On BBI webite7 Aug 2020 01:24
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BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer
08/06/2020
BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer
BBI Solutions is pleased to announce it 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 plc (AIM: AVCT) in conjunction with Cytiva.
South Wales based BBI Solutions is a leading 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.
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 announced today 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 commented: “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 rec