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BioOutsource Mycoplasma Testing

BioOutsource Mycoplasma Testing

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Published by Axiaer Solutions

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Categories:Types, Research, Science
Published by: Axiaer Solutions on Sep 02, 2011
Copyright:Attribution Non-commercial

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09/02/2011

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Testing for Mycoplasma species usingPolymerase Chain Reaction Techniques
All regulatory guidelines speciy that products manuactured using cells must be testedor the presence o Mycoplasma species. This includes all biologics and some vaccines.The testing is prescribed or master and working cell banks, virus seed lot and bulkharvests. Traditionally the tests or Mycoplasma have included cell culture or growth onmedia (broth and agar) however nucleic acid amplifcation techniques (NAT) may beused as an alternative to one or both o the other methods ater suitable validation bycertain guidelines. The reason or the acceptance o the NAT techniques by the EuropeanPharmacopoeia (EP) is that they have recognised that some samples are difcult to test orMycoplasma either due to cytotoxicity or due to the rapid turnaround o samples requiredor particular products.
Polymerase Chain Reaction
SECTION
2.6.21 o the European Pharmacopoeia statesthat Nucleic acid amplifcation, such as PCR, techniques
may be used or detection o mycoplasmas. NAT indicatethe presence o a particular nucleic acid sequence andnot necessarily the presence o viable mycoplasma. Thispresents some advantages and disadvantages; theprincipal advantage is the sensitivity and specifcity othese assays. The main disadvantage is the detection onon viable Mycoplasma sequences and these sequencesmay be present in many o the reagents and culturematerial used in the production process. This is because,whilst the manuacturing o the reagents will haveeliminated the viable organisms, some DNA will remaindue to it being very difcult to remove. A number odierent techniques are available which can be appliedto detect this presence and the EP does not speciy aparticular method but does outline the validation whichis expected. The EP also indicates that commercial PCRdetection kits will be suitable or use or release assaysand specifes that certain elements o the validation maybe carried out by the manuacturer to acilitate use othe assay commercially. The PCR technique may be usedinstead o the culture method and the indicator cell culturemethod ater suitable validation as a release test, thussaving time and cost.
BioOutsource Service Offering
BioOutsource is pleased to oer the Applied BiosystemsPrepSEQ
 
Mycoplasma
detection kit or use in detectingMycoplasma to EP requirements. The PrepSEQ kit was

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