Mycoplasma In-Process and Lot Release Testing: To PCR or Not to PCR

Mycoplasma are the simplest self-replicating prokaryotes, and they are frequent contaminants of cell cultures. Mycoplasma infection can affect nearly every cell culture parameter and result in decreased quantity or quality of product, inconsistency of manufacture, or possible adverse effects in recipients. Because of this, detection of mycoplasma is extremely important; but because of their small size, limited turbidity produced in culture, the wide diversity of mycoplasma species, and other factors, detection of mycoplasma can be challenging.

Some common culture methods of mycoplasma detection for cell bank and raw material release, in-process, and lot release testing have a long turnaround time (minimum 28 days). For most biological products, the mycoplasma culture test is the rate-limiting step for lot release. This white paper examines alternate methods of mycoplasma detection with shorter turnaround times, such as polymerase-chain-reaction (PCR)—based assays.