Many regulatory guidelines state that cell banks and cultures used in the production of biologics must be tested for mycoplasma. Mycoplasma infections can cause severe problems in manufacturing as these organisms can alter DNA, RNA and modify host cell plasma membrane antigens. As such, mycoplasma can affect the very product being synthesized and lead to a major deviation for a company – halting the recombinant production for months and requiring extensive decontamination processes.
If you are thinking of making the switch, download this whitepaper to learn about:
- Octapharma's evaluation of the PCR method
- The process of laboratory set-up including instrument qualifications and software requirements
- Method development, validation and ensuring assay sensitivity which meet regulatory requirements