By Jennifer Shike and John Maday
For a special occasion, you might splurge on a custom suit. If you are rolling in cash, maybe a custom-built Italian sports car fits the bill. For veterinarians and livestock producers though, a custom vaccine isn’t an extravagance, but rather another tool in the box for addressing new or uncommon strains of livestock pathogens.
FDA-licensed commercial vaccines and bacterins from reputable suppliers generally provide safety and efficacy if handled and administered properly and can offer cross-protection against pathogen strains not used in production of the vaccine. However, when efficacy seems to decline, a custom or autogenous vaccine, containing antigens specifically targeted toward new or unusual strains of pathogens that can emerge locally, could provide a better, more specific immune response.
In the short term, diagnostic testing provides a scientific basis for treatments and management decisions to address diseases. In the longer term, identifying the pathogens involved helps veterinarians and producers design more effective vaccine protocols and preventive strategies. At Newport Laboratories, the process includes tests to identify and multiply specific isolates involved in an outbreak, for use in developing custom vaccines that target those exact strains. Diagnostic testing becomes more proactive, rather than reactive.
“Diagnostics show us what’s really going on – instead of just shooting from the hip clinically,” says Randy Shirbroun, DVM, and ruminant business unit director at Newport Laboratories. “A key component is making sure we have the right isolate.”
The following outlines the steps involved in the Newport Laboratories, Inc. custom-made vaccine manufacturing process, including sampling, diagnostics and post-administration follow-up.
This example explores the development of a custom bacterin for prevention of Streptococcus suis. The description represents a typical scenario, but the timeline and protocol can vary depending on the situation.
A Step-by-Step Guide to Craft a Custom Vaccine
Step 1. Conversation and Sample Collection (5-10 business days)
Herd veterinarian discusses herd health challenges with Newport Laboratories team member before collecting samples, completing necessary submission forms and shipping samples to Newport Laboratories using free diagnostics shipping kit.
Step 2. Isolation and Identification of Bacteria (3–5 business days)
Samples are streaked on a plate and cultured overnight. Individual colonies are identified and re-cultured until a pure isolate is attained. Isolates are then analyzed by MALDI-TOF to identify the specific pathogen. The MALDI-TOF speeds up the process by eliminating 24 hours of conventional bacteriological techniques to identify the organism species.
Step 3. Sequencing and Selection (7-14 business days)
Whole genome sequencing (WGS) is performed to identify specific strains present. Results are cross-referenced against a proprietary Newport Laboratories database to identify isolates best suited for custom-made vaccine creation. The WGS report is submitted to herd veterinarian along with a recommendation from Newport on the isolate(s) that should be included in the custom-made vaccine. Herd veterinarian discusses report and recommendation with a Newport team member and settles on desired order.
Step 4. Submit and Receive Order (Up to 5 business days for order processing)
Each isolate has a case number with it. Newport Laboratories includes each isolate number that goes into the vaccine. Opportunity to fine tune the order at this point.
Step 5. Manufacture Vaccine (33-48 calendar days)
Antigen growth and inactivation takes 16-27 days, followed by concentration for 8 days, batching for 5-9 days, and bottling for 4 days.
Step 6. Final Quality Control (14 calendar days)
Final quality control measures are put in to place, but quality control takes place throughout the entire process to make sure there aren’t any glitches. This helps ensure a quality product at each state of development.
Step 7. Ship to Customer (5-7 business days) (Product Bottle)
Step 8. Administration and Follow-Up (Upon receipt by herd veterinarian to approximately 90 days following administration*)
Herd veterinarian administers custom-made vaccine. A Newport Laboratories team member follows up with the herd veterinarian to discuss results and determine if further action is needed. The timing for follow-up is dependent on various factors, including the type of pathogen and when the custom-made vaccine is administered.
**Images by Newport Laboratories, Inc.
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