Molecular Diagnostic Assay Development with Dynabeads Plus

This 7 part diagram shares the value beyond the Dynabeads product from Security of supply to Analytics to Access to commercial rights

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Dynabeads have helped our partners launch tests in a wide range of molecular applications, such as infectious diseases, animal health, reproductive health, and oncology. Some of the products are from our existing bio-discovery portfolio, while others are developed and supplied on an OEM basis. Dedicated kits have been developed for isolation of viral nucleic acids and genomic DNA.

Learn more about how we can support your assay

How have Dynabeads Plus helped Molecular Diagnostic development?

See an example of working with Dynabeads and molecular diagnostic products to measure the impact of radiation exposure.

Customer need

How Dynabeads Plus helped

Results

Government funding for FDA clearance contingent on ability to supply kit
Significant product customization required
Need a tool for measuring response to ionizing radiation

The Dynabeads Plus team initiated multiple meetings at the customer site to develop product transfer and validation process, beginning with a quote and ending with a long-term supply agreement.

Validated process for new product size and concentration
Secured contract with government and FDA clearances

Dynabeads molecular diagnostic product benefits include

High capacity and wide dynamic range
High signal-to-noise ratio
Adaptable to any known detection method and assay methodology
No magnetic remanence

Reproducible automated behavior without mixing
Fast and efficient washing
Increased sensitivity
Easy handling in manufacturing and shortened assay development time

Assay lifecycle support

Feasibility

Dynabeads Plus support

Evaluation of multiple products at small-scale.

Product performance

Samples of different bead types
Samples coupled with antibody/antigen for rapid screening
Training and tech support
Customized protocols

Development

Dynabeads Plus support

Evaluation of multiple products at small-scale
Further investigations with selected product

Product performance

Samples of different bead types
Samples coupled with antibody/antigen for rapid screening
Training and tech support
Customized protocols
Material for robustness
Borderline material
Flexible volumes
Customized products

Technical service and support

Tech support, customer projects, and seminars, scale up support

Production

Dynabeads Plus support

Evaluation of multiple products at small-scale
Further investigations with selected product
Validation of material using several (diverse) batches

Product performance

Samples of different bead types
Samples coupled with antibody/antigen for rapid screening
Training and tech support
Customized protocols
Material for robustness
Borderline material
Flexible volumes
Customized products
Material for validation using multiple batches
True batch variation and batch allocation
Up-scaling
Upgrade bead process to IVD standard
Safety stock solutions

Technical service and support

Tech support, customer projects, and seminars, scale up support
Joint Kaizen to remove waste & strengthen partnership

Post-launch

Dynabeads Plus support

Evaluation of multiple products at small-scale
Further investigations with selected product
Validation of material using several (diverse) batches
Supply of material for use in regular manufacturing

Product performance

Samples of different bead types
Samples coupled with antibody/antigen for rapid screening
Training and tech support
Customized protocols
Material for robustness
Borderline material
Flexible volumes
Customized products
Material for validation using multiple batches
True batch variation and batch allocation
Up-scaling
Upgrade bead process to IVD standard
Safety stock solutions
Supply security, SLA
Contingency planning
Automation for supply security

Technical service and support

Tech support, customer projects, and seminars, scale up support
Joint Kaizen to remove waste & strengthen partnership
Logistic and production overview

Dynabeads products that support molecular diagnostic assay development

Product	Characteristics	Selected applications
Dynabeads MyOne SILANE	Monosized beads with an optimized silica-like surface chemistry Highly reproducible binding of both DNA and RNA High specific surface area (approx. 20 m²/g) Size: 1 micrometer, monodisperse Isoelectric point: pH 3.5 Increased iron content compared to the traditional Dynabeads MyOne product range, and hence a better mobility to magnet Low sedimentation rate and favorable reaction kinetics Flexible starting volumes	Isolation of total nucleic acids (DNA/RNA) From biological samples (serum/plasma, human whole blood etc.) Well suited for automated applications Validation and customization (bead, buffer, protocol or format) available upon request. Adjusted to customer requirements on a custom OEM basis
Dynabeads SILANE viral NA	Contains Dynabeads MyOne SILANE (see above for characteristics), buffers and a protocol optimized for isolation of viral DNA/RNA High sensitivity for viral DNA and RNA, e.g. can detect HBV DNA in a 200 µl serum sample containing only 40 infectious units	Isolation of viral DNA/RNA from human serum/plasma samples Effective isolation of nucleic acids even from challenging viruses (e.g. HBV)
Dynabeads SILANE genomic DNA	Contains Dynabeads MyOne SILANE (see above for characteristics), buffers and a protocol optimized for isolation of genomic DNA High integrity and purity of isolated DNA Typically isolates 10 µg DNA from a 350 µl blood sample using 50 µl (2 mg) Dynabeads Linear range of DNA yield relative to white blood cell (WBC) counts	Isolation of genomic DNA from human whole blood From fresh/frozen blood samples, and with a wide range of anticoagulants
Dynabeads Oligo(dT)₂₅	Hydrophilic bead surface Size: 2.8 micrometer Iron content (ferrites): 14% (20%) Amount of coupled oligo-dT₂₅ probe: 70 pmol/mg beads Capture of polyA mRNA: >2 µg/mg beads	Capture of polyA+ mRNA directly from crude starting samples Build a solid-phase cDNA library Specific capture of nucleic acid targets (using capture probes with oligo-dA tail)
Dynabeads M-270 Streptavidin	Hydrophilic bead surface Based on carboxylic acid beads Size: 2.8 micrometer, monodisperse Isoelectric point: pH 4.5 Highly charged (-50 mV, at pH 7) Iron content (ferrites): 14% (20%) Low aggregation of beads in high salt solutions Free biotin binding: 650–1,350 pmoles/mg beads Binding biotinylated Ig: 5–10 µg/mg beads	Isolation of biotinylated molecules Sequence specific DNA/RNA capture in nucleic acid based diagnostics Preparation of single-stranded DNA. For use in protocols that require GTC lysis or high salt concentrations, or protocols not compatible with BSA. Immunodiagnostics with hydrophobic targets
Dynabeads M-280 Streptavidin	Hydrophobic bead surface Based on tosylactivated beads Size: 2.8 micrometer, monodisperse BSA as blocking protein Isoelectric point: pH 5.0 Low charge (-10 mV, at pH 7) Iron content (ferrites): 12% (17%) Free biotin binding: 650–900 pmoles/mg beads Binding biotinylated Ig: 5–10 µg/mg beads	Isolation of biotinylated molecules Sequence specific DNA/RNA capture in nucleic acid based diagnostics Purification of DNA/RNA binding proteins Protein purification, phage display and biopanning Immunodiagnostics
Dynabeads MyOne Streptavidin C1	Hydrophilic bead surface Based on carboxylic acid beads (C1) Size: 1 micrometer, monodisperse No blocking proteins used Tween 20 in the buffer Isoelectric point: pH 5.2 Medium charged (-35 mV, at pH 7) Iron content (ferrites): 26% (37%) Low sedimentation rate and improved reaction kinetics compared to M-280/M-270 beads Very low aggregation Free biotin binding: >2,500 pmoles/mg beads Binding biotinylated Ig: 20–25 µg/mg beads	Isolation of biotinylated molecules Sequence specific DNA/RNA capture in nucleic acid based diagnostics Preparation of single-stranded DNA High throughput nucleic acid clean-up protocols Well suited for automated applications
Dynabeads MyOne Carboxylic Acid	Hydrophilic bead surface with carboxylic acid groups Size: 1 micrometer, monodisperse Iron content (ferrites): 26% (37%) Low sedimentation rate and improved reaction kinetics compared to M-280/M-270 beads Very low aggregation Active chemical functionality: 0.6 mmol/g beads Coupling capacity: 20–25 µg proteins or 700 pmol oligonucleotides per mg beads	Immobilization of amino-modified oligonucleotides, antibodies or other ligands, for capture of specific DNA/RNA sequences, proteins or any other analyte Well suited for automated applications
Dynabeads M-270 Carboxylic Acid	Hydrophilic bead surface with carboxylic acid groups Size: 2.8 micrometer, monodisperse Iron content (ferrites): 26% (37%) Very low aggregation Active chemical functionality: 150 µmol/g beads	Immobilization of amino-modified oligonucleotides, antibodies or other ligands, for capture of specific DNA/RNA sequences, proteins or any other analyte Well suited for automated applications
Dynabeads MyOne Tosylactivated	Hydrophobic bead surface Size: 1 micrometer, monodisperse Iron content (ferrites): 26% (37%) Low sedimentation rate and improved reaction kinetics compared to M-280/M-270 beads Active chemical functionality: 0.04–0.06 mmol/g beads	Immobilization via primary amino- or sulfhydryl groups. Protein purification, phage display and biopanning Immunodiagnostics
Dynabeads M-280 Tosylactivated	Hydrophobic bead surface with p-toluene-sulfonyl (tosyl) groups Size: 2.8 micrometer, monodisperse Iron content (ferrites): 12% (17%) Active chemical functionality: 0.1–0.2 mmol/g beads	Immobilization via primary amino- or sulfhydryl groups Protein purification, phage display and biopanning Immunodiagnostics

Benefits of partnership

There’s a reason Thermo Fisher Scientific already works with some of the world’s leading diagnostic companies.

Premium products: All Dynabeads products are validated with a unique level of reproducibility within and between batches. Patented manufacturing processes ensure careful control of bead parameters and product properties, securing their performance.

Unrivaled bead manufacturing: World-class manufacturing facilities can manufacture batches ranging in size from 1 g up to 2 kg with close to zero off-grade batches and flexible production scales. This meets relevant regulatory and quality systems compliance.

Comprehensive technical support: Extensive proprietary knowledge enables customized product development, decreases quality control costs, and increases manufacturing efficiency with hands-on support from R&D scientists.