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Archive for category: Product News

Product News

Terumo TERPR001a 15431123

Device to accelerate cell therapy manufacturing

, 26 August 2020/in Product News /by 3wmedia

The Finia Fill and Finish System is a first-of-its-kind device developed to help bring reproducibility and control to cell therapy manufacturing. Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labour-intensive with the added risk of error. The production and delivery of cell-based therapies is a complex and logistically challenging process. Developers and manufacturers appreciate support in determining when to automate, which processes to automate and how to integrate automation into their existing process. Finia combines, mixes and divides the final product into predetermined volumes, all under controlled, refrigerated temperature. It automatically removes air before it seals the final product bags, simplifying the downstream process. Finia also works with Terumo BCT’s Cell Processing Application software in the customers’ network to facilitate compliance to current good manufacturing practices (cGMP), including electronic record-keeping, control of process workflow, user credentialing and permission, and guidance of operators through the process with an intuitive user interface module (UIM).
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Terumo_TERPR001a_15431123.jpg 975 1178 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:46Device to accelerate cell therapy manufacturing
PRODUCT NOVATEC

NovaTec Immundiagnostica’s assays aid diagnosis of SARS-COV-2

, 26 August 2020/in Corona News, Product News /by 3wmedia

NovaTec provides reliable direct pathogen and antibody detection assays to aid in the diagnosis of SARS-CoV-2. These tests are CE-IVD marked. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics, NovaTec Immundiagnostica, and VIROTECH Diagnostics.
The NovaLisa SARS-CoV-2 (COVID-19) ELISA serological assays feature separate detection of IgG, IgA, and IgM antibodies. These three assays use the nucleocapsid protein (N protein) as antigen for the detection of antibodies to SARS-CoV-2, as it plays an important role in viral pathogenesis, replication and RNA packaging. NovaLisa assays can be automated on several open ELISA systems to provide quick results.
The GSD NovaPrime SARS-CoV-2 is a onestep reverse transcription multiplex Real-Time PCR for the direct detection of SARS-CoV-2. The assay simultaneously detects two target sequences inside the N gene. The multiplex PCR enables a streamlined workflow in one reaction and provides results in approximately 2 hours. An extraction/inhibition control and a positive control are included in the kits. The PCR assay demonstrates excellent performance and no cross-reactivity with common human coronavirus strains.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_NOVATEC.jpg 500 768 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:31NovaTec Immundiagnostica’s assays aid diagnosis of SARS-COV-2
NEWS CLI COLOURRFUL 1

Colourful, stretchable silicon lids securely cover open beakers and bottles

, 26 August 2020/in Product News /by 3wmedia

Using aluminium foil or plastic wrap to cap beakers and flasks has always been a quick fix with questionable effectiveness. In an effort to provide lids that are safe and easy to use, DWK Life Sciences, a leading manufacturer of precision labware, has developed KIMBLE® Silicon Lids that stretch and conform to beaker tops for a tight and secure seal.
Available in three sizes and three colours, KIMBLE Silicon Lids easily conform to fit on beakers, flasks, bottles and cylinders. The stretchy silicone material creates a seal on spouts, beaded tops or threaded necks on glass or plastic vessels. The lids are resistant to heat and chemicals and designed with tabs, so they are easy to put on or take off, even when wearing gloves. Dishwasher-safe and reusable, the lids are a sustainable solution for environmentally conscious labs. The lids come in bright colours for easy colour coding.
“We’ve been surprised with the popularity of these unique covers – we knew they were safe, secure and provided a better seal for different laboratory containers, but we were just as happy to see how scientists liked their appearance – they’re using the lids to improve the appearance of the labs by replacing makeshift foil caps and stoppers with bright colours,” said Rick Schwartz, Senior Vice President of Marketing and Sales at DWK Life Sciences. “There is currently no other lab grade product available that remotely resembles our lids.”
KIMBLE Silicon Lids have stretchable diameters; small 43 to 61 mm diameter, medium 64 to 76 mm diameter, and large lids are 84 to 116 mm diameter. Colour choices include pink, green and blue. Lids easily accommodate most 50 ml beakers up to 800 ml beakers. The silicon is resistant to most chemicals and withstands heat with a usable temperature range of 40°C to 180°C. KIMBLE Silicon Lids are sold individually or in packages of 3 containing a small, medium and large sized lid in each package.
For more information, visit: https://dwk.com/colorsplash
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C452 Olympus BX46 clinical microscope

Clinical microscope for routine pathology

, 26 August 2020/in Product News /by 3wmedia

Built to meet the demands of repetitive routine microscopy, the BX46 microscope has features that help the user remain comfortable while working. The stage is fixed so it is close to the desk’s surface, keeping it nearer to the user’s hands. Samples are focused on using the movable nosepiece. The low-position handles and low-torque stage make it easy to move the specimen with a simple finger tap so that the arms and hands rest in a comfortable position. The tube moves up and down, tilts, and extends forward and back. With this one component, users of nearly any height can adjust the scope so that they’re comfortable. The BX46 microscope combines excellent ergonomics with energy efficient LED illumination, which makes it ideal for routine brightfield histology imaging.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C452_Olympus_BX46_clinical_microscope.jpg 600 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:49Clinical microscope for routine pathology
biorad May 29

Bio-Rad introduces new antibodies for in vitro research, commercial applications

, 26 August 2020/in Product News /by 3wmedia

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.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/biorad_May_29.png 378 416 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:34Bio-Rad introduces new antibodies for in vitro research, commercial applications
Beckman Coulter DX Access PCT reagent 563x480 web

Procalcitonin assay for Access immunoassay analysers

, 26 August 2020/in Product News /by 3wmedia

The Access PCT assay is the latest addition to the menu for the Access family of im-munoassay systems. The state-of-the-art sensitivity and low-end precision of Access PCT assay combined with short incubation time helps physicians in the risk assessment of critically ill patients in danger of progression to severe sepsis or septic shock, with test results available in under 20 minutes. Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or septic shock. The ability to rapidly diagnose suspected sepsis patients and determine appropriate care and treatment is critical, as earlier administration of antibiotics is highly correlated with increased patient survival. Access PCT enables healthcare providers to integrate procalcitonin testing analysis into their routine sepsis work-ups on core laboratory analysers, as a primary or reflex test programmed though Beckman Coulter’s REMISOL Advance middleware. Such integration simplifies laboratory workflow and optimizes institutional sepsis management protocols while reducing the operation expense of maintaining costly dedicated instrumentation. The Access PCT assay has received CE mark certification and is avail-
able for use on the Access family of immunoassay systems including the Access 2, UniCel DxI 600 and UniCel DxI 800.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Beckman_Coulter__DX_Access-PCT-reagent_563x480_web.jpg 480 563 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:44Procalcitonin assay for Access immunoassay analysers
C426 Haematex DOAC STOP product image

Direct oral anti-coagulant adsorbent

, 26 August 2020/in Product News /by 3wmedia

DOAC Stop eliminates all direct oral anti-coagulants (DOACs) from test plasmas, making it possible to obtain valid results for all conventional coagulation assays and tests for thrombophilia.  This adsorbent has amazing affinity for DOACs but no effect on clotting proteins, antibodies or heparins. Because it extracts only DOACs, a clotting test result which remains abnormal can be assumed to have other causes.  DOAC Stop minitabs (one/ml) disperse readily in plasma and take less than 5 minutes to bind more than 95% of DOACs in most cases. The adsorbent is quickly removable after it has done its work by centrifugation.  The minitabs work equally well on direct thrombin inhibitors (eg dabigatran) and those against FXa (rivaroxaban, apixaban, edoxaban) and have no effect on heparins or warfarin plasmas.  In most cases DOAC levels can be estimated quickly from the ratio of clotting test results before to after the extraction via an appropriate calibration curve. The best results are obtainable using high phospholipid dRVVT or APTT reagents.

HAEMATEX
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Pantelis Vlachos

Cytel announces East Alloy for easy access to verified Bayesian methods

, 26 August 2020/in Product News /by 3wmedia

Cytel Inc., an advanced analytics leader providing sophisticated quantitative insights to decision-makers in clinical investigation, has launched East Alloy. This new platform is a web-native extension of Cytel’s world-renowned East software for adaptive clinical trial design and analysis.
By leveraging the speed of cloud computing and the pace of SaaS delivery, East Alloy enables easy implementation of computationally intensive Bayesian methods that may be otherwise impractical. The launch of East Alloy builds on Cytel’s time-tested record of delivering cutting-edge Bayesian tools and engines to the pharmaceutical industry for optimized clinical trials.
Bayesian methods are of growing interest to the drug development industry, as they allow clinical investigators to leverage historical trial data as well as learnings from new data as it accrues throughout a trial. The result is better-informed decision making, greater program flexibility, and the ability to run smaller, more resource-efficient trials.
“Our longstanding dedication to adaptive Bayesian approaches means we’re perfectly placed to meet and exceed the growing innovation needs of the pharmaceutical sector,” said Pantelis Vlachos, Director and Strategic Consultant at Cytel. “But it’s key to ensure our customers can practically implement this kind of innovation. East Alloy, reinforced by industry-leading verification, training, and support from Cytel experts, means users can sustainably adopt Bayesian designs to expedite clinical development and overcome uncertainty without compromising scientific rigor.”
The release of East Alloy follows the launch of East Hosted in 2019, which brought Cytel’s East software into the cloud for the first time to simplify the deployment of software updates, reduce on-premise IT burden, and ultimately broaden access to Cytel’s trial design and analysis engines.

  • For more information about Cytel, visit: https://www.cytel.com

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Pantelis_Vlachos.png 772 696 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:28Cytel announces East Alloy for easy access to verified Bayesian methods
iMLayer

Revolutionary sample preparation for MS imaging

, 26 August 2020/in Product News /by 3wmedia

Shimadzu’s iMLayer boosts spatial resolution for MS imaging experiments. It enables reproducible matrix coating with small crystals and minimizes delocalization effects. Get a crystal clear view of microstructures in your sample.
Features

  • Creation of fine matrix crystals by unique matrix vapor deposition technology (sublimation) enabling high resolution MS imaging experiments
  • Minimized delocalization effects compared to conventional spraying method due to sublimation technique
  • Good reproducibility through automated matrix layer thickness control
  • Simple touch pad operation making the easy-to-use standalone instrument a sample preparation tool for any MS imaging experiment

For information please click here.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/iMLayer.jpg 737 958 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:37Revolutionary sample preparation for MS imaging
Bio Rad FCP CLI October

Quality indicator monitors instrument HIL interference detection

, 26 August 2020/in Product News /by 3wmedia

Although your instruments may automatically detect HIL interferences, shouldn’t the lab’s QC program include pre-analytical checks to monitor instruments’ ability to detect them? Studies show that interferences from hemolysed, icteric or lipemic (HIL) specimens are amongst the most common pre-analytical errors.  Liquichek Serum Indices is a quality indicator intended for use as part of laboratory interference testing to monitor an instrument’s ability to detect these three types of samples. Replicating relevant concentrations of HIL interferences using human-sourced materials will allow confidence in the instrument’s performance. With Bio-Rad’s Unity Interlaboratory Program, the user is able to compare instrument responses among peer groups to help avoid costly test repeats. https://tinyurl.com/yxpmoe2e
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Bio-Rad_FCP_CLI_October.jpg 387 542 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:46Quality indicator monitors instrument HIL interference detection
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Bio-Rad - Preparing for a Stress-free QC Audit

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