The Asia Diagnostics Advanced Application Center has been set up to provide companies with expertise and lab infrastructure to help them overcome technical hurdles and to be ready to apply for regulatory approval, according to the life sciences company.
The China based lab means that local diagnostics companies can now access Cytiva’s diagnostic services without having to rely on the company's other design lab in Germany, it added.
This new lab is part of the spend Cytiva announced in September 2020, with it allocating US$500m to realize its goal of raising overall manufacturing capabilities within five years. With a lot of new companies entering the diagnostics field over the last 12 months to address the challenges of the COVID-19 pandemic, Cytiva has been investing in new and existing sites and services to support that surge in capacity.
Duplicating the European model in Asia
Emmanuel Abate, vice president genomics and cellular research at Cytiva, speaking to BioPharma-Reporter last October, debriefed us on the company’s plans for China and told us that, globally, it had been seeing “a lot of smaller firms – biotech companies and innovators - coming with their kits and asking for help. To that extent, apart from capacity for components, we decided to invest in service labs so that we can partner with those diagnostic companies. While we have been doing that work for many years, it has mostly been in one location; now we are expanding to Germany and duplicating our European model in Asia; in that way, we can get closer to our Asian customers.”
Lee Jenkins, senior product manager, Cytiva Diagnostic Services, told us today that the design lab in Tonglu can help with the major challenges a diagnostic company will face when developing a test.
Such challenges include the selection of the right components to put in the test.
The lab can also help with optimizing the performance of the test so it can meet the required sensitivity and specificity that regulators require, as well as consultation services to support scale up manufacturing of the test, from a bench-top test to a larger validation batch size.
“With this new lab we meet the needs for local diagnostics capabilities from our Asia customers. They no longer have to send samples to our other lab in Germany. We expect services to be in high demand and already have half a dozen projects in the pipeline,” added Jenkins.
The new China lab offers:
- Raw material research advice: Helping customers 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.