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Quality control: mycoplasma and residual testing

Optimize your bioprocess quality control: reliable testing for purity, safety, and efficacy

Ensuring product purity, safety, and efficacy is paramount. Contamination and impurities pose a significant risk at every stage of development and manufacturing. Your quality control (QC) strategy must be robust and efficient, enabling progress rather than hindering it.

As part of Roche, a global organization with unique expertise spanning both pharmaceuticals and diagnostics, CustomBiotech intimately understands this critical balance. We provide reliable, innovative QC solutions designed to safeguard your process and help you confidently deliver transformative therapies and diagnostic tools.

Mycoplasma and impurities quality control 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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Rapid mycoplasma detection for biomanufacturing

Mycoplasma contamination poses a significant risk during the production of biopharmaceuticals, vaccines, and cell-based therapeutics. Ensuring product safety and integrity is paramount. Consequently, regulatory agencies mandate rigorous testing to confirm the absence of mycoplasmas before products can be released.

The MycoTOOL Mycoplasma Real-Time PCR Kit provides an optimized solution for mycoplasma testing at every stage of your manufacturing process, from raw material screening to final lot release.

Quality testing with the MycoTOOL kit offers robust, specific, and sensitive detection, delivering definitive results in less than 5 hours. This single, standardized assay can be implemented at various in-process control points and for final lot release. Using one system ensures consistent sensitivity criteria are applied throughout your entire manufacturing workflow. The rapid results provide an essential early warning system, helping to minimize the potential impact of a contamination event. Furthermore, the assay is an accepted replacement for traditional, time-consuming culture methods, reducing testing timelines from weeks to mere hours.

MycoTOOL Mycoplasma Real-Time PCR Kit

Revolutionize your mycoplasma QC testing

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MycoTOOL Mycoplasma Real-Time PCR Testing System Advantages

Broad detection of more than 150 mycoplasma species
Demonstrated sensitivity to less than 10 CFU/ mL for common mycoplasma species
Proven specificity avoids crossreactivity with closely related bacterial species

Multiple efficient sample preparation options that fit throughput needs
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