Avacta appoints BBI Options as manufacturing companion for the speedy SARS-CoV-2 antigen check being developed with Cytiva
Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is happy to announce that it has appointed BBI Options, a part of BBI Group (“BBI”), to fabricate the saliva-based speedy SARS-CoV-2 antigen check that’s being developed with Cytiva.
BBI Options is a number one international developer and producer of uncooked supplies and completed check merchandise for the in-vitro diagnostics market, with manufacturing websites in 5 completely different nations, spanning 4 continents.
The manufacturing settlement between Avacta and BBI contains the accelerated growth and validation of a scaled-up manufacturing course of that has the potential to ramp as much as a manufacturing capability of hundreds of thousands of assessments per thirty days. Avacta, Cytiva and BBI are within the means of the know-how switch of the prototype and associated manufacturing procedures for the saliva-based speedy SARS-CoV-2 antigen check from Cytiva to BBI.
Avacta goals to start medical validation of the check as quickly as doable through the use of the primary pilot batches generated as a part of the know-how switch course of for these research. In parallel with these medical validation research, which shall be run inside the UK authorities’s CONDOR programme and probably with different collaborators globally, BBI will work with Avacta and Cytiva to supply the extra technical documentation that’s required for CE marking of the ultimate product.
Dr. Alastair Smith, Chief Govt of Avacta Group, commented: “I’m delighted to be working with BBI to fabricate the speedy COVID-19 check. BBI has been glorious to work with to outline a extremely compressed product growth timeline that can enable us to get the product to market as rapidly as doable.
We anticipate very excessive demand for the COVID-19 speedy check and shall be working with our most well-liked manufacturing companions at BBI to fulfill that demand. We’re actively persevering with our discussions with different manufacturing companions to make sure that we have now entry to further manufacturing capability to deal with the worldwide want for SARS-CoV-2 antigen testing each now, and within the subsequent few years.
As we set out in using proceeds on the latest fund elevating, we have now now expanded our product growth group with the appointment of an skilled in-vitro diagnostic Product Improvement Supervisor, and we’re increasing the protein manufacturing amenities with a view to meet the anticipated demand for Affimer proteins for the COVID-19 assessments and future diagnostic assessments within the pipeline.
The diagnostics enterprise has additionally been working at a speedy tempo in direction of ISO13485 accreditation, which can streamline CE marking and different regulatory approval processes.
I’m immensely happy with what has been achieved by Avacta’s diagnostics group. Their progress in just some months would have been difficult underneath regular circumstances, however with the extra restrictions imposed by COVID-19, it has been an excellent instance of exhausting work, ingenuity and dedication from a world-class group.
I stay up for additional updating the market as we undergo the following phases of producing scale-up, medical validation, regulatory approval and product launch.”
Dr. Mario Gualano, Chief Govt of BBI Group, stated: “BBI are delighted to have been appointed to guide the manufacture of Avacta’s speedy coronavirus antigen check, and to have the ability to additional lengthen our lateral move experience to addressing the worldwide challenges offered by COVID-19.
Our skill to reply quickly to Avacta’s wants is testomony to our group’s diagnostic experience and the supporting manufacturing and high quality techniques we have now carried out at our ISO13485 accredited facility.”
This announcement incorporates data which, previous to its disclosure, was thought-about inside data for the needs of Article 7 of Regulation (EU) No 596/2014 (MAR).
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