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Re-defining the limits of single batch assay stabilisation

In response to increasing demand for stabilised molecular diagnostic assays, we have significantly increased our single batch lyophilised reagent bead manufacturing throughput to 300,000 reactions per freeze drying run and are now progressing towards a capacity of 100 million tests per annum.

Single batch manufacturing of lyophilised beads

Biofortuna Limited

Utilising bespoke high precision automation, four dedicated freeze driers (each with 3.5m2 shelf capacity) housed in a 180m2 ISO-7, Class 10,000 clean room with humidity control at <2%RH, we are able to provide our customers with a range of lyo stable solutions including bulk reagent formulation, robotic liquid dispensing and a range of flexible packaging options and sub-assembly placement.

Our scalable manufacturing services support a range of clients from disruptive technology developers through to global point-of-care (POC) in vitro diagnostic (IVD) manufacturers. We work with complex formulations including next generation sequencing (NGS) reagents, micro-spheres, paramagnetic particles, latex and colloids including a wide range of bio-conjugation with enzymes, antibodies & molecular master mixes and probes”.

Lee Walker, Head of Technical Services.

Together with our on-site R&D team,  we offer a complimentary range of outsourced laboratory services that include genomicscustom development and ISO:13485 contract manufacturing services.

Source:

Biofortuna Limited

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