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December 24, 2002

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 02-29

Subject: Availability of Monoclonal Antibodies from the

Center for Veterinary Biologics

To: Biologics Licensees, Permittees, and Applicants

Veterinary Services Management Team

Directors, Center for Veterinary Biologics

This notice is to inform interested parties of the Center for Veterinary Biologics’ (CVB)

policy for providing monoclonal antibodies (MAb) from CVB hybridomas. Monoclonal 

antibodies are a class of CVB supplied references and reagents. They are provided as 

testing aids as described in Title 9 Code of Federal Regulations, Part 113, Section 2 (9 

CFR 113.2) to assist veterinary biologics manufacturers to meet codified requirements,

and as a service to the U.S. veterinary biologics manufacturers for agents or procedures 

without codified requirements. Monoclonal antibodies may also be provided, as a 

courtesy, to colleges, universities, international scientists, non-U.S. veterinary biologics 

manufacturers, other U.S. and foreign regulatory agencies, and to U.S. allied industries to 

assist with biological related projects.

The CVB provides MAbs either as ascites fluid or a hybridoma supernatant. The CVB 

intends to continue to supply adequate volumes of MAbs to the U.S. veterinary biologic 

manufacturer for domestic use, where possible to other requestors, or for non-U.S. use. 

The CVB does not provide CVB origin hybridomas or restricted distribution hybridomas 

we have procured from other sources. When CVB origin hybridomas are released for 

distribution, they will be deposited with the American Type Culture Collection or a 

similar nationally recognized repository and will be available equally to all requestors. In 

certain cases, hybridomas have been patented by the Animal and Plant Health Inspection 

Service (APHIS) and APHIS personnel. Under those situations, distribution of 

hybridomas may be limited and shall meet the policies as established by APHIS. 

When inquiring about specific MAbs or inquiring if hybridomas have or are intended to 

be deposited, please contact the appropriate Section Leader at the CVB, phone number 

515-663-7331.

The CVB remains committed to supplying MAbs to assist in the regulatory control of 

U.S. veterinary biologics, especially where the CVB is the sole source of supply. Only 

under unusual circumstances do we anticipate that we will need to limit reasonable 

United States

Department of

Agriculture

Marketing and

Regulatory 

Programs

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary

Biologics

Suite 104

510 South 17th Street

Ames, IA 50010

(515) 232-5785

FAX (515) 232-7120
Center for Veterinary Biologics Notice No. 02-29 2

requests to less than the requested amount. The highest priority will be placed on 

requests from the U.S. veterinary biologic manufacturers for U.S. use and the CVB will 

be prioritizing production of MAbs based on most critical need and sole source supply. 

/s/ Richard E. Hill, Jr.

Richard E. Hill, Jr.

Director

Center for Veterinary Biologics