Avacta Group plc, the developer of Affimer biotherapeutics and reagents, has appointed BBI Solutions, part of BBI Group, to manufacture the saliva-based rapid SARS-CoV-2 antigen test that is being developed with Cytiva. 
 
BBI Solutions is a global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics market, with manufacturing sites in five different countries, spanning four continents. 
 
The manufacturing 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. 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,” commented Dr. Alastair Smith, chief executive of Avacta Group. “We anticipate very high demand for the COVID-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand. We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-CoV-2 antigen testing both now, and in the next few years.”
 
“As we set out in the use of proceeds at the recent fund raising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic Product Development Manager, and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins for the COVID-19 tests and future diagnostic tests in the pipeline,” Smith added. “The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.”
   
Dr. Mario Gualano, chief executive of BBI Group, added, “BBI is 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. 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.”