Avacta Group (AIM:AVCT) has appointed BBI Solutions, part of BBI Group (“BBI”), to manufacture its saliva-based SARS-CoV-2 antigen test that is being developed in conjunction with Cytiva.
The agreement between Avacta, the Affimer® developer, and BBI comprises of 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 the rapid tests per month.
Currently, Avacta, Cytiva and BBI are in the process of the technology transfer of the prototype and related manufacturing procedures for the antigen test from Cytiva to BBI.
Avacta said it is planning to use the first pilot batches generated as part of the technology transfer to begin clinical validation of the test.
Clinical validation studies will be run within the UK government’s CONDOR programme and potentially with other collaborators globally, while BBI will work alongside Avacta and Cytiva to produce additional technical documentation required for CE marking of the final product.
Shares in Avacta Group have skyrocketed over 400% since March and were trading 0.78% higher at 129.50p following this morning’s announcement.
“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,” said Dr. Alastair Smith, CEO of Avacta Group.
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.”
As part of a recent fundraising, the group has expanded its product development team by appointing an experienced in-vitro diagnostic Product Development Manager.
Avacta now plans to expand the protein production facilities to meet the expected demand for Affimer proteins for the COVID-19 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.
Smith added, “Their progress in just a few months would have been challenging under normal circumstances, 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.”
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