COVID-19

Biofortuna closely monitors the COVID-19 situation on a global basis to maintain the stability of both our and our customers’ supply chains.

We remain 100% guided by the advice of the UK Government and public health bodies on the appropriate ways of working.

A risk assessment and COVID-19 policy is in place to minimise any risk to our staff.

As an ISO 13485 accredited and FDA registered facility we have been inundated with requests for services, reagents and manufacturing support to address the novel SARS-CoV-2 virus.

Over the last two months the Company has responded positively and rapidly to the surge in demand, increasing the number of staff in our manufacturing facility by 400% and increasing output capability to more than 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

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