Questions & Answers

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1. How Long Does The Process Take?
2. What Is The Shelf-Life Of An Autogenous Bacterin?
3. How Long Is The Isolate "Good"?
4. Can An Autogenous Bacterin Only Be Used In The Herd Where The Original Isolates Were Found?
5. What If I Want To Use An Autogenous Bacterin But I Don’T Have Any Isolates Or Cultures?
6. I Currently Have Isolates At Another Company That Was Previously Making An Autogenous Product For Me. What Can I Do To Switch To Newport Labs?

Q. How long does the process take?

A. The time from isolate selection until release and shipment includes the production time and the mandatory quality control (QC) testing time. The time for the production component varies, primarily depending on the specific organism’s growth rate. In general the time required for SoliDose implantable products is 10 to 12 weeks.

Because of the inherent nature of the annual beef production cycle, for most diseases during beef production, whether it is calf scours or feedlot diseases, it takes a year to see the benefits from initiating the process to manufacture an autogenous bacterin. So the process requires conviction, persistence and patience.

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Q. What is the shelf-life of an autogenous bacterin?

A. According to USDA regulations, the shelf-life of all autogenous biologics is 18 months.

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Q. How long is the isolate "good"?

A. According to USDA regulations, each isolate has a finite lifetime, depending on when it was initially isolated or when it was first used to make an autogenous biologic. The isolate will "expire" 15 months from the time of isolation or 12 months after it was first used to make in a product, whichever is less. A request can be submitted to "extend" the dating of an isolate. If approved, the isolate extension provides a total use period of two (2) years. An isolate can be extended only once, so the maximum time an isolate can be used is two years from the date of isolation.

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Q. Can an autogenous bacterin only be used in the herd where the original isolates were found?

A. Typically an autogenous bacterin or vaccine is manufactured, and intended for use in the herd from which the original isolates were cultured. However the USDA allows the use of the product in other herds, upon formal request and approval. Non-adjacent herd use requires justification on the basis of epidemiology and the professional judgment of the veterinarian. The request for use in non-adjacent herds requires a list of those specific herds in which the product will be used. The product may not be used in herds for which permission has not been granted.

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Q. What if I want to use an autogenous bacterin but I don’t have any isolates or cultures?

A. By definition, an autogenous biologic is manufactured from isolates derived from tissues or samples submitted by the attending veterinarian. If no cultures or isolates are available, an autogenous biologic cannot be produced.

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Q. I currently have isolates at another company that was previously making an autogenous product for me. What can I do to switch to Newport Labs?

A. The veterinarian has the prerogative to request the other company to forward the isolate directly to Newport Labs. Every month we receive several isolates from other companies as veterinarians elect to switch the business to Newport.

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