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Validation

Validation Services

Mycoplasma Biosafety offers high-quality validation and spiking services to detection kit manufacturers, to kit end users, and to peptone and serum producers:

  • Method and product-specific validation of NAT-based and other rapid mycoplasma detection assays
  • Product-specific mycoplasma growth kinetics analysis for risk mitigation
  • Process validations for mycoplasma removal

 

Method and Product-specific Validation of Rapid Mycoplasma Detection Methods

Alternative faster mycoplasma detection methods exploiting molecular or enzymatic activity-based techniques can be used for regulatory mycoplasma testing, if they fulfil the requirements and expectations of the regulatory authorities and if their specificity, sensitivity (limit of detection, LOD) and robustness are comparable to the conventional culture methods.

Mycoplasma Biosafety is a competent partner to carry out method or product-specific validation and comparability studies in compliance with regulatory requirements, and also offers spiking services to support clients in performing their own in-house validation studies.

Culture and indicator cell culture procedures at present are still the current industry standard for regulatory mycoplasma testing. However, they are not entirely satisfactory in an industrial setting. The main drawback is that both tests are labor-intensive and time-consuming.  Mycoplasma detection assays exploiting NAT- or enzymatic activity-based test methods can satisfy the strong demand for fast and efficient alternatives. Any such alternative method must be validated individually to prove the ability to reliably detect low-level mycoplasma contamination in a specific product and to demonstrate at least the same performance quality as conventional culture methods in order to get approval from the regulatory authorities to use this method for regulatory mycoplasma testing of that particular product. Mycoplasma Biosafety is expert for these regulatory compliant validation and comparability studies, for kit manufacturers, as well as for kit users.

 

Mycoplasma Biosafety is particularly specialized in conducting product-specific PCR test validation studies in compliance with EMA, FDA or Japanese PMDA requirements

We offer:

  • Feasibility studies
  • Prevalidation studies
  • Validation studies
  • Comparability studies
  • Spiking services
  • Consultancy services

Please contact us if you need any information about the different mycoplasma PCR detection kits which are commercially available. We have particular experience with performance validation of the MycoSEQ Mycoplasma Real-Time PCR Detection Kit (Thermo Fisher Scientific/Life Technologies), and the MycoTOOL Mycoplasma Real-Time PCR Kit (Roche), but we also offer to carry out product-specific performance validation studies based on other commercial PCR detection systems, such as the MycoFinder kit (Nissui Pharmaceutical) for the Japanese market, or based on "home-brew" PCR assays developed by the client.

 

Product-specific Mycoplasma Growth Kinetics Analysis for Risk Mitigation

We offer to carry out mycoplasma growth kinetics studies in different product matrices to investigate the growth characteristics of particular mycoplasma test strains under production process conditions. Such studies are valuable tools to evaluate the performance of rapid PCR-based mycoplasma testing methods at various stages of the production process in case of a low-grade mycoplasma contamination. Such an evaluation reduces the risk of potential detection failures under real conditions and ensures the reliability of a mycoplasma testing method what is ultimately linked to product safety.

For further information, please contact us: office@mycoplasma.cc

 

Process Validations for Mycoplasma Removal

We offer to carry out the following process validations:

  • UV irradiation
  • Mycoplasma retention validation of membrane filters
  • Performance evaluation of mycoplasma elimination reagents

Please contact us: office@mycoplasma.cc  for detailed information.

 

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