Supporting the Global effort to upscale COVID-19 testing

As an ISO 13485 certified and FDA registered facility we have been inundated with requests for assay development and manufacturing support to address the novel SARS-CoV-2 virus.

Over the last ten months we have risen to that challenge and worked with some of the worlds leading authorities in molecular testing to help them develop, modify and mass produce over 4 million tests per week.

Highlights to date include

Scale-up & manufacture of RUO COVID-19 PCR assay

Biofortuna were approached by a molecular diagnostics company in April 2020 with a prototype qPCR COVID-19 assay that they were looking to scale-up to manufacture.

A technical transfer of documentation and protocols was initiated and Biofortuna successfully replicated the customer process as part of a rapid feasibility project.

Initial pilot batches passed QC requirements and Biofortuna subsequently manufactured in excess of over 400,000 tests to be supplied to the customer based in the EU.

This formulation, dispensing and kitting process was completed within 1 week, on-time and on budget.

Rapid prototyping and regulated manufacture of 2 million CE-mark tests

QuantuMDx approached Biofortuna in April 2020 to be their manufacturing partner to assist with the development of a custom lyophilised RT-PCR SARS-CoV-2 assay.

Utilising Biofortuna’s extensive experience in lyophilisation, a proof-of-concept study was conducted to assess the performance of the mastermix and associated reagents.

A triple batch validation followed and Biofortuna was able to support QuantuMDx in achieving their CE-mark status.

The commercial launch delivered in excess of 2 million tests which were manufactured at Biofortuna.

Read the press release for more details

Tech-Transfer of customer mastermix to support over 10 million tests

UK based plc approached Biofortuna to increase manufacturing capacity for their critical lyophilised mastermix component, part of their gold standard CE-marked qPCR COVID-19 assay.

SOPs and Batch Manufacturing Records were transferred to Biofortuna under NDA and a pilot batch manufacture project undertaken to replicate the in-house material.

Triple Batch Validation followed and the material is now in weekly routine manufacture at Biofortuna.

Kitting & Assembly of Gold Standard COVID-19 Test

Novacyt Group engaged with Biofortuna to offer additional capacity to formulate, dispense and kit their COVID-19 assay. The project was initiated to support a UK government contract of 288,000 tests a week that was awarded to Novacyt in May 2020.

Read the press release for more details

Biofortuna’s Genomic Services division supporting COVID-19 Testing

As part of the UK government’s call for private UK based labs to support the national testing effort, Biofortuna is currently supporting the Volunteer Testing Network and running critical screening tests at its dual-site facility

Learn more about the Volunteer Testing Network

Find out how we can help you

Upscaling production

To meet this unprecedented demand we have up-scaled our own development and production operation and are now able to offer our experience and resource to more diagnostic test manufacturers than ever before, across a range of sectors.

To find out how we can help you, please click on the Contact us link below.

Do you have a project that we can help with? Contact us now to arrange an informal exploratory discussion.
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