BBI Solutions has been appointed to manufacture the saliva-based rapid SARS-COV-2 antigen test that is being developed by Affimer biotherapeutics and reagents developer Avacta Group in conjunction with Cytiva.
South Wales based BBI develops and manufactures raw materials and finished test products for the in-vitro diagnostics market with manufacturing sites in five different countries, spanning four continents.
Dr. Mario Gualano, chief executive of BBI Group, said: “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.
“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.”
The manufacturing agreement between BBI and Avacta comprises 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 technology transfer of the prototype and related manufacturing procedures for the saliva-based rapid COVID-19 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 programme 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.
Dr. Alastair Smith, chief executive of Avacta Group said: “I am delighted to be working with BBI to manufacture the rapid coronavirus antigen test. BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get product to market as quickly as possible.
“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 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 the coronavirus tests and future diagnostic tests in the pipeline.
“The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.
“I am immensely proud of what has been achieved by Avacta’s diagnostics team. It would have been challenging under normal circumstances to have made such progress in just a few months, but with the additional restrictions imposed by COVID-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.”
