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BioPhorum’s input on ICH guidance on products derived from cell lines of human or animal origin

1 April 2023
Drug Substance
Isabelle Lequeux
Program Manager – Regulatory Lead

The ICH has developed a second version of the Scientific Guideline, Q5A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. This document considers testing and evaluating the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package.

The ICH has asked for industry comments as part of the document’s public consultation, and our views have been published in BioPhorum Feedback on ICH Q5A (R2).

Upon review, the BioPhorum team confirms the new version is more detailed and contains further clarification, especially regarding new modalities, which will benefit industry.

As feedback to the committee, BioPhorum would like to see:

  • All modalities addressed (including advanced therapy medicinal products or cell therapies that use nanofiltration, which are currently not covered) and all platforms (including closed systems)
  • Fewer specific methods to be used, as they are unlikely to remain current in the next few years. The team therefore recommended that methods are described in more generic terms to avoid the rapid obsolescence of the guideline.

Overall, the team welcomed the new version of the guideline, as the previous one was more than 20 years old.

BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.

Some other points of feedback include:

  • More consistency of wording is required as some concepts are used interchangeably in the document that are actually significantly different
  • The document contains some critical information in appendixes and footnotes that would be beneficial to be included in the main body.

BioPhorum commends the committee on this initiative and was delighted to contribute to such an important discussion. BioPhorum’s answers are based on the extensive knowledge of its members; their feedback therefore reflects their broad analytical expertise and pursuit of innovation.

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