Life sciences business, Avacta Group, has been appointed BBI Solutions to manufacture the saliva-based rapid SARS-CoV-2 antigen test that is being developed with Cytiva.
BBI Solutions – part of the BBI Group – 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 Wetherby and Cambridge-based 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.
AIM-lised 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 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.
“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,” said Avacta Chief Executive Dr Alastair Smith.
“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.”
He added: “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.”