From Isolate to Autogenous Vaccine

What Is an Autogenous Vaccine Program?

An autogenous vaccine program is a structured, veterinarian‑guided process used to develop a custom vaccine from isolates collected from a specific disease case. At Kemin, this process is completed under USDA oversight and in collaboration with the prescribing veterinarian, from isolate submission through manufacturing and release.

How Does the Autogenous Vaccine Program Work?

The autogenous vaccine program begins with a disease case review and ends with delivery of a custom‑manufactured vaccine for that specific case. Each step is designed to support regulatory compliance, safety, and traceability while maintaining veterinary control throughout the process.

Autogenous Vaccine Program Model: Step‑by‑Step

Step 1: Case Review and Isolate Submission

A licensed veterinarian evaluates the disease challenge and determines whether an autogenous vaccine is appropriate.

Isolates are collected and submitted according to Kemin guidelines to support quality, traceability, and regulatory acceptance.

Step 2: Characterization and Project Planning

Submitted isolates are confirmed and characterized to support accurate formulation.

Kemin works directly with the prescribing veterinarian to discuss formulation considerations and alignment with the target species and production system.

Step 3: Manufacturing

Each autogenous vaccine is manufactured to order under USDA oversight.

Species‑appropriate formulations and adjuvant selections are made based on veterinary direction and regulatory requirements.

Step 4: Safety Testing and Release

All required safety and sterility testing are completed prior to release.

Once approved, the vaccine is released directly to the prescribing veterinarian.

Step 5: Shipment

Vaccines are shipped using temperature‑controlled methods to maintain product integrity through delivery.

Who Controls the Use of Autogenous Vaccines?

Autogenous vaccines are prescribed and used under the direction of a licensed veterinarian operating within a valid Veterinarian‑Client‑Patient Relationship (VCPR). These vaccines are produced in USDA‑licensed facilities and do not carry USDA‑approved efficacy claims. Use is determined at the discretion of the prescribing veterinarian.

Why Use a Structured Autogenous Vaccine Program?

A structured autogenous vaccine program helps ensure:

• Clear veterinary oversight
• Regulatory compliance
• Traceability from isolate to finished product
• Consistent execution across each phase of the process

The focus is on process discipline and collaboration, not outcomes or performance claims.

How Do You Start an Autogenous Vaccine Project?

To begin an autogenous vaccine project:

• Request isolate submission guidelines, or
• Contact Kemin to discuss next steps with your veterinarian

Start an Autogenous Vaccine Project

Request isolate submission guidelines or speak with our team about next steps.