Policy on Procurement of Custom Produced Monoclonal and Polyclonal Antibodies
BACKGROUND
Monoclonal and polyclonal antibodies are critical research reagents, which typically require immunization of a living animal host to be created. Due the to the fact that Wayne State University (WSU) holds an Office of Laboratory Animal Welfare (OLAW) Animal Welfare Assurance, OLAW requires that all custom produced antibodies procured by faculty must be obtained from organizations that also hold an Animal Welfare Assurance. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not those purchased off-the-shelf). In addition, documentation of the IACUC approved protocol used to produce the custom antibodies is required by OLAW. Finally, the organization must also be registered with the USDA, if the species used to produce the antibodies is regulated by the USDA-APHIS.
IACUC POLICY
In reviewing an application for custom polyclonal or monoclonal antibody production the WSU IACUC office must verify that the contracted agency or firm has a valid Animal Welfare Assurance and, if a covered species is involved, that the agency or firm is registered with the United States Department of Agriculture as a Research Facility. The production of the custom antibody cannot be ordered until these assurances are provided and verified by the WSU IACUC Office. The WSU IACUC Office maintains a list of approved companies (vendors) that produce custom antibodies that hold Animal Welfare Assurances.
REFERENCES
- Office of Laboratory Animal Welfare (OLAW), NIH. http://grants.nih.gov/grants/olaw/faqs.htm#App_2
- Office of Laboratory Animal Welfare (OLAW), NIH. https://olaw.nih.gov/guidance/obtaining-an-assurance.htm
Approved: April 27, 2022