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Mycoplasma detection kits

Mycoplasma-free results in hours 

 

Whether you supply raw materials or manufacture biopharmaceuticals, vaccines, or cell-based therapeutics mycoplasma is a contamination that poses risk to patients.  Therefore, regulatory agencies require manufacturers to test their products and ensure the absence of mycoplasmas for release.
 

The MycoTOOL Mycoplasma Real-Time PCR kit is an optimal mycoplasma testing system for every step in your process, including lot release.
 

Quality testing with the MycoTOOL Mycoplasma Real-Time PCR kit is robust, specific and sensitive and delivers results in less than 5 hours. Therefore, the kit can be used as a single test system at various in-process points and for lot release. This way, the same sensitivity criteria are used throughout your manufacturing process. As an early warning system, the fast results minimize the impact of possible contaminations.  The assay is also an acceptable replacement for traditional culture methods used for release testing, cutting weeks of work to just hours. 


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Mycoplasma

Evaluation of three DNA purification methods

DNA preparation for the MycoTOOL Mycoplasma Real-Time PCR Kit detection of regulatory recommended mycoplasma species

Advantages of the MycoTOOL Mycoplasma Real-Time PCR Testing System

 

 

 

icon broadest detection

Broad detection of more than 150 mycoplasma species

icon sensitivity

Demonstrated sensitivity to less than 10 CFU/ mL for common mycoplasma species

icon specificity

Proven specificity avoids crossreactivity with closely related bacterial species

icon efficient sample preparation

Multiple efficient sample preparation options that fit throughput needs

icon validation

Validated according to E.P. 2.6.7 NAT validation guidelines

image

Direct testing of unprocessed cellular samples that detect intracellular mycoplasma 

MycoTOOL Mycoplasma Real-Time PCR Kit is for for use in quality control/manufacturing process only. 
All regulatory disclaimers are listed on the respective product pages.

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