Powering Diagnostics at Scale

Powering diagnostics at scale Small- to mid-size custom projects eBookIntroduction Each of your molecular or immunoassay development projects is unique. So, you need solutions tailored to your specific needs. Cytiva has a proven track record of delivering innovative diagnostic design and development services. This case study eBook highlights small- to mid-size real-world examples of successful custom service collaborations with diverse clients. From assay design and optimization to high-throughput production and validation, our comprehensive capabilities and technologies can help you overcome challenges and deliver impactful outcomes. Whether you are a scientist or business leader working on or looking to accelerate your diagnostic assay and kit development, you can depend on us. Company size Indicative of the number of employees Indicative of the number of units produced Indicative of the time from project start to completion Indicative of the type of customization provided Project size Time frame Customization type Scope and scale of the project 2 Download our large scale projects eBook Read our customer success storiesRapid scale up of a rapid COVID test Project story • The customer designed a COVID-19 test and needed to quickly scale up production because of the pandemic. • The customer needed contract manufacturing services and was specifically looking to collaborate with a supplier based locally. • The project was difficult because the customer found a functionality problem after launching the project with Cytiva. • The research and development team at Cytiva was flexible and worked with the customer to determine the root cause of the problem. • Even after the project wrapped up, we continued to give them support. • The ongoing support and flexibility from Cytiva impressed the customer so much that they asked us to work with them on four new assays. Company size Project size Time frame Customization type Small Medium 6–8 months Service During the pandemic, everyone was rushing to produce tests, vaccines, and treatments. We had previously met the customer at a conference, so they knew of our experience and capabilities. Happily, we had capacity to take on their project when they needed it. Anish Senan, Diagnostics Account Manager Speak to Anish to learn more: anish.senan@cytiva.com 3 Learn more about our contract manufacturing and kitting servicesTaking the pressure off your glass fibers Project story • When developing tests for the food and beverage industry, the customer found that the Cytiva glass fibers they were using were tearing. • The customer asked us if we could strengthen the fibers without altering their functionality. • The scientists at Cytiva found a way to mechanically reinforce the glass fibers by laminating the fibers with a substance that absorbed the force on the fibers. • The customer received multiple prototypes, had direct access to the Cytiva scientists, and received continual updates. • We had to work with supply chain issues due to the COVID-19 pandemic, and the customer was pleased with the final product and continues to source their fibers from us. The customer was already using Cytiva glass fibers, but our product didn’t measure up to the criteria they had for a particular test. They appreciated the fact that we were able to do this small-scale custom product, particularly because the fibers worked in every other way already. Dominik de Cassan, Site Leader Research and Development Speak to Dominik to learn more: dominik.decassan@cytiva.com Company size Project size Time frame Customization type Small Medium 9 months Product 4 Get in touch to discuss your immunoassay rapid test component needs Saving customer time with contract kitting Project story • The customer developed an immunodiagnostic kit for a specific disease that predicts a patient’s disease course and can be used to recommended treatment plans. • The customer came to Cytiva for help packaging the product. • All parts of the kit were supplied by the customer, and Cytiva assembled the final kit in a compliant way. The completed kits were shipped back to the customer ready to be distributed. • Though the packaging process was not difficult, made business sense for the customer to outsource this to a company with scale and capability in this area. • The team at Cytiva found a way to optimize the assembly process and deliver the kits to the customer faster. • The customer plans to continue to work with Cytiva as they scale up production. Company size Project size Time frame Customization type Small Small 4 months, ongoing Service Assembling and packaging materials is not the most exciting part of the immunodiagnostic kit development process, but it needs to be done. At Cytiva, we are more than happy to take on this tedious task so that our customers can spend their time on strategic tasks. Anish Senan, Modality Sales Diagnostics Account Manager Speak to Anish to learn more: anish.senan@cytiva.com 5 Learn more about our diagnostic services Dealing out lateral flow test cards Project story • The customer needed a company to produce preassembled lateral flow cards that they could put into their diagnostic kits. • Cytiva worked closely with the customer. We sent regular updates and prototypes and met all the customer-set timelines. • However, it became clear that the product was not performing as expected. • Our scientists communicated directly with the customer and helped them troubleshoot the issues with the product. • The customer appreciated the fact that Cytiva had the experience and knowledge to discover why the product wasn’t working and that we were willing to share this knowledge with them. • We were able to complete validation of the product. Company size Project size Time frame Customization type Small Small 5 months Product The customer chose to work with Cytiva because we are happy to provide custom products and services to small-volume companies. This willingness is rare among other large custom service companies. Dominik de Cassan, Site Leader Research and Development Speak to Dominik to learn more: dominik.decassan@cytiva.com 6 Learn more about our immunoassay development services Packaged for you in the perfect plastic Project story • The customer had a new product for early cancer detection. • Cytiva magnetic beads worked well with the customer’s product, but the beads were not supplied with the optimal buffer or in the correct container. • The customer asked Cytiva for a custom product that used the correct buffer and had the beads loaded in a 96-well plate. • Cytiva and the customer had regular meetings and site visits, and Cytiva did audits for the customer. • The customer was happy that they had direct contact with the scientists working on the project and that they had access to technical experts when needed. • Cytiva’s flexibility in working with the customer was also praised. The customer liked the performance of our magnetic beads, but we didn’t provide the beads in the format that like wanted. For one thing, they wanted the beads in a 96-well plate. We’d never done that before with our mag beads. But we did it. We made exactly what the customer wanted. Math Davies, Custom Service Leader Speak to Math to learn more: matthew.davies@cytiva.com Company size Project size Time frame Customization type Small Medium 18 months Product 7 Learn more about our magnetic bead conjugation services Made-for-you membrane with QC and COA Project story • The customer was using an existing Cytiva membrane while developing a diagnostic test. • The membrane’s specifications were not tight enough for the customer’s needs, so they asked us to improve it. • The customer did not know the root cause of the problem and left it for Cytiva scientists to discover and eliminate. • Cytiva scientists made changes to the membrane and provided validation products for the customer to test. • The customer then wanted additional quality control (QC) done on the membrane. • After the QC, Cytiva provided a custom certificate of analysis (COA) and all specification and work instruction documentation. Company size Project size Time frame Customization type Medium Medium 3 months Product and service Like so many other companies, the customer was trying to develop a COVID-19 antigen test. Of course, time to market was extremely important. We kept in constant contact with the customer. We even checked up on their internal testing to make sure everything was going smoothly on their side. Sarah Zachmann, Senior Diagnostic Scientist Speak to Sarah to learn more: sarah.zachmann@cytiva.com 8 Request a sample of our point of care flow based immunoassay components More information Powering diagnostics at scale Large custom projects eBook 9 Checklist: 10 essentials for choosing a collaborator for diagnostic assay Download our large scale projects eBookcytiva.com Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. or an affiliate doing business as Cytiva. © 2023 Cytiva For local office contact information, visit cytiva.com/contact CY37002-07Jul23-EB