Mycoplasma Testing Implementation and Validation

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Designed for purpose. Confirmed in validation. Accepted by regulatory agencies.

Per regulatory guidelines, therapies manufactured using cell culture must be proven free of Mycoplasma­ contamination. To be compliant, manufacturers have traditionally outsourced testing to labs that specialize in the 28-day culture-based test method. However, for short-shelf-life therapeutics such as cell therapy or other ATMPs, waiting 28 days for test results just isn't feasible. Projects for longer shelf-life therapeutics like antibody-based products may also benefit from rapid testing since faster results can help mitigate production risk or expedite lot disposition.

 

Real-time PCR (qPCR)-based assays can provide a viable alternative to the culture-based method and provide results in hours while still meeting Mycoplasma test performance guidance followed by regulatory bodies. Following validation, regulatory filing, and review, users worldwide and across multiple therapeutic modalities have received regulatory acceptance to use Applied Biosystems MycoSEQ Mycoplasma Detection Assays for lot-release testing.

Rapid Mycoplasma testing: Meeting regulatory requirements with confidence

This infographic explores the impact of Mycoplasma contamination and the most accurate and sensitive way to detect it.

Mycoplasma detection in cell therapy products: GMP-compliant implementation and validation



 

MycoSEQ Detection System: Regulatory track record

The following shows the regulatory acceptance track-record for the MycoSEQ Detection System* used for lot-release testing as of 2021.

Therapeutic drug category

Number of commercially released drugs

Number of drugs pending approval

Regulatory agencies granting approval

Cell and gene therapy

22

19
  • EMA (EU)
  • FDA (US)
  • PMDA (Japan)
  • Local agencies

Tissue therapy

3

0
  • EMA (EU)
  • FDA (US)
  • Local agencies

Recombinant protein

1

1
  • EMA (EU)
  • FDA (US)

Monoclonal antibodies

5

6
  • EMA (EU)
  • FDA (US)

Vaccines

3

4
  • MFDS (Korea)
  • Local agencies

Contract services and others

8

2
  • Local agencies

Total

42

32

 

EMA - European Medicines Agency; FDA - United States Food and Drug Administration; PMDA - Pharmaceuticals and Medical Devices Agency, Japan; MFDS - Ministry of Food and Drug Safety, Korea)
 

*MycoSEQ Detection System using SYBR-based MycoSEQ Mycoplasma Detection Assay Kit

On-demand webinars

Global Regulators' FAQs on CMC in IND/BLA Filing: A Retrospective Look at Past Mycoplasma Validation Queries and Responses

Every IND or BLA is different, as is every therapy being considered for regulatory approval. The CMC validation is a significant part of the regulatory filing, and interpretation of regulatory guidance is not always easy, with variability depending on the product. Thermo Fisher’s team takes a retrospective look at some of the commonly asked regulator’s questions regarding Mycoplasma testing and validation.

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials


In cell and gene therapy, materials matter. However, misconceptions abound, exacerbating a lack of harmonization and standardization in key areas. This presentation aims to debunk some popular myths, provide practical guidance based upon long experience in the field, and clarify key regulatory considerations and requirements across the cell and gene therapy raw and starting materials area.

Support throughout the validation process

Implementation and technical support

We are committed to the successful implementation of your MycoSEQ Mycoplasma Detection System—from initial process development through validation and routine use. Leveraging our years of expertise and successful track record, we will collaborate with your team to develop a comprehensive testing implementation plan. This can include:

  • Instrument installation with IQ/OQ
  • Computer System Validation (CSV)
  • Method/protocol optimization
  • Team training
  • Regulatory support

Regulatory consulting

For decades, Thermo Fisher Scientific’s extensive network of Field Application Specialists around the world has helped customers establish analytical assays that have satisfied regulatory guidelines, and our Regulatory Consulting Services specialists have provided customers with needed support when working with regulatory agencies.
 

Our team of consultants provide their industry experience to help address many of your bioprocessing and regulatory compliance challenges. They can:

  • Advise on the features of our products that enable alignment with regulatory guidelines
  • Support evaluation, implementation, and validation of bioproduction solutions
  • Provide guidance on regulatory strategy during implementation and qualification of bioproduction solutions
  • Provide consultation to support deviation or nonconformance investigations, including guidance on the development of CAPA

Additional expertise and supporting services include:
 


 Validation guidance
  • Consultation on validation, strategy, and approach
  • Assist in alignment with current industry guidance documents:
    International Committee for Harmonization (ICH), regional pharmacopeias (USP, EP, JP, CP), FDA Guidance for Industry, World Health Organization (WHO)
  • Review validation protocols, acceptance criteria, and reports
  • Validation support at Customer Experience Centers

 


 

 Regulatory support
  • Consult on regulatory strategy: Prior Approval Supplement (PAS), Type C, Chemistry, Manufacturing, and Controls (CMC) update
  • Review briefing documents and presentations
  • Organize informational meetings with key regulatory thought leaders
  • National Institute of Standards and Technology (NIST), Standards Coordinating Body (SCB)


Regulatory documentation
  • Submissions support documentation to enable regulatory filings in multiple jurisdictions
  • MycoSEQ Drug Master File (DMF) on file with FDA and Canada
  • Validation and comparability reports

Request a technical consultation

No matter your questions, we are here to help. Our experienced team of scientists and technical specialists is ready to assist you in choosing the right solution and products. Complete this form to start the conversation.
 

 

Analytics Knowledge Hub


Explore the Analytics Knowledge Hub from Thermo Fisher Scientific, providing a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize the use of our products in your bioprocess workflow.
 

Additional resources

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Learn, evaluate, connect.




 

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For Research Use Only. Not for use in diagnostic procedures.