INTRODUCTION

Mycoplasmas represent cell wall-lacking bacteria that are the smallest self-replicating prokaryotic organisms. This chapter describes the validation and testing application of qualitative nucleic acid amplification techniques (NATs) for the detection of mycoplasma contamination in biotechnological products and cell-based materials. The genus Mycoplasma belongs to the class Mollicutes. The term “mycoplasma” is often used generically, as it is in this chapter, to refer broadly to members of the Mollicute class, including Mycoplasma, Mycoplasmoides, Mesomycoplasma, Metamycoplasma, Mycoplasmopsis, Ureaplasma, Acholeplasma, and Spiroplasma, among others. Importantly, the nomenclature of mycoplasma and any other bacterial taxa is subject to change due to ongoing taxonomic research.