Testing for Mycoplasma species using
Polymerase Chain Reaction Techniques
All regulatory guidelines specify that products manufactured using cells must be tested
for the presence of Mycoplasma species.
This includes all biologics and some vaccines.
The...
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Testing for Mycoplasma species using
Polymerase Chain Reaction Techniques
All regulatory guidelines specify that products manufactured using cells must be tested
for the presence of Mycoplasma species.
This includes all biologics and some vaccines.
The testing is prescribed for master and working cell banks, virus seed lot and bulk
harvests.
Traditionally the tests for Mycoplasma have included cell culture or growth on
media (broth and agar) however nucleic acid amplification techniques (NAT) may be
used as an alternative to one or both of the other methods after suitable validation by
certain guidelines.
The reason for the acceptance of the NAT techniques by the European
Pharmacopoeia (EP) is that they have recognised that some samples are difficult to test for
Mycoplasma either due to cytotoxicity or due to the rapid turnaround of samples required
for particular products.
Polymerase Chain Reaction
SECTION 2.
6.
21 of the European Pharmacopoeia states
that Nucleic acid amplificat
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