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Quality control: mycoplasma and residual testing

Improve your quality control strategy

As CustomBiotech is part of a global personalized healthcare organization that has both diagnostics and pharmaceutical enterprises, we know what is critical to your success.  Contamination and impurities can have a significant impact on a product's purity, safety and efficacy.  

Managing quality control is integral to your business and should enable rather than hinder progress. We strive to create and provide products and services that help you deliver enabling therapies and diagnostic tools.

Mycoplasma and impurities QC testing

CustomBiotech provides rapid and reliable quality control testing kits for mycoplasma, residual host cell DNA, and residual protein impurities. These solutions are key components for an optimal quality control strategy to safeguard the manufacture of your product(s). 


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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. 


MycoTOOL Mycoplasma Real-Time PCR Kit

Revolutionize your mycoplasma QC testing

MycoTOOL Mycoplasma Real-Time PCR Testing System Advantages

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


Direct testing of unprocessed cellular samples that detect intracellular mycoplasma 

Residual host cell DNA quantification

In the manufacturing of biologics using expression systems, host cell DNA levels should be low in the final product to meet regulatory guidelines appropriate for the product’s intended use. Manufacturers of biologics use different approaches to show low residual DNA in the purification process and final substance. Pilot experiments showing removal of added host cell DNA, lot-to-lot testing to show purity and reproducibility or an appropriately conducted clearance study for DNA removal are just some examples. The critical consideration regardless of your testing strategy is to use a sensitive residual host cell DNA kit that meets or exceeds the relevant regulatory requirements of your product.

Residual DNA E. coli kit and CHO kit

CustomBiotech detection solutions for residual host cell DNA are based on real-time quantitative PCR (qPCR) that provides highly sensitive quantitation of DNA levels from E. coli or CHO expression systems. Robust and easy to use, the kits can be employed at each step in the purification process and in drug substance samples to confirm purity within hours. Developed to meet WHO requirements, the kits offer exceptional sensitivity.

  • Highly sensitive quantification of host cell DNA that meets WHO requirements
  • Suitable for use across a broad range of sample types and at various stages of your process
  • Optimized sample preparation protocol for high DNA recovery
  • All-inclusive reagents kit

Regulatory disclaimers are listed on the respective product pages.

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