Establishing a dedicated space in China for diagnostics companies to work through challenges and ultimately bring tests to market faster.
“In the last year, China has been extremely active. They accelerated the development of their COVID-19 tests and we see a lot of demand for diagnostic components,” says Emmanuel Abate, VP Genomics and Cellular Research at Cytiva.
We are opening a new design lab in Tonglu, our manufacturing site, close to Shanghai in East China. Here, diagnostics companies can access Cytiva’s diagnostic services without having to travel overseas to our other design lab in Germany. Developing a lateral flow diagnostic is a complex process. By offering laboratory infrastructure, technical expertise, and consultation we help developers overcome technical hurdles and be ready to apply for regulatory approval.
The new lab is part of Cytiva’s global expansion plans, an investment of 500 million USD over five years to raise manufacturing capacity, announced in September 2020.
Above: From raw material selection to scale-up, our experts are ready to guide diagnostics companies through R&D challenges.
A tailored service model
To develop a sensitive, reliable point-of care diagnostic assay is complicated. Developers need to draw upon expertise in diverse areas such as material science, biochemistry, and virology, as well as manufacturing for scale-up. This is what we are bringing under one roof with our design lab. Every company faces different challenges and that is why our offering stretches across the development process. We offer:
- Raw material research advice. Helping you decide whether to develop a lateral flow test, dry chemistry/dipstick or flow through immunoassay test for your diagnostic application.
- Scale-up support. Assisting all the way from R&D prototype to manufacture set up, advising how to make the development process as efficient as possible without compromise.
- Access to the lab. Fitted with sample preparation equipment, bench-top centrifuges and refrigerated centrifuges, electronic scanning microscope, new gold spraying/striping equipment and a lateral flow reader.
Above: Scientists at the lab work in Tonglu, situated in East China, a World Class Manufacturing site for filter paper.
“We have been manufacturing filtration products in Tonglu for many years and are now pleased to apply our assay design expertise to help local companies with their diagnostics projects. The expectations of this new lab are high and there are already a dozen design-in projects in this year’s pipeline.” says Eric Wu, Plant Manager for the Tonglu site.
Our Tonglu site is a World Class Manufacturing site for filter paper. Powered by over 200 associates and a culture of continuous improvement, the site is ISO-accredited with digital and automation technologies. The new lab strengthens our commitment to the Tonglu area, an economic development zone.
“We have been supporting the diagnostic industry for over 30 years', helping customers to optimize assays,” says Emmanuel Abate. “With lots of new companies entering the space to meet the challenges of COVID-19 now is the right time to establish a dedicated space to support our customers in Asia to reach their diagnostics development goals.”
Read more about Cytiva Diagnostic Services for early-stage rapid point-of-care immunoassay development here.
In addition to immunoassay development services, we offer a range of solutions to simplify your molecular and immunodiagnostics workflows. These solutions include lyophilization, conjugation, contract manufacturing, custom biology and custom plates. Whether creating a custom magnetic bead, a specialized enzyme, or a convenient kit, we develop your minimal viable product to assess functionality, stability and appearance, followed by proof-of-principle studies to optimize the product and ensure that we can scale the product up and meet quality standards. Tailored to your precise specifications, our custom diagnostics products deliver reliable performance with lot-to-lot consistency assured. Find out more.