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In vitro production of monoclonal antibodies (hybridoma technique)

Topic : Human health

Test Method Number: TM1998-04 (EU)
Short Name of TM: In vitro mAbs
Year received: 1998
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Method Description

Based on the conclusions and recommendations of ECVAM workshop report 23 (Marx et al, 1997, ATLA, 25 121-137) and a report on monoclonal antibody production (Hendriksen, 1998, ATLA 26, 523-540), the ESAC concluded that for all levels of monoclonal antibody production, scientifically acceptable in vitro methods (e.g. hybridoma techniques) are practicably available. These methods have been shown to be either better than, or equal to, the in vivo (ascites) production method in terms of antibody quality. Therefore, the in vivo production of monoclonal antibodies by the ascites method is no longer scientifically necessary, except in rare cases.

Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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