Diagnostic services: value added services (part 1)

Custom diagnostic services can accelerate the development and manufacture of your diagnostic assays. In part one of our blog series, learn about our value-added services: lyophilization, custom conjugated magbeads, and contract manufacturing.

---

Lyo-Stable™ lyophilization services

Lyophilization is a freeze-drying process (also known as cryodesiccation) that removes water from a sample or product by freezing and placing it under a vacuum. It is done in three stages and results in a dry powder with almost all the water removed from the starting product (Fig 1). The lyophilized powder is much lighter in mass and smaller in volume than the original product or sample. Readying this lyophilized powder for use then simply involves adding sterile, distilled water or an appropriate buffer to form a solution in a process called reconstitution.

Fig 1. The process of lyophilization involves three stages that remove water from a sample by freezing it and placing it under specific vacuum pressures and temperatures.

After the components of a diagnostic assay are lyophilized, they can be combined into a single tube. The result is a pre-dispensed, single-dose reagent that vastly simplifies assay setup (Fig 2). Using this lyophilization approach, scientists do not need to individually pipette microliter quantities of potentially expensive assay reagents, greatly simplifying their workflows. The robustness and reliability of an assay are also improved along with data quality and sustainability. Furthermore, the risk of sample contamination is minimized.

Read more about the advantages of lyophilization in our knowledge article.

Fig 2. A complete assay in a single tube. Example of components for an amplification-based custom Lyo-Stable™ service formulation.

It is often not practical for laboratories to perform their own lyophilization because it requires a large capital investment with the purchase of complex equipment, including the freeze dryer itself. Obtaining the intended chemical or biological integrity and activity with every batch is also a challenge. Each product and sample are unique, requiring an optimized freeze-drying cycle and excipient formulation, which can take time and effort to determine.

Our patented Lyo-Stable™ processes enables you to avoid these expensive outlays and still benefit from all the advantages that come with lyophilization. This lyophilization technology can be applied to stabilize individual proteins and reagents, as well as complete multiplex assays, by providing a molecular environment that protects against conformational changes in protein structure. From simple buffers to multicomponent kits, our custom stabilization team can develop and manufacture custom products in small or large batch sizes to meet your requirements.

Read more about custom lyophilization services

Custom magnetic bead conjugation services

Magnetic beads (or magbeads) can be used for the isolation and purification of cells, nucleic acids, proteins, or any other biomolecules. The surface of magnetic beads can be coated in a variety of ligands to bind a specific target molecule. By exploiting this type of surface modification, magnetic beads offer an exceptionally versatile tool for biomolecule isolation. Because of this versatility and their ease of use, magbeads are often part of diagnostic assays.

Magbeads can be conjugated with a wide variety of ligands due to the variety of different composition, surface chemistry, and size possibilities of beads. Ligands can be bound covalently and noncovalently and link either directly to the bead surface or indirectly through a reactive intermediate. Figure 3 shows a few possible functionalization examples including common functional groups, proteins, antibodies, and nucleic acids.

Fig 3. Magnetic bead surface functionalization examples

Cytiva has a broad portfolio of magnetic beads with different surface chemistries, speeds, and surface structures. But even with all these options, it’s impossible to cover every need and eventuality. That’s where custom conjugation comes in. Custom conjugation optimizes reagents and magnetic beads using concentration, reformulation, binding and adaption of particle sizes and functionalities.

But you may find that doing custom conjugation in-house is not possible. Your team might not have the skills or knowledge to make the beads, or you may simply not have the time to develop and produce the beads you need at the scale you need. You also may not know how to optimize the beads for your use in terms of concentration and formulation. That’s when you can turn to us.

We offer a custom magbead conjugation service.. Our experienced team will work closely with you to develop and produce the beads that best fit your needs.

The many ways you can have beads customized include:

• Conjugation: enzymes, antibodies, and custom ligands
• Concentration: particles and reagents over a wide range of concentrations
• Formulation: modifications to buffer composition, containers, dispense volumes
• Custom particles: nonstandard sizes or functionalities

Find out about custom conjugation services

Contract manufacturing services

After you’ve developed your assay, you’re ready to commercialize. But do you have the infrastructure, capacity, and supply network of raw materials to help you get there? We can help.

Acquiring specialized infrastructure requires capital investment, time to implement, and potentially staffing up, or up-skilling existing staff. Contract manufacturing converts this to an expense, part of the cost of goods. You can use our infrastructure when and how you need it. With global facilities capable of accommodating manufacture of simple buffers through to multicomponent kits for both low and high throughput customers, we can comfortably manufacture your specific product for use in diagnostic applications.

Our reagent and kit manufacturing allows you to take advantage of our team’s extensive knowledge and experience in sourcing and validating raw materials, and our ISO certified manufacturing facilities. A dedicated team will guide you through the process of developing your minimum viable product to a commercial product from the initial proof of concept through to batch validation and into production. Our methodology and processes are designed with the aim of ultimately creating a seamless transition to large scale manufacturing to meet the desired quality standards.

Our contract manufacturing services include:

• Assay validation
• Formulation
• Kitting capability, including assembly and packaging
• Analytical services
• Final product testing
• Product design capability

Learn more about contract manufacturing

Look to Cytiva Diagnostic Services

No matter where you are in your molecular or immunodiagnostic assay development, we have highly experienced, specialized teams ready to help you. We’ve worked on projects big and small. We’ve done everything from customizing a single assay component to developing a kit from start to finish. Lyophilization, custom conjugation, and contract manufacturing are just some of the custom services that we offer.

By engaging with our Diagnostic Services team, you’ll be in safe hands. For example, we protect your intellectual property as carefully as we protect our own. We also understand that security of supply is extremely important, so we take a proactive approach with a comprehensive raw material supplier risk management program. The risk management program:

• Reduces the number of high-risk suppliers
• Mitigates risk through improved knowledge and assessment of potential incidents
• Uses the most resource effective activities to reduce supplier risks
• Establishes multi-sourcing and multi-manufacturing options for critical materials

Let us help you accelerate your diagnostic assay development and manufacture.

Part two of our Diagnostic Services blog series covers custom solutions, and part three covers knowledge and experience sharing.

Find out what Diagnostics Services can do for you