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.
Analysis of enzyme options within mix.
Validation of mastermix as part of complete kit.
Generation of complete design history file.
Design and execution of incoming, in-process and end product quality control tests.
Transfer of development processes to full scale bulk manufacture.