within the same plate. With laboratories expanding serology requirements, the two-plate system is expected to be a more suitable primary instrument for lower throughput labs, and ideal for off-line assays in higher throughput settings.
ChemWell’s flexibility in both hardware and software is key to automating a wide variety of unrelated test methods. Separate probes are used for samples and reagents with an option for disposable tips. Filters range from 405 nm – 630 nm; dispense volume from 2μL to 1.95 ml; plate washing routines, temperature control, and mixing are programmable. Intuitive software offers on-board predilutions, multiple calibration options, replicates, statistics, QC tracking, barcoded sample ID and data management. Additionally, it schedules assays to prevent timing conflicts while providing optimal throughput. An optional laptop stand conserves bench space.
For more information, visit: www.awaretech.com Read more
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Siemens Healthineers has a released an informative eBook titled “Coagulation abnormalities in COVID-19 patients – current testing and treatment protocols” to provide quick access to coagulation testing and treatment recommendations.
The eBook can be downloaded for free from their website: https://bit.ly/2CcpB5I
Because coagulation tests are important in the management of COVID-19 patients, the company has compiled an eBook for quick access to:
Thrombosis risk factors
An ISTH-recommended coagulation testing algorithm
Leading recommendations for anticoagulation treatment
Relevant parameters for patient monitoring
The eBook provides an overview of COVID-19 and thrombosis; it looks at laboratory testing in the identification of coagulation abnormalities in COVID-19 patients; and provides information on the treatment of coagulation abnormalities in COVID-19 patients.
Authors of the eBook write that while it’s not unusual for infections to raise the risk of clotting, the COVID-19 virus is associated with an unprecedented range of clotting-related disorders in affected patients. “From benign skin lesions on the feet to life-threatening thrombotic events, the COVID-19 virus has demonstrated a strikingly high prevalence of deadly blood clots. Studies show that about 25% and even up to 70% of critically ill patients have confirmed venous thromboembolism or pulmonary embolism. Another study found that approximately 70% of COVID-19 patients who died had disseminated intravascular coagulation.”
They add that Siemens Healthineers’s coagulation tests play an important role in the diagnosis, treatment, and management of coagulation abnormalities in COVID-19 patients and point out that the company has changed their production model to produce these assays at a higher volume than ever before.
“We are proud to support you in the fight against COVID-19. Behind every healthcare professional there are 53,000 Healthineers,” Siemens Healthineers says. Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_SIEMENS_2.jpg4176923wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:16:522021-01-08 11:20:32Siemens Healthineers releases free eBook on coagulation testing protocols for COVID-19 patients
Thermo Fisher Scientific has introduced several new products that build on its leading Orbitrap platform and expand research applications. The new Thermo Scientific Orbitrap Exploris 240 mass spectrometer is designed to give scientists working in proteomics, metabolomics, biopharmaceutical characterisation and small-molecules, the analytical performance required for research and high-throughput analyses. The company says the new system will advance discovery and identification with increased accuracy for confident scale-up, while providing operational simplicity and streamlining time-to-result.
Thermo Fisher Scientific pointed out that the new mass spectrometer delivers qualitative and quantitative capabilities synonymous with Orbitrap high-resolution accurate-mass (HRAM) spectrometry, with internal calibration that assures consistent data quality and decision making. These newest systems extend the Thermo Scientific Orbitrap Exploris portfolio of HRAM systems, which were introduced in 2019 with the release of the new-generation Thermo Scientific Orbitrap Exploris 480 mass spectrometer. Software Thermo Scientific Proteome Discoverer 2.5 software provides high confidence during peptide identification, accurate quantification and high throughput data analysis for proteomics researchers. Deep learning-based prediction of tandem mass spectra, facilitated through a new collaboration with MSAID, a software company transforming proteomics through deep learning, enables more scientists to benefit from major improvements in identification confidence and reproducibility.
To further enhance characterisation of protein biotherapeutics and oligonucleotide therapeutics, biopharmaceutical laboratories use the Thermo Scientific BioPharma Finder 4.0 software, which provides greater flexibility and customisation for this growing industry.
For small molecule researchers, Thermo Scientific Compound Discoverer 3.2 software further automates unknown compound identification performed on Thermo Scientific Orbitrap Gas Chromatography- Mass Spectrometry (GC-MS) systems to improve productivity.
In addition, the new Thermo Scientific Xcalibur 4.4 software brings the AcquireX intelligent data acquisition workflow to Thermo Scientific Orbitrap Exploris mass spectrometry platform users, enabling the fully automated acquisition of high quality MS/MS data and reducing manual input and repeat runs. Collaboration Thermo Fisher Scientific’s collaboration with Evosep, a leading provider of sample preparation technologies for protein-based clinical research, supports the development of high-throughput clinical research workflows for profiling large plasma sample cohorts for proteomics, translational research and pharmaceutical applications. This partnership recently led to the launch of an automated ultra-high throughput plasma protein profiling platform, combing the power of the new Thermo Scientific Orbitrap Exploris 240 mass spectrometer with the Evosep One liquid chromatography solution.
The company’s collaboration with Biognosys, a leading developer of next-generation proteomics solutions, resulted in the development of data-independent acquisition mass spectrometrybased workflows, which enhances sensitivity and coverage for proteomic research in translational and clinical labs. The collaboration includes a novel FAIMS-DIA method that features the Thermo Scientific FAIMS Pro interface, which improves selectivity, reproducibility and proteome coverage, as well as new methods that streamline discovery by combining Thermo Scientific SureQuant Targeted Assay Kits and the Biognosys PQ500 kit in a single workflow.
For more information, visit: www.thermofisher.com Read more
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Samplix offers its proprietary Xdrop technology to other labs
, /in Product News /by 3wmediaDanish company Samplix has launched its comprehensive service program to grant any laboratory access to the advantages of Xdrop™ technology. By partnering with the Samplix Service Team, researchers can leverage the unique Xdrop™ approach to address complex genomic questions, including gap closing, sequencing of repeat elements, detecting viral insertion sites, revealing unintended CRISPR edits, and more.
Xdrop™ is Samplix’s proprietary technology to enrich genomic regions longer than 100 kb from as little as 1 ng human genomic DNA and with single-molecule resolution. Unlike other target enrichment methods, Xdrop™ requires knowledge of only a short sequence within or flanking the target region for efficient target selection. Following targeted selection, multiple displacement amplification is applied to single DNA molecules compartmentalized in droplets. This ensures unbiased amplification of large DNA fragments that are representative of the target variation in the original sample. The output is ready for any short-read or long-read sequencing platform.
Commenting on the service, Henrik Pfundheller, VP Commercial Operations, said: “Our services program is designed to expertly manage workflow points that impact project success. We have regular customer consultations to establish clear research objectives and thus, secure the right experimental setup and sample quality strategy.”
The complete workflow is managed by an expert team of scientists and lab technicians with more than 10 years of experience in international genomics services, handling of precious sample types, project logistics, and dedicated customer care. Upon request, Samplix Services also performs and analyses long-read or short-read sequencing. Every step, including data processing and analysis, if requested, is carefully documented and discussed in a closing consultation.
“Whatever the reason behind a service request," added Pfundheller, “our team overcomes any challenge our customers experience, whether it relates to exploring a new application, getting help in tackling a difficult sequence, or just gaining access to the right equipment."
For more information, visit: www.samplix.com/services
Read more
Horizon Discovery CHOSOURCE platform supports development of immunotherapy for autoimmune diseases
, /in Product News /by 3wmediaHorizon Discovery Group, a leader in the application of gene editing and gene modulation for cell line engineering, says its cGMP-compliant CHOSOURCE™ platform has played a key role in generating a stable cell line for the development of an immunotherapy for autoimmune diseases. Horizon’s pharmaceutical-grade, stable Chinese Hamster Ovary (CHO) cells delivered high yields of monoclonal antibody for LAG-3 immunotherapy, enabling Immutep and Batavia Biosciences to reach an important milestone in the preclinical development of the compound.
Horizon’s gene-edited Glutamine Synthetase (GS) knockout CHO K1 cell line expression system, offered by Batavia Biosciences as part of its STEP®-mAb service, was used to generate a high yielding cell line for Immutep’s IMP761 product candidate, an agonist antibody targeting the immune checkpoint lymphocyte activation gene (LAG)-3. LAG-3 controls the signalling between specific immune cells, T cells and antigen presenting cells, which are responsible for the adaptive immune response, making it a promising focus for novel cancer therapies or for the treatment of autoimmune conditions, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
Horizon’s GS expression system facilitates the development of stable cell lines for the expression of antibodies and other recombinant proteins and is recognized in the industry and by regulators as suitable for high yield biomanufacturing. Its CHOSOURCE biomanufacturing platform helps companies to move from the DNA sequence of their potential biotherapeutic to clinical manufacturing as simply and rapidly as possible. The platform is versatile and suitable for a broad range of monoclonal antibody therapeutics, delivering higher-than-anticipated yields of less commonly used IgG4-based antibodies, such as IMP761.
Terry Pizzie, CEO, Horizon Discovery said: “We are dedicated to ensuring availability of key technologies that can improve affordability of medicines worldwide. Our CHOSOURCE biomanufacturing platform is empowering organizations from early stage start-ups to large pharmaceutical companies to drive efficiencies throughout development and production and has already been utilized in multiple successful innovative new drug filings.”
The complete CHOSOURCE system includes the GS knockout CHO K1 cell line, a comprehensive package of supporting documentation, and an expression vector supplied under license from DNATwoPointO, Inc.
• For more information, visit: https://horizondiscovery.com/navigation/cho-cells
Read more
Horizon Discovery extends coverage of OncoSpan reference standards to FFPE and Liquid Biopsy
, /in Product News /by 3wmediaHorizon Discovery Group, a global leader in the application of gene editing and gene modulation for cell line engineering, has added two new sample formats to its cell-based OncoSpan reference standards for use in the development and validation of workflows for cancer diagnostic assays.
Horizon’s OncoSpan range now includes formalin-fixed, paraffin-embedded (FFPE) and cell-free DNA (cfDNA) formats for mimicking solid tumors and liquid biopsy samples, respectively, in addition to its well-established genomic DNA (gDNA) format. Its cfDNA format offers one of the largest number of variants and genes, over 380 and 152 respectively, of any characterized reference standard to help standardize liquid biopsy testing.
These cell-line derived reference standards closely mimic patient samples and offer an unlimited and reproducible resource to help ensure consistency during the establishment and validation of diagnostic assays. All three formats are delivered with batch-specific, next-generation sequencing (NGS) data, orthogonally validated by ddPCR, to allow researchers to further validate their analysis pipeline.
For further information, visit: horizondiscovery.com/en/products/diagnostic-reference-standards/PIFs/OncoSpan-cfDNA
Read more
Bio-Rad introduces new antibodies for in vitro research, commercial applications
, /in Product News /by 3wmediaBio-Rad Laboratories, a specialist in life science research and clinical diagnostic products, has extended its range of recombinant monoclonal anti-idiotypic antibodies with the introduction of antibodies that are specific for ipilimumab (Yervoy) and the ipilimumab/CTLA-4 drug-target complex. These highly specific and high-affinity antibodies are suitable for bioanalytical and patient drug level monitoring assays for the immune checkpoint inhibitor: ipilimumab.
Bio-Rad also announced the launch of a range of anti-certolizumab pegol inhibitory antibodies to support the development of assays for therapeutic drug monitoring of tumor necrosis factor (TNF) alpha inhibitors.
Ipilimumab activates the immune system by inhibiting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that hinders the destruction of cancerous cells, to treat cancers such as melanoma. The four anti-ipilimumab antibodies inhibit the binding of the drug to its target, CTLA-4, and therefore detect free drug. These antibodies are suitable for developing pharmacokinetic (PK) bridging ELISAs and being used as a surrogate positive control (or reference standard) for anti-drug antibody assays. The drug-target complex binder specifically recognizes the ipilimumab/CTLA-4 complex and can be used as the detection antibody in a PK antigen capture assay as an alternative format to the bridging ELISA.
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
The anti-ipilimumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
Anti-certolizumab pegol inhibitory antibodies
The range of recombinant monoclonal anti-idiotypic antibodies comprises three antibodies that are highly specific for the monoclonal antibody Fab fragment certolizumab pegol (Cimzia) and inhibit the binding of this drug to its target: TNF alpha. The antibodies are fully human in full length IgG format and can be used as a surrogate positive control or calibration standard for an ADA assay to measure levels of patient anti-drug antibodies.
TNF alpha inhibitors are used to treat a wide range of inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. The levels of serum drug and ADA concentrations are monitored in patients receiving TNF alpha antagonists to help guide clinical decision making, optimize treatment, improve outcomes, and reduce healthcare costs.
The anti-certolizumab pegol antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
Read more
Better Prep!
, /in Product News /by 3wmediaProvides high efficiency, saves space and enables multi-sample processing /
Customer- and application-specific solution /
Time-saving by simplified, fast operation
Shimadzu, one of the world leaders in analytical instrumentation, has announced the release of its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). “Preparative HPLC” is a process in which specific substances are separated and purified from samples. The new Nexera Prep Series provides better prep processes for extraction of functional and impurity components, as well as purification of target compounds in the pharmaceutical, chemical and food industries. This product dramatically improves productivity via flexible scalability and an efficient, user friendly preparative workflow.
Customer- and application-specific solution
The Nexera Prep Series consists of multiple related products with the LC units as the core. Users select a pump, autosampler and detector to build a system according to the purpose of the preparative work. Systems can be configured using related products such as the LH-40 Liquid Handler, FRC-40 Fraction Collector, Shim-pack Scepter LC Column for Analysis and Preparative Work, and Column Hub.
Preparative purification is generally performed following a multi-step workflow, which requires experience and time:
of purified sample or injection volume required
In addition to these steps, in some cases salts need to be removed or solvent needs to be evaporated after purification, requiring additional time and effort.
Time-saving by simplified, fast operation
The Nexera Prep Series reduces the time spent on examining conditions using the software’s fractionation simulation function. It also enables simplified, fast operation in transition from analytical to preparative scale, with a column portfolio that covers a wide range of sizes. Furthermore, Shimadzu’s unique UFPLC (Ultra Fast Preparative and Purification LC) high-purity purification system reduces the time required for powderization via the elution of desalted target components with an organic solvent. This product satisfies a number of user demands, such as efficient desalting and powderization, multi-sample and multi-fraction analysis, effective separation at low cost and the ability to check the purity.
Specifically, the product can be used for the following purposes:
The Nexera Prep Purification LC System provides new features to simplify the preparative workflow:
With the fractionation simulation function of the LabSolutions analysis software and the Shim-pack Scepter LC column for analytical and preparative HPLC, which offers excellent scalability, the product reduces the time required for investigating preparative work conditions. The LH-40 Liquid Handler can be used both, as a fraction collector and as an autosampler for large-volume injection with liquid surface detection function (option). It also enables seamless purity checks through re-injection (option) of collected sample after fractionation. Additional features including a sample rescue protocol to collect the sample from the system if an error occurs after an injection, a function to automatically extract the target peaks only, and high-purity preparative purification using detector signals from up to four channels, enable more efficient operation.
Samples must be in a state of concentrated solution or dry powder to analyze their structure or to store them. When a solution contains water, it takes time to dry and concentrate it. When a salt such as trifluoroacetate has been added, it remains in the crystal of the compound, lowering the purity and negatively influencing pharmacokinetic studies and other tests. Shimadzu’s unique, automated UFPLC purification system introduces fractions containing the target compound, separated in a preparative column, into a trap column. Salt and water are then washed off and elution is induced with an organic solvent. This reduces the time required for drying, providing compounds with a high level of purity.
Both the LH-40 Liquid Handler and FRC-40 Fraction Collector are designed to save installation space, requiring only half the space of other vendors’ products. They support containers of a form and size suitable for the recovered quantity. Up to six units can be connected, so up to 3240 10 mm diameter test tubes can be placed. Using the new Column Hub, up to six columns and four flow-line switching valves can be installed, enabling the compact configuration of various systems.
Web summary
Shimadzu has announced the release of its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). It provides better prep processes for extraction of target compounds and impurities during drug discovery in the pharmaceutical industry and purification of functional components in the chemical and food industries. This product improves productivity dramatically via efficient preparative workflows using LC or LC-MS methodology.
Web link: www.shimadzu.eu/nexera-prep
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INNOVANCE reagents support management of COVID-19 patients
, /in Corona News, Product News /by 3wmediaSiemens Healthineers’s INNOVANCE assays help improve efficiencies, workflow and resource management following a COVID-19 diagnosis.
In hospitalised COVID-19 patients, elevated D-dimer levels have been found to be strongly associated with disease severity and even mortality reflecting the procoagulant status and high thrombotic risk observed in many COVID-19 patients. Therefore, the monitoring of D-dimer levels is recommended for hospitalised COVID-19 patients to stratify their thrombotic risk including testing for deep vein thrombosis and pulmonary embolism and guiding treatment over the course of the disease.
Treating COVID-19 patients with anticoagulants has been associated with improved outcomes, both in and out of the intensive care unit setting.
Accurate antithrombin measurement in COVID-19 patients undergoing anticoagulant treatment may be useful to determine the efficacy of anticoagulant therapy as antithrombin levels might be reduced.
Siemens Healthineers has a comprehensive portfolio of assays for detection and monitoring of coagulation disorders.
For more information, visit: https://www.siemenshealthineers.com/hemostasis/ innovance-reagents-for-coagulation-disorders
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Tosoh Bioscience introduces SkillPak pre-packed columns
, /in Product News /by 3wmediaGermany-based Tosoh Bioscience has introduced SkillPak 1 mL and 5 mL pre-packed process development columns designed for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
Tosoh Bioscience, a subsidiary of Tosoh Corporation in Japan, specialises in providing chromatographic solutions for the separation and purification of biomolecules.
Pre-packed with TOYOPEARL®, TSKgel® or Ca++Pure-HA® process chromatography media, SkillPak 1 mL and 5 mL columns deliver high performance and offer scalability and convenience. These columns are ready to use upon receipt and show excellent physical strength and ideal flow characteristics for industrial downstream processing. The 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.
SkillPak 1 mL and 5 mL pre-packed columns are available for sale in Europe, Africa and the Middle East.
For more information, visit: https://www.separations. eu.tosohbioscience.com/solutions/process-mediaproducts/ process-development/skillpak
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Awareness Technology releases ChemWell 2, a two-plate ELISA and chemiluminescent analyzer
, /in Product News /by 3wmediaAwareness Technology’s new ChemWell 2 analyzer for ELISA and chemiluminescent (CLIA) is now available.
The ChemWell 2 is a two-probe, two-plate automatic combo analyzer. For 20 years the company has produced single-plate ChemWell automatic ELISA and CLIA systems with the flexibility to run both modes simultaneously even within the same plate. With laboratories expanding serology requirements, the two-plate system is expected to be a more suitable primary instrument for lower throughput labs, and ideal for off-line assays in higher throughput settings.
ChemWell’s flexibility in both hardware and software is key to automating a wide variety of unrelated test methods. Separate probes are used for samples and reagents with an option for disposable tips. Filters range from 405 nm – 630 nm; dispense volume from 2μL to 1.95 ml; plate washing routines, temperature control, and mixing are programmable. Intuitive software offers on-board predilutions, multiple calibration options, replicates, statistics, QC tracking, barcoded sample ID and data management. Additionally, it schedules assays to prevent timing conflicts while providing optimal throughput. An optional laptop stand conserves bench space.
For more information, visit: www.awaretech.com
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Siemens Healthineers releases free eBook on coagulation testing protocols for COVID-19 patients
, /in Corona News, Product News /by 3wmediaSiemens Healthineers has a released an informative eBook titled “Coagulation abnormalities in COVID-19 patients – current testing and treatment protocols” to provide quick access to coagulation testing and treatment recommendations.
The eBook can be downloaded for free from their website: https://bit.ly/2CcpB5I
Because coagulation tests are important in the management of COVID-19 patients, the company has compiled an eBook for quick access to:
The eBook provides an overview of COVID-19 and thrombosis; it looks at laboratory testing in the identification of coagulation abnormalities in COVID-19 patients; and provides information on the treatment of coagulation abnormalities in COVID-19 patients.
Authors of the eBook write that while it’s not unusual for infections to raise the risk of clotting, the COVID-19 virus is associated with an unprecedented range of clotting-related disorders in affected patients. “From benign skin lesions on the feet to life-threatening thrombotic events, the COVID-19 virus has demonstrated a strikingly high prevalence of deadly blood clots. Studies show that about 25% and even up to 70% of critically ill patients have confirmed venous thromboembolism or pulmonary embolism. Another study found that approximately 70% of COVID-19 patients who died had disseminated intravascular coagulation.”
They add that Siemens Healthineers’s coagulation tests play an important role in the diagnosis, treatment, and management of coagulation abnormalities in COVID-19 patients and point out that the company has changed their production model to produce these assays at a higher volume than ever before.
“We are proud to support you in the fight against COVID-19. Behind every healthcare professional there are 53,000 Healthineers,” Siemens Healthineers says.
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Thermo Fisher Scientific introduces new mass spectrometry systems
, /in Product News /by 3wmediaThermo Fisher Scientific has introduced several new products that build on its leading Orbitrap platform and expand research applications. The new Thermo Scientific Orbitrap Exploris 240 mass spectrometer is designed to give scientists working in proteomics, metabolomics, biopharmaceutical characterisation and small-molecules, the analytical performance required for research and high-throughput analyses. The company says the new system will advance discovery and identification with increased accuracy for confident scale-up, while providing operational simplicity and streamlining time-to-result.
Thermo Fisher Scientific pointed out that the new mass spectrometer delivers qualitative and quantitative capabilities synonymous with Orbitrap high-resolution accurate-mass (HRAM) spectrometry, with internal calibration that assures consistent data quality and decision making. These newest systems extend the Thermo Scientific Orbitrap Exploris portfolio of HRAM systems, which were introduced in 2019 with the release of the new-generation Thermo Scientific Orbitrap Exploris 480 mass spectrometer.
Software
Thermo Scientific Proteome Discoverer 2.5 software provides high confidence during peptide identification, accurate quantification and high throughput data analysis for proteomics researchers. Deep learning-based prediction of tandem mass spectra, facilitated through a new collaboration with MSAID, a software company transforming proteomics through deep learning, enables more scientists to benefit from major improvements in identification confidence and reproducibility.
To further enhance characterisation of protein biotherapeutics and oligonucleotide therapeutics, biopharmaceutical laboratories use the Thermo Scientific BioPharma Finder 4.0 software, which provides greater flexibility and customisation for this growing industry.
For small molecule researchers, Thermo Scientific Compound Discoverer 3.2 software further automates unknown compound identification performed on Thermo Scientific Orbitrap Gas Chromatography- Mass Spectrometry (GC-MS) systems to improve productivity.
In addition, the new Thermo Scientific Xcalibur 4.4 software brings the AcquireX intelligent data acquisition workflow to Thermo Scientific Orbitrap Exploris mass spectrometry platform users, enabling the fully automated acquisition of high quality MS/MS data and reducing manual input and repeat runs.
Collaboration
Thermo Fisher Scientific’s collaboration with Evosep, a leading provider of sample preparation technologies for protein-based clinical research, supports the development of high-throughput clinical research workflows for profiling large plasma sample cohorts for proteomics, translational research and pharmaceutical applications. This partnership recently led to the launch of an automated ultra-high throughput plasma protein profiling platform, combing the power of the new Thermo Scientific Orbitrap Exploris 240 mass spectrometer with the Evosep One liquid chromatography solution.
The company’s collaboration with Biognosys, a leading developer of next-generation proteomics solutions, resulted in the development of data-independent acquisition mass spectrometrybased workflows, which enhances sensitivity and coverage for proteomic research in translational and clinical labs. The collaboration includes a novel FAIMS-DIA method that features the Thermo Scientific FAIMS Pro interface, which improves selectivity, reproducibility and proteome coverage, as well as new methods that streamline discovery by combining Thermo Scientific SureQuant Targeted Assay Kits and the Biognosys PQ500 kit in a single workflow.
For more information, visit: www.thermofisher.com
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