Design and Development of a qPCR Mastermix

Biofortuna have recently provided a bespoke qPCR mastermix to be used with hydrolysis probes as part of a complex genotyping kit. The mastermix was designed under Biofortuna’s ISO:13485 and FDA quality system. The mastermix will be a 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