Monoclonal Antibody Production
Methods for production of monoclonal antibodies include:
- In vitro culture
- Mouse ascites
It is an NIH expectation that in vitro methodology will be routinely used for generation of monoclonal antibodies. The following requirements must be met before IACUC will consider the use of the mouse ascites method:
The Principal Investigator (PI) must test each hybridoma cell line in vitro. If the attempt to generate monoclonal antibodies in vitro is unsuccessful, the PI must demonstrate that he/she has tried additional modifications in an attempt to adapt these cell lines in vitro. Such unsuccessful in vitro testing of a cell line and unsuccessful attempts to try to adapt the cell line in vitro would provide the scientific justification necessary to proceed with monoclonal antibody production in the mouse. The PI should maintain a detailed description of his/her efforts for review by the IACUC. The IACUC may consult with an outside specialist in immunology for assistance with the decision making process. In cases where the results of testing one hybridoma cell line may be generalized to others, there must be a verifiable scientific basis for the validity of such assumptions.
References:
Dear Colleague Letter, Production of Monoclonal Antibodies Using Mouse Ascites Method, November 17, 1997
Monoclonal Antibody Production. Washington DC, National Academy Press, 1999
Immunization Procedures and Adjuvant Products. ILAR 46(3), 2005.
