ELISA test for batch potency testing of swine erysipelas vaccines

Topic: Quality control of vaccines

Test Method Number:

TM2001-01 (EU)

Short Name of TM:

ELISA ERY

Year received:

2001

Responsible Organisation:

EURL ECVAM - European Union

General Comments:

Method Description

The ELISA ERY measures antibody levels against erysipelas in the serum of mice immunised with inactivated swine erysipelas vaccine. It is carried out for vaccine batch release to demonstrate that the given vaccine batch complies with the requirements set in the marketing authorisation for the given vaccine.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Oct 2001	Not applicable	See Peer-review step

Validation

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Date	Stage	Comment	Documents/Links
Jan 1998	Not applicable	The validation study has been carried out externally during 1998-2000. EURL ECVAM participated in the study as laboratory and coordinated the Peer-Review later on. See Peer review step

Peer-review

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Date	Stage	Comment	Documents/Links
Oct 2001	Finalised	The ESAC peer reviewed the validation study.	Documents provided to ESAC
Jun 2002	Finalised	Issuing of the ESAC statement on the 18th Plenary meeting.	ESAC statement

Recommendation

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Date	Stage	Comment	Documents/Links
Jan 2004	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Jan 2004	Adopted/published	The method has been included into the European Pharmacopoeia - Monograph 064 on swine erysipelas vaccine in 2004.