We work closely with our clients on their specific disease issues.

Autogenous biologics are recommended for emergency use only. They are prepared in response to a specific and immediate need, usually when a disease problem arises which is not amenable or responsive to the usual therapeutic measures or when licensed products are not available.

Autogenous biologics are prepared from cultures of microorganisms isolated from infected fish and are further described and characterized for the purpose of the Canadian Food Inspection Agency (CFIA) guidelines. These are as follows:

1. Autogenous biologic shall consist only of inactivated cultures or cell-free extract of microorganisms.

2. Each isolate from a diagnostic specimen shall be identified, at least to genus level.

3. Ordinarily, autogenous biologics shall be monovalent. However, an autogenous biologic containing multiple organisms may be prepared and used at the discretion of the attending licensed veterinarian. Autogenous biologics should not be mixed with licensed products because there are no supporting data to evaluate the impact of the autogenous product on the safety and efficacy of the licensed product.

4. These microorganisms are judged by the attending licensed veterinarian or diagnostic laboratory to be the cause of the current infectious disease. A proper veterinarian/client/patient relationship is a prerequisite to autogenous biologics use. The veterinarian will coordinate disease diagnosis, organism isolation and identification, and location for vaccine use. Associated diagnostic work may be undertaken at any laboratory with appropriate capabilities.

5. Each application for the autogenous biologic should be accompanied with information about the specific disease problem. Information such as, names, addresses and phone numbers of the company and attending veterinarian, date of the incidence, tentative diagnosis, dates of specimen collection and/or isolation of the causative agent should accompany the application. This information may be provided by the attending licensed veterinarian.

6. Autogenous biologics are to be used only at facilities from which the microorganism was isolated, or other adjacent or related facilities judged by a licensed veterinarian to be at risk.

7. Only the amount of autogenous biologic needed for the facilities at risk, not to exceed three inoculations, should be produced. Any autogenous biologic left over after final vaccination should be destroyed.

8. Each serial must be tested to verify safety, inactivation and freedom from contaminants.

In order to meet all of the CFIA guidelines, it is suggested that companies inform Microtek as soon as possible when a situation that requires an autogenous vaccine develops. Generally, if it is a disease issue that is recurrent, then two months is required to identify, grow the organism and perform the necessary quality control testing. If it is a new disease issue then more time will be required in order to satisfy CFIA guidelines.