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Mycoplasma
is a common contaminant of mammalian cell
culture samples. Infection is persistent,
difficult to detect and diagnose, and very
difficult to cure. The concentration of
Mycoplasma in infected cultures can be as
high as 101 colony-forming units per mL, and
their presence can change many of the cell
reactions, including altering cell growth
rate, inducing morphological changes or cell
transformation, and mimicking virus
infection. Regulatory guidance requires that
all products derived from mammalian cell
culture be tested for the presence of
Mycoplasma. In a typical biopharmaceutical
manufacturing facility, tests for Mycoplasma
infection can be conducted on master and
working cell banks, during cell expansion
(from spinner flasks to bioreactors) and on
harvest media.
To
address this deficit, JRF have started Gene
Mycoplasma detection service using Real Time
PCR technology with the kit of Mycoplasma
detection assay which able to detect all 90
Mycoplasma species, not just the most common
species, including Mycoplasma, Acholeplasma
and Spiroplasma species and which follow the
guidance provided by European Pharmacopoeia
5.8, Sec. 2.6.7 on the validation
requirements for nucleic acid
amplification-based methods for detection of
Mycoplasma.
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