BBI Solutions OEM Limited

Original article published on 10/10/2020

Iceni Diagnostics has appointed BBI Solutions to generate clinical trial batches for their new, rapid SARS-COV-2/Influenza virus detection test. The test exploits the diagnostic company’s unique, proprietary HPGR™ (Host-Pathogen Glycan Recognition)  technology to detect the presence of live virus in non-invasive samples within 15 minutes.

The agreement between Iceni Diagnostics and BBI will transfer protocols to standard lateral flow equipment. This work will enable the generation of devices for clinical trials, with the expectation of moving to assay scale-up and manufacturing transfer.

BBI is an ISO 13485 accredited manufacturer and will work with Iceni Diagnostics to deliver the necessary information required for CE marking of the final product. In parallel, similar studies will be undertaken in the US through a comparable program with a US manufacturer.

Professor Rob Field (pictured), CEO of Iceni Diagnostics said: “We are delighted to be working with BBI on our rapid SARS-COV-2/Influenza diagnostic. BBI has a clear understanding of our unique HPGR™ technology, and we are confident they can help us meet our ambitious targets to get product to market as quickly as possible.

“We are excited about the potential of this test.  Our proprietary technology identifies intact virus, unlike most existing tests that identify viral genetic material.  This crucial difference means that a positive result is a key indicator that live, active virus is present, giving a clear signal of current infection, whether the patient has started to show symptoms or not. Significantly, the test may also identify asymptomatic carriers and thus limit virus spread. It will similarly give rapid clearance to those who need to return home or to their school or workplace but who may still be carrying inactive virus particles following infection.

“We are manufacturing a duplex test that differentiates between SARS-COV-2 and Influenza from one sample.  Covid-19 and human flu have similar symptoms so our test will be vital in supporting lockdown decisions during the winter flu season.

“The test is housed in a lateral flow device, with results available within 15 minutes. This makes it ideal to use as a rapid triage option to complement laboratory testing. 

“Much interest is being generated worldwide and Iceni Diagnostics is heavily involved in generating the required investment to rapidly accelerate validation, manufacture and distribution to the global market.”

Dr. Mario Gualano, Chief Executive of BBI Group, said “BBI is delighted to extend our lateral flow development expertise to assist Iceni in translating their HPGR™ technology to market readiness for SARS-Cov2 and Influenza testing.

With BBI’s extensive experience in the In Vitro Diagnostics arena, we are confident that the Iceni Diagnostics technology offers significant potential benefits in pathogen detection while maintaining compatibility with an established, scalable and trusted lateral flow diagnostic platform.

We look forward to working together in further addressing the global challenges presented by COVID-19.”

Successful independent evaluation from PHE for COVID-19 lateral flow antibody test

CRUMLIN-BASED BBI Solutions, a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market, notes the press release issued by the UK Rapid Test Consortium (“UK-RTC”), of which BBI Solutions is a partner, on the UK Government’s first order for one million COVID-19 lateral flow antibody tests (the “AbC-19™ Rapid test”).

This first order is part of the UK Government’s plans to roll-out COVID-19 surveillance studies to help build a picture of how the virus has spread across the country.

The AbC-19™ Rapid test uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need for a patient sample to be sent to a laboratory.

The test is currently CE-Marked for professional use, and can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. The UK-RTC are seeking approval from the MHRA for self-test use.

The consortium will draw on BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

BBI Solutions is also working closely with healthcare providers to optimise its smartphone diagnostic reader to be used in conjunction with the test. BBI’s patented Novarum technology will guide users at home through performing a test before securely providing the results with their healthcare provider.

The UK-RTC is reproduced in full at the end of this statement.

Dr Mario Gualano, CEO, BBI Solutions, said: “I am delighted that the UK-RTC has now received its first contract from the UK Government for our COVID-19 lateral flow antibody test.

“We believe that the AbC-19™ Rapid test has the immediate opportunity to allow the UK to build a swift and clear picture of how the virus has spread throughout the population. It also has the potential to be deployed in conjunction with vaccine candidates to help assess initial immune responses.”

 
Press Release from the UK-RTC (issued on 6 October 2020):

UK-RTC AbC-19TM Rapid Test receives successful independent PHE evaluation

The UK Government has entered into a contract with Abingdon Health, on behalf of the UK-Rapid Test Consortium (“UK-RTC”), for the supply of the AbC-19TM Rapid Antibody tests. As part of the contract the UK Government has placed its first order for one million COVID-19 rapid antibody tests.

This follows an independent evaluation commissioned by the UK government of the AbC-19TM Rapid Antibody test, which will be published in full in due course by PHE, after peer review.   

The “AbC-19TM Rapid Test”, uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to go to a specialised laboratory. 

The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care.  It has already received the “CE mark”, which indicates health and safety conformity for goods sold in the UK and EU.     

The test will make it possible to build a swift and clear picture of how the virus has spread throughout the UK population. 

It will also be able to help establish the effectiveness of any vaccine which provides protection by creating new antibodies.  This information will be critical to managing current and future outbreaks of COVID-19.

Mass production is already under way. The antibody test will be rolled out under the government’s COVID-19 surveillance studies to help build a picture of how the virus has spread across the country. Surveillance studies are vital to develop our understanding of how antibodies work.

The UK Government helped to set up the UK Rapid Test Consortium and invested in the development of the tests.

Health Minister Lord Bethell said: “This home antibody test developed by our outstanding British scientists and researchers at the UK Rapid Test Consortium will provide critical insight into how the infection has spread, growing our understanding of coronavirus so that we can better respond to it.”

The test detects IgG antibodies to “full trimeric spike proteins” of the SARS-CoV-2 virus.  This means the test detects those antibodies which interfere with the virus’s ability to enter the human cells.

An extensive validation study performed by Ulster University involving over 1000 participant blood samples is currently under peer review for publication.

About the UK-RTC

The UK-Rapid Test Consortium was set up by Abingdon Health to bring together scientists and medical technology manufacturers to be able to deliver millions of test kits as quickly as possible.  By working together, some of the UK’s leading medical technology companies will deliver more volume more quickly to help fight Covid-19.

The UK Government supported the setup of the UK Rapid Testing Consortium and invested in the development of the rapid antibody tests.

The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics, BBI Solutions and CIGA Healthcare.

BBI Solutions is recruiting for roles to support its work as part of a UK Government consortium, tasked with developing and manufacturing a Covid-19 Point of Care antibody test to support the government strategy on COVID-19 testing.

Four months ago, UK Government established the UK-Rapid Test Consortium (UK-RTC), in which BBI Solutions is a partner, to develop a COVID-19 lateral flow antibody test that can be used by people in their homes to determine if they have an antibody response to COVID-19, which would confirm previous infection.

This test together with the Government’s overall strategy on testing and vaccination mark a move towards detecting and eradicating the virus.

The successful completion of the development of the assay means BBI and its UK-Rapid Test Consortium (UK-RTC) partners require more staff to meet production demands in advance of final approval of the test by regulatory authorities.

BBI is investing in multiple roles at its manufacturing headquarters in Crumlin, South Wales, and these roles will be based in Manufacturing, Quality Control, Compliance, Technical Operations and Supply Chain.

Given the scale of the potential demand for the test within the UK, the Consortium will introduce a phased ramping up in capacity, but is making these key appointments in preparation for ensuring a smooth transition to high volume production at the manufacturing facilities by the end of the year.  

This is a unique opportunity to join a progressive and growing organisation, which is contributing to South Wales and the UK’s resistance to the pandemic.

BBI Group Chief Executive Dr Mario Gualano said: “Given the difficult times we find ourselves in, we are delighted to announce vacancies. We have always valued our employees and they have been key to the speed at which our work with UK-RTC has progressed. We are pleased to be able to build on our team – these are exciting times for BBI and we envisage these key appointments playing their part in further developments with the Consortium.

“This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme.

“But we remain on track to deliver a test to the UK that will make a significant difference to the approach needed to manage COVID-19 infections.

“We are proud to be an integral part of this project and are thrilled with the progress to date.”

For further details on vacancies, please see https://www.the-bbigroup.com/careers/our-vacancies/

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 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.

“I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch.”

 This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).
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 BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer

BBI Solutions has welcomed the UK-Rapid Test Consortium’s (UK-RTC) announcement that their COVID-19 lateral flow antibody test, designed for people to use within their own homes, has received approval to go to market for professional use.

The AbC-19TM Rapid Test has been recognised with a CE mark for professional use, after meeting the technical performance for a rapid test as stipulated by the MHRA (The Medicines and Healthcare Products Regulatory Agency.) This means that the test is now available for commercial distribution for use by professionals.

Dr Mario Gualano, Chief Executive of BBI Group, said: “We are incredibly pleased that the AbC-19™ Rapid test has achieved CE mark for professional use, following the high specificity and sensitivity attained in trial results.

“We remain on track to deliver a test to the UK population that will make a significant difference to the approach needed to manage COVID-19 infections.

“The achievement represents another key milestone for the UK-Rapid Test Consortium, and we are proud to be an integral part of this vital project.”

Three production scale batches of the product have undergone validation and verification, with the devices showing sensitivity of 98.03% (95% confidence interval 95.03% to 99.46%) to test performance and specificity of 99.56% (95% confidence interval 98.40% to 99.95%).

These figures have been calculated following analysis of a total of 450 samples taken from individuals pre-September 2019 (negatives) and 203 patients who had symptoms of COVID19, or tested positive for COVID-19, and tested positive by a commercially available Antibody ELISA test (EuroImmunTM). Results are from analyses performed at the Ulster University and Abingdon Health laboratories.

If the population is assumed to have a 10% incidence of COVID19, the AbC-19TM Rapid test shows a 99.40% accuracy and is ready for high volume manufacture by the UK-RTC.

As part of its role within the Consortium, Crumlin-based BBI Solutions’ patented smartphone based reader technology will guide users at home through performing a test before securely sharing the results directly with the NHS.

The process will help ensure that people who have never performed a test like this before get the right result and feel confident in understanding it, while making sure that the NHS receives all data from each test to help plan and manage the disease’s progression.

Following the CE mark accreditation, the next steps for the test include further independent evaluation and to seek performance study approval from the MHRA to facilitate the self-test usability studies to be performed with Ulster University, using around 2000 volunteers. The conclusion of this study will allow UK-RTC to seek allowance (derogation) for self-testing via the MHRA, which is expected in the coming months.

This complex project has been completed in a very short time period compared to a normal test development programme. The UK-RTC, of which BBI Solutions is a member, has been committed to delivering this vital test to the UK public, to assist in the management of COVID-19 infections and aid further understanding of the disease. The Consortium is now ready to provide this test.

 


 

For further information, contact Lydia Lambert, Effective Communication via llambert@effcom.co.uk and 07890 953402  

Notes to editor:

Companies interested in distribution should register their interest at sales@uk-rtc.com
The “UK Rapid Test Consortium” (UK-RTC) comprises Oxford University, BBI Solutions, Abingdon Health, Omega Diagnostics and CIGA Healthcare.
The UK-RTC is utilising BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

Original article published on 23/04/2020

BBI Solutions is committed to enabling IVD companies worldwide to source critical reagents for the development of immunoassays.

In the midst of the Global Coronavirus Pandemic, BBI has partnered with The Native Antigen Company to deliver virus-specific antigens. These Coronavirus reagents are added to our complementary product portfolio, which includes enzymes, gold nanoparticles and secondary antibodies. This enhanced offering means that BBI can be your single source in the development of immunological Coronavirus diagnostic kits. BBI will have distribution rights to provide these products in China and will provide further antigen products as they are made available by NAC.

With immediate effect, BBI Solutions, is offering recombinant SARS-CoV Spike 1 and Spike 2 glycoproteins, and nucleoprotein for the 2019 Novel Coronavirus (SARS-CoV-2, Covid-19), and spike 1 glycoprotein for the related SARS-Coronavirus. The antigens are produced in Native Antigen Company’s proprietary expression systems, including their VirtuE (HEK293) expression system to ensure glycosylation and proper folding. All reagents are suitable to support vaccine R&D, diagnostic development, or basic research. 

The COVID-19 antigens and specific antibodies are critical tools for the development of rapid immunological testing kits alongside ancillary reagents and raw materials essential for the method development including secondary antibodies, enzymes and gold nanoparticles that enable Lateral flow-based methods.

Original article published on 23/04/2020

BBI’s global sales and supply chain capabilities will ensure secure distribution of these critical products worldwide, with a particular focus on supply to the Chinese market.

Dr Mario Gualano, BBI Group CEO, said “At this exceptional time when numerous countries are managing additional demands on their health systems, BBI is committed to ensuring products and services are rapidly and effectively available to diagnostic test manufacturers globally. We are delighted to work closely with The Native Antigen Company, to bring their critical immunoassay products to as wide a customer base as possible.”