- Ready-to-use lyophilized kit components simplify logistics and storage
- Easy-to-use protocol
- Different versions for conventional PCR, real-time PCR or digital PCR*
- Validated according to EP 2.6.7, JP G3, USP <63> and USP <1071>
- TaqMan® probes ensure the highest level of PCR specificity
- Detect > 100 mycoplasma species
- Lyophilized, non-infectious mycoplasma sensitivity standards, each containing 10 or 100 CFU of the chosen Mycoplasma species
Mycoplasma, being the smallest known self-replicating bacteria, are
capable of infecting a wide range of cell cultures used in the
production of biopharmaceuticals, thus posing a significant threat to
the safety and efficacy of biopharmaceutical products.
The implementation of robust mycoplasma testing protocols is
essential to ensure the safety and quality of biopharmaceutical
products. Early detection and mitigation of mycoplasma contamination can
prevent costly production delays, product recalls, and potential harm
to patients. Therefore, biopharmaceutical manufacturers must employ
validated mycoplasma testing methods as part of their quality control
procedures. PCR-based methods have become the preferred choice for
mycoplasma testing due to their high sensitivity, specificity, and rapid
time-to-result.
Minerva Biolabs has developed several mycoplasma detection kits that
are specially designed for institutions and companies involved in
testing mycoplasma contamination according to EP 2.6.7, USP <63>
and JP G3.
The kits enable rapid and reliable identification of mycoplasma in
cell culture and cell culture derived biologicals, like ATMPs. All
Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) species so far
described as contaminants of cell cultures and media components are
specifically detected by amplification of a highly conserved rRNA
operon, or more specifically, the 16S rRNA coding region in the
mycoplasma genome.
Explore our innovative, robust and highly sensitive mycoplasma
detection kits for conventional PCR, real-time PCR or digital PCR* that
has been effectively validated according to EP 2.6.7, USP <63> and
JP G3.
(* according products will be released soon. Subscribe to our newsletter to get notified.)
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