1. How does the custom vaccine process work?Show Answer
A: It starts with the veterinarian sending samples from animals with clinical signs of disease to our diagnostic lab for isolation of the disease causing strain(s). Once we have the isolate we will work with you to formulate a vaccine that best suits your herds or clients. We can create a multi-valent product with concentrated antigens, and precisely select the strains that we want to include in the vaccine.
2. How long does it typically take to make a vaccine or bacterin?Show Answer
A: The timeframe from outbreak to vaccination can vary depending on the organism, but a typical time from isolation to shipment is approximately 2 months.
3. How long can I use the same isolate?Show Answer
A: The USDA requires that isolates expire after 15 months from the time of isolation or 12 months from the time it is first used to make a product. An isolate extension request can be made to provide up to 2 years of use for that particular isolate. Cambridge Technologies will assist you in managing your isolates.
4. How do I send my isolates to you?Show Answer
A: The easiest way is to fill out a diagnostic submission for from our website. They can be found on the forms tab at the top. We will provide you with a free shipper box and swabs for your samples. You can also work directly with an account manager by calling 877.298.1321 or emailing firstname.lastname@example.org
5. Are autogenous vaccines subject to the same regulations as a commercially available vaccines?Show Answer
A: 9CFR113.113 goes through all the requirements for getting a facility licensed and producing autogenous vaccines. There are a lot of similarities between autogenous vaccines and commercial vaccines in that area. You have to have an approved facility that meets air handling, cleanliness, employee flow, and other requirements that is no different than for a commercial vaccine. Outlines of production have to be filed for how you manufacture a given organism. Standard operating procedures, types of media, growth requirements, and a range of other things have to meet government requirements. On cell culture for growing viruses you have to do adventitious agent testing to ensure there are no bacteria or virus in the cell culture, as well as karyology to make sure there are no genetic changes as you move out. The main difference is you cannot do efficacy studies or claim it is efficacious.
6. Which swine diseases can be better prevented using an autogenous vaccine in place of a commercial vaccine?Show Answer
A: Those diseases where there is no commercially available vaccine, and those viruses and bacteria where there is antigenic variation that might be different from what is in a commercial vaccine. SIV & PRRS for example; streptococcus suis has 35 different serotypes. Parisuis, erysipelas and others.
7. Because you cannot do efficacy studies on autogenous vaccines, what other steps does the company take to ensure product safety?Show Answer
A: We perform safety tests in the same way it is done for commercial vaccines. Every serial has to go into a lab animal model. In addition to that we work very closely with the veterinarian. Autogenous vaccines require the involvement of a veterinarian or another expert in the field to administer. We think the role of the vet is critical and we work closely with them in formulating the vaccines and looking at clinical responses to make sure the vaccine is doing what we want it to do.
8. Have the advancements in PCR and whole genome sequencing like next gen sequencing allowed you to create a more precise autogenous vaccine?Show Answer
A: Absolutely, in a diagnostic case it’s not unusual to get more than one bacteria of the same genospecies or the same with a virus. The newer technology helps us look at those organisms more carefully and decide which ones are included in a vaccine. We can look at antigenic differences in the organisms, and specific genes that are important parts of pathogenic mechanisms.