24
Jun

Rapid prototyping and regulated manufacture of 2 million CE-mark Covid-19 tests

We were approached by a major UK headquartered diagnostic developer in April 2020 looking for assistance with the development of a custom lyophilised RT-PCR SARS-CoV-2 assay. Listing Our extensive lyophilisation expertise, we were able to provide a comprehensive  proof-of-concept study  to assess the performance of the mastermix and associated reagents. A triple batch validation followed and we were able to

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20
Mar

Lyophilisation of Point of Care (POC) IVD qPCR assay and controls

Biofortuna are currently manufacturing assays and controls for a UK based molecular diagnostics company, producing a POC IVD device for the diagnosis of infectious diseases. Biofortuna were required to: Develop a custom lyophilisation process for a qPCR based assay for the detection of infectious diseases. Develop a custom lyophilisation process for multiple control samples. Perform a comprehensive technology transfer of
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20
Mar

Contract immunoassay development for early cancer detection

Biofortuna have signed a long-term contract to provide contract research and development to a leading early cancer detection company. This relationship will lead to the commercialisation of an ELISA based oncology assay. Biofortuna will be providing: Design and development consultancy of immunoassay technologies. Expertise in ELISA reaction stabilisation methods. Full validation and verification testing. Technology transfer of small scale manufacturing
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20
Mar

Dispensing and kitting of Next Generation DNA Sequencing

A Next-Generation Sequencing company was looking for a partner to outsource the dispensing and kitting of their CE-marked kit. Biofortuna were required to: Transfer a dispensing procedure for a complex NGS kit to its manufacturing facility. Complete an extensive validation plan that included; dispense volumes, plate seal, adverse transport and packaging studies. Provide a stable partner with a robust manufacturing
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20
Mar

Lyophilisation of LAMP-based diagnostic kit

A diagnostics company looking for a contract services provider have used Biofortuna to launch their first CE marked, lyophilised LAMP based kit onto the market. This kit will be used for the direct detection of meningococcus and significantly reduces set up times from current preferred methodologies. The client was specifically looking for a contract provider to: Develop a lyophilisation process
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20
Mar

Assay development of qPCR tests

Biofortuna have recently completed the design and development of a set of 384 multiplex genotyping Taqman-based PCR reactions. Biofortuna performed the following: Design of amplification primers and hydrolysis probes. Kit component configuration testing. Assay optimisation. Sourcing suitable templates to enable validation of reactions. Validation and verification studies. Generation of complete design history file. Transfer of designs to customer for manufacture.
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20
Mar

Assay development of a qPCR master mix

Biofortuna have recently provided a bespoke qPCR master mix to be used with hydrolysis probes as part of a complex genotyping kit. The master mix was designed under Biofortuna’s ISO:13485 and FDA quality system. The master mix will be used as part of an IVD kit which has undergone a global launch. Biofortuna provided the following: Design of buffering components.
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