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VB-GL-3.16: Registration of immunoglobulin products

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1. Introduction

The purpose of this guideline is to provide information to veterinary biologics manufacturers and importers regarding the licensing or registration of immunoglobulin products such as antibody products and colostrum. These products are classified as veterinary biologics (VB), and are regulated by the Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA) under the legal authority of the Health of Animals Act and regulations.

To fulfill licensing requirements, VB products must be shown to be pure, safe, potent and efficacious when used according to the label recommendations. Manufacturers must submit a detailed description of manufacturing and testing methods, proposed labelling, and supporting data as described in VB-GL-3.1: Preparation of new product licensing (registration) submissions for veterinary biologics and ordered as listed in VB product submission checklist – Antibody products. Upon fulfilment of the licensing requirements, the CCVB issues a VB product licence for the manufacturing, sale and distribution of the product.

The CCVB's licensing requirements for immunoglobulin products are similar to those of the United States Department of Agriculture, Center for Veterinary Biologics (USDA-CVB), and data submitted to the USDA-CVB is generally acceptable to meet Canadian requirements. The CCVB requires that immunoglobulin products originating in the United States be manufactured in USDA-CVB licensed facilities, and licensed with the CVB.

1.1 Legal authority

2. Potency and efficacy requirements

Nonspecific immunoglobulin supplements

Products intended for use as nonspecific immunoglobulin supplements must be shown to contain a consistent quantity of immunoglobulin which is satisfactorily absorbed when the product is administered according to label directions. This involves:

Specific antibody supplements

For products with a specific disease prevention claim, the basic immunoglobulin assay and absorption data would need to be supplemented by:

For example, a product intended for use as an aid in preventing enteric colibacillosis in calves would require:

3. Colostrum supplements and replacers

It has been reported that 'normal' bovine colostrum typically contains at least 50 grams of immunoglobulin per liter, and 'normal' suckling calves typically consume between 100 to 300 grams of immunoglobulin, so that post-suckling serum immunoglobulin concentrations are usually in the range of 10 mg/mL, or more. Due to the difficulty in manufacturing colostrum replacers with sufficient immunoglobulin to match the levels in normal colostrum, these products are usually labelled for use as colostrum supplements, rather than colostrum replacers. Products intended for use as colostrum supplements in calves should contain at least 50 grams of total immunoglobulin per dose. Products intended for use as colostrum supplements in other species should contain comparable antibody concentrations. Products intended for use as colostrum replacers should contain 100 to 150 g of immunoglobulin per dose and raise serum antibody levels above 10 mg/mL.

For calves, serum immunoglobulin levels below 10 mg/mL would generally be considered indicative of partial failure of passive transfer of immunoglobulins, and levels below 5 mg/mL would be classified as severe failure of passive transfer. Absorption studies should, therefore, attempt to demonstrate post-feeding serum antibody levels in the range of 10 mg/mL, or higher.

4. Contact information

Any further questions or clarification regarding the regulations and requirements pertaining to immunoglobulin products including bovine colostrum may be directed to the CCVB.

5. References

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