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