Diagnostic assays like the one you’re developing are in demand. But your task isn’t simple. Set yourself up for success by choosing a supplier with quality products across your workflow and the capabilities needed to help commercialize your assays.
When you’re developing a diagnostic assay, access to reliable suppliers with relevant technology is a must. However, other attributes are key in accelerating the journey to bring your product to commercial success.
Consider a supplier’s procurement, supply timelines, and infrastructure. Another important factor is the availability of ongoing service and support, including help to ensure regulatory compliance.
Here, Chris Kuhlmann and Martina Kahl from Cytiva answer common questions. They share their insights from working with companies developing and manufacturing molecular and immunodiagnostic kits and assays.
Developing a novel diagnostic technology is a highly involved process. Although the initial concept and lab-based development might have gone exceptionally well, there’s more to consider when transferring the science to a commercial diagnostic product.
Chris explains, “Having great technology is only the first step in the process. Developing a diagnostic technology with the goal of commercial success requires a number of phases from optimization, verification, and validation to scale-up and manufacture. The intricacies of these steps will depend on the type of diagnostic technology being developed. For example, a lab-based molecular diagnostic assay will need to meet a different set of specifications compared to a lateral flow device (LFD) intended for home use.”
She adds, “Throughout the development cycle, you need to carefully select key raw materials and ensure they are suitable for their use. This doesn’t just mean that the materials are compatible but also that they show consistency, can be easily and reliably sourced, and are available in quantities needed for scaled-up manufacturing, for example.”
Suppliers play a key role in helping diagnostic companies succeed at bringing their products to market. Martina discusses some of the key criteria to consider when choosing a supplier, “Price is an important factor when sourcing raw materials; however, it is better to focus on value for money. Cheap suppliers don’t always represent the best value for money. Cutting costs on key raw materials can manifest as increased costs downstream if quality and reliability are compromised.”
She continued, “Equally, the cheapest option may not always offer the best service. For example, security of supply is fundamental. Late deliveries can severely impact your development timeline and can lead to letting your customers down at the commercialization stage.”
Chris adds, “Ultimately, a supplier that aims to work collaboratively with you underpins a good choice. Consider whether they have the knowledge and expertise to help you with the development process, the scalability to see you through to manufacturing stages, and the flexibility to continue meeting your objectives when your needs become more specialized.”
“Working with a single supplier for your diagnostics requirements has numerous advantages,” explains Martina, “Generally, it reduces the complexity of the supply chain and also saves you time and resources since you only need to validate one supplier. Additionally, you may be able to negotiate better services or terms when placing large orders due to economy of scale.”
Chris comments that working with Cytiva as your single diagnostics supplier brings some additional benefits: “The needs of a Dx company typically transcend the typical supplier/buyer relationship. At Cytiva, we strive to forge trusted collaborations with our customers that exceed simply supplying high-quality products.” And it’s a huge bonus when your supplier also has well-established products to produce, purify, and analyze the antibodies or other molecules used in your assays.
Chris adds, “For instance, recently, we have been working with a Dx company that were developing a saliva-based lateral flow device. The company needed to produce and purify affimers — small proteins that bind to target antibodies — for their device. Ultimately, they chose to make the affimers in a ReadyToProcess WAVE™ bioreactor and purify them using an ÄKTA™ chromatography system, both from Cytiva. This process was not only fundamental to the development of the lateral flow device but was also scalable, and so now supports full-scale manufacturing. Moreover, our lateral flow immunoassay development services were able to provide expertise and support across this client’s workflow, from initial development and clinical trials to manufacturing and commercialization.”
The company has a wide portfolio of diagnostic products and services that spans both molecular and immunodiagnostics. This allows diagnostic developers and manufacturers to consolidate multiple orders and work with a single supplier as much as possible.
And Cytiva offers a scalable, secure supply of high-performance pads and membranes from the Whatman™ portfolio. This range includes high-quality products for development and manufacture of lateral flow assays, flow-through immunoassays, and dipstick colorimetric assays.
Martina describes how the company helps to drive forward diagnostic technologies: “I think what sets us apart is manifold. Firstly, we have a global infrastructure and network coupled with ongoing supply risk management strategies to ensure that our customers feel confident that their supply won’t be interrupted. Moreover, delivery can be consolidated, simplified, and timelines managed more easily.”
She continues, “Also, the broad portfolio of products – for diagnostics and for producing and analyzing molecules used in the assays – is married with a diverse range of experience and know-how. This ensures that customers have access to support and advice across multiple parts of their workflow. This can be particularly important when troubleshooting linked protocol steps. In other words, sourcing from a single supplier makes it easier to identify the source of any issues, and it allows a single point of contact for advice.”
Chris adds, “We can also collaborate with customers to provide bespoke, customized solutions, including Lyo-Stable™ lyophilization services. Whether creating a custom bead, a specialized enzyme, or optimizing the design of your complete diagnostic platform, our team can help you meet your specific objectives. Our committed and specialist service revolves around collaboration and responsiveness to help accelerate your diagnostic development process.”