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Non-animal Methods for Toxicity Testing

Biologics & Vaccines


Last Updated: April 1, 2013
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Validated Non-animal Alternatives

Last Updated: March 2013

In Vitro Method1

Test Purpose

Validation Authority2

Pharmacopeia or Agency3

Cell-based assay for botulinum neurotoxin type A products Stability and batch potency testing of biological

ICCVAM agency

US FDA: Allergan, Inc., method accepted (2011)

ELISA test for Leptospira veterinary vaccines Batch potency testing of vaccine

ICCVAM agency

USDA Supplemental Assay Methods 624, 625, 626, and 627 (2008)

ELISA test for swine erysipelas vaccines Batch potency testing of vaccine

ECVAM

ESAC (2002)

EDQM/EP Monograph 064 (2004)

USDA Supplemental Assay Method 613

ELISA test for human tetanus vaccines Batch potency testing of vaccine

ECVAM

ESAC (2002)

EDQM/EP (2003)

FDA, 21 CFR 610.10 (accepted on case-by-case basis)

Toxin binding inhibition (ToBI) test for human tetanus vaccines Batch potency testing of vaccine

ECVAM

ESAC (2002)

EDQM/EP (2003)

FDA, 21 CFR 610.10 (accepted on case-by-case basis)

In vitro monoclonal antibody production3,4 Not a test

ECVAM

ESAC (1998)

 

1Only non-animal methods are listed in this section. For additional alternatives that can reduce and/or refine animal use for biologics and vaccines see the Table of Validated and Accepted Alternative Methods.
2ECVAM ESAC Statements; ICCVAM table of US accepted methods
3EDQM/European Pharmacopeia; USDA Veterinary Biologics
4The ESAC released the following statement: "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).