Avacta Group, Wetherby, UK, the developer of Affimer biotherapeutics and reagents, has appointed BBI Solutions, Crumlin, UK, to manufacture the saliva-based rapid SARS-CoV-2 antigen test that is being developed with Cytiva, Marlborough, Mass. The agreement between Avacta and BBI comprises the accelerated development and validation of a scaled-up manufacturing process that has the potential to ramp up to a production capacity of millions of tests per month. Avacta, Cytiva, and BBI are in the process of the technology transfer of the prototype and related manufacturing procedures for the saliva-based rapid SARS-CoV-2 antigen test from Cytiva to BBI.
Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK government’s CONDOR program and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product. “I am delighted to be working with BBI to manufacture the rapid covid-19 test,” says Alastair Smith, BSc, PhD, chief executive of Avacta Group. “BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get the product to market as quickly as possible.” “BBI are delighted to have been appointed to lead the manufacture of Avacta’s rapid coronavirus antigen test, and to be able to further extend our lateral flow expertise to addressing the global challenges presented by covid-19,” says Mario Gualano, PhD, chief executive officer of BBI Group. “Our ability to respond rapidly to Avacta’s needs is testament to our team’s diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility.” For more information, visit Avacta and BBI Solutions.