Diagnosticgrade – because RUO and IVDR do not fit together
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With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:
Detail
Diagnosticgrade – because RUO and IVDR do not fit together
This unique quality seal ensures high quality and performance of raw materials ideally suited for use in development projects for IVD
With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:
IVD manufacturers can obtain reagents developed and produced by myPOLS Biotec under ISO 13485.
We offer you the quality and safety that the IVDR requires from suppliers – these are, for example, control of suppliers via quality assurance agreements, information about changes, consent to audits.
The Johner Institute provides structured templates for the documentation of your product verification with clear and brief explanations of how to complete them.
Both cooperation partners express with the DiagnosticGrade seal that the reagents meet the relevant requirements and thus ensure the maturity level for diagnostics.
Diagnsoticgrade facilitates the development of new IVD assay products for IVD manufacturers and enables IVDR compliance of existing kits.
Nucleic acid testing (NAT) is the method of choice for detection and quantification of a wide range of micro organisms. Primerdesign manufactures and supplies high quality quantitative real-time PCR kits for the detection and simultaneous quantification of numerous significant pathogens . A copy number standard curve is provided for quantification and an the internal extraction template (DNA or RNA), controls for the quality of the nucleic acid extraction and eliminates false negative results.
The kit is designed with the broadest possible detection profile to ensure that all clinically relevant strains and subtypes are detected. Target sequences are selected by working with data from key opinion leaders in the field. Multiple sequence alignments and unprecedented real-time PCR expertise in design and validation ensure the best possible kit.
Details of the target and priming specificity are included in the individual handbooks above.
Packaged, optimised and ready to use. Expect Better Data.
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Exceptional value for money
Rapid detection of all clinically relevant subtypes
Positive copy number standard curve for quantification
Highly specific detection profile
High priming efficiency
Broad dynamic detection range (>6 logs)
Sensitive to < 100 copies of target
Accurate controls to confirm findings
SMOBIO’s B-BOX™ is a long wavelength, blue light LED epi-illuminator. It is compact in design and robust in structure. The B-BOX™ epi-illuminator provides an unprecedented level of safety for its user due to its non-UV light source and a low operating voltage of only 12 Volts, as well as its capability working with non-carcinogenic DNA/ protein dye. The B-BOX™ comes with high quality non-flickering LED light that is highly sensitive for DNA and protein dye. B-BOX™ can greatly ease the routine chore of gel extraction, enabling easy visualization and gel cutting even in bright ambient light. The multi-angle filter plate (Cat. No. VE0102) provides optimal angles for gel cutting, visualization, and documentation. The B-BOX™ also comes with amber colored filter goggles (Cat. No. VE0103) for gel cutting and visualization. The Phox™ Photobox (Cat. No. VE0104) provides a mini darkroom environment for images taken with any smartphone. Finally, a built-in barrier system around the working area helps facilitate cleaning.
Features
Improved cloning efficiency
Compact, lightweight, and portable (less than 1 kg in weight)
Safety features include : 470 nm long wavelength, without any UV radiation hazard to its user
Compatible with non-carcinogenic, non-ethidium bromide DNA staining dye
User friendly: Samples are easy to visualize (when using the filter plate or goggles)
LED light source lasts up to 50,000 hours
Superior detection sensitivity: ≤ 0.04 ng of DNA when using FluoroStain™ DNA Fluorescent Staining Dye, ≤3 ng of protein when using FluoroStain™ Protein Fluorescent Staining Dye (as sensitive as silver stain)
Adjustable and removable filter plate allows for gel cutting, visualization, and documentation
Built-in barrier design, for easy clean up
Visible in bright ambient light
Emphasizes minimal power reliance, low heat generation, with its own built-in heat sink
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SMOBIO’s B-BOX™ is a long wavelength, blue light LED epi-illuminator. It is compact in design and robust in structure. The B-BOX™ epi-illuminator provides an unprecedented level of safety for its user due to its non-UV light source and a low operating voltage of only 12 Volts, as well as its capability working with non-carcinogenic DNA/ protein dye. The B-BOX™ comes with high quality non-flickering LED light that is highly sensitive for DNA and protein dye. B-BOX™ can greatly ease the routine chore of gel extraction, enabling easy visualization and gel cutting even in bright ambient light. The multi-angle filter plate (Cat. No. VE0102) provides optimal angles for gel cutting, visualization, and documentation. The B-BOX™ also comes with amber colored filter goggles (Cat. No. VE0103) for gel cutting and visualization. The Phox™ Photobox (Cat. No. VE0104) provides a mini darkroom environment for images taken with any smartphone. Finally, a built-in barrier system around the working area helps facilitate cleaning.
M-SAN HQ – Peak performance where it matters most at physiological conditions
Medium-Salt Active Nuclease High Quality (M-SAN HQ) is a Bioprocessing Grade nuclease developed for removal of both single and double-stranded DNA and RNA at the physiological salt conditions most often used in bioprocessing and biomanufacturing workflows. M-SAN HQ allows you to directly replace Benzonase without changing your workflow.
This novel, nonspecific endonuclease is active over a broad pH range and displays optimum activity at salt concentrations between 125 – 250 mM. Due to its excellent performance at physiological conditions, M-SAN HQ can be used directly in the cell medium or the harvested supernatant without buffer adjustments. This makes M-SAN HQ ideal for the manufacturing of fragile vectors such as lentiviruses and retroviruses.
M-SAN HQ can be directly used in medium without buffer adjustments The high activity of M-SAN HQ at standard cell medium conditions leads to improved DNA clearance compared to other commonly used nucleases. In the data (see Figure 6), an over 2-fold reduction in residual DNA was achieved.
Key Benefits
Compatibility: Ideal for working with both fragile and robust viral vectors and proteins in a variety of cell media
Optimum activity: Optimization for cell media salinity allows both shorter DNA fragments and reduced incubation times.
Cost-Effectiveness: Reduced need for additional reagents and steps can lower production costs
Quality: Maintains the integrity of sensitive or labile biological molecules, ensuring a higher quality end product
Flexibility: Can be used directly in a variety of media without the need for customization
Key Features
High purity (≥ 99%)
No protease detected
Endotoxin-tested
Animal origin-free production
Supplied with extended product documentation
Adapted to use in medium without salinity adjustments
Optimal activity at physiological salinity and pH makes it ideal for DNA removal from mammalian cell media. (see Figures)
The high activity of M-SAN HQ at the physiological salinity and pH found in standard cell medium conditions leads to improved DNA clearance compared to commonly used nucleases.
Simple to Optimize in Cell Media
M-SAN HQ is uniquely formulated to excel in physiological pH conditions, offering high performance at the commonly used cell media pH of 7.4.
While other nucleases often require more alkaline environments, M-SAN HQ stands out for its adaptability and effectiveness in cell media. It’s the nuclease that truly aligns with your bioprocessing needs. (See Figure section)
M-SAN HQ ELISA Kit
The M-SAN HQ ELISA Kit confirms the removal of M-SAN High Quality in bioprocessing and biomanufacturing applications with high accuracy:
Medium-Salt Active Nuclease High Quality (M-SAN HQ) is a Bioprocessing Grade nuclease developed for removal of both single and double-stranded DNA and RNA at the physiological salt conditions most often used in bioprocessing and biomanufacturing workflows. M-SAN HQ allows you to directly replace Benzonase without changing your workflow.
