Procurement of Custom Produced Monoclonal and Polyclonal Antibodies
Type
PolicyPolicy
Procurement of custom antibodies requires IACUC oversight.
Definition
Antibodies are considered customized if produced using antigen(s) provided by the investigator or at the request of the investigator (i.e. not purchased as a pre-made catalogue item off-the-shelf).
Background
Monoclonal and polyclonal antibodies are critical research reagents, which typically require immunization of a living animal host to be created. Using a commercial producer or requesting another research institution to produce your antibodies is acceptable. However, if your research requires customized antibodies, where you supply the antigen(s) to be used to raise the antibodies in an animal-based system, IACUC oversight is required. The Office of Laboratory Animal Welfare (OLAW) requires that all custom-produced antibodies procured by researchers must be obtained from organizations that also hold an Animal Welfare Assurance and be registered with United States Department of Agriculture (USDA) as a Research Facility, if the species used to produce the antibodies (e.g. rabbits) is regulated by the USDA-APHIS.
Procedure
The purchase of custom antibodies with a purchase card or other simplified acquisition method without IACUC involvement is permitted as long as the commercial vendor or other supplier has an approved PHS Animal Welfare Assurance and is registered with the USDA as a research institution if USDA-regulated species (e.g. rabbits) are used. A supplier’s PHS Animal Welfare Assurance status can be verified on the OLAW website: https://olaw.nih.gov/assured/app/index.html. A list of USDA registered institutions (search for "Class R - Research Facility") can be accessed here.
References
- Office of Laboratory Animal Welfare (OLAW), NIH. (Assurance)