Biologics & Vaccines
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| Last Updated: December 6, 2007 |
| Validated Non-animal Alternatives
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Methods |
Test Purpose |
Validation Authority |
Pharmacopeia |
| ELISA test for erysipelas vaccines |
Batch potency testing of vaccine |
ECVAM |
EDQM/EP |
| ELISA test for human tetanus vaccines |
Batch potency testing of vaccine |
ECVAM |
EDQM/EP |
| Toxin binding inhibition (ToBI) test for human tetanus vaccines |
Batch potency testing of vaccine |
ECVAM |
EDQM/EP |
The European Centre for the Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC) released the following statement regarding biologics: "For all levels of monoclonal antibody production, scientifically acceptable in vitro methods are now 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" (ESAC Statement, May 14, 1998).
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