When standard immunisation schemes do not yield the desired results, and bacterial challenges on the farm become specific, personalised solutions come to the fore. Why are autogenous vaccines considered a “point weapon” of veterinary medicine? How are drugs developed for a specific epizootic situation, and what is their strategic advantage for modern poultry farming?
We talk about the intricacies of creating and implementing individual solutions for poultry protection with Oksana Sen, Head of the Bacterial and Autogenous Vaccines Sector, Department of Development of Immunobiological Preparations, BIOTESTLAB LLC.
The full text of the interview is published in the magazine “Our Poultry Farming” (No. 3, 2025)
— What is an autogenous vaccine? How is it different from commercial vaccines?
— The term “autogenous vaccine,” or “autogenous immunobiological veterinary medicinal product,” refers to a specific prophylactic agent created from a microorganism isolated from a sick animal. This vaccine is intended for use in the affected animal or in a population of animals that have been in contact with the sick animal on the same farm.
In other words, autogenous vaccines are developed specifically for a single farm or a group of farms that are epizootically related. These vaccines contain strains from various pathogens or different antigenic variants of a single pathogen. Additionally, the composition of the vaccine can be adjusted to include new strains if conditions on the farm change.
— When is it most appropriate to use autogenous vaccines?
— These vaccines fill gaps left by commercial vaccines and are most appropriate for use in the following situations:
- when commercial vaccines are not available;
- when commercial vaccines do not contain antigenic variants circulating in the farm, and there is no cross-protection between them;
- in severe mixed infections;
- in case of increased resistance to antibiotics or as an alternative to them.
Some genera of microorganisms have numerous species and strains, and, of course, it is impossible to include all pathogenic strains in a single vaccine. Most often, manufacturing companies use the most common strains, which are effective for most farms due to cross-protection. However, in some cases, the disease may be caused by less common strains whose antigens are not included in commercial vaccines.
Thus, several commercial vaccines against salmonellosis are available on the market. However, in nature, more than 20 Salmonella serotypes are considered highly pathogenic. What is the probability that a vaccine produced in Germany, Israel, or the USA will contain exactly the serotype that is common in a certain region of Ukraine? In addition, the infectious process often involves several groups of pathogens. For example, pathogenic strains of Escherichia coli may be isolated along with Salmonella. There is no commercial vaccine that would be effective in such a situation.
— Is this vaccination an alternative to the use of antibiotics?
— Antibiotics are an easy solution for farmers dealing with poultry health issues. However, their widespread use can lead to an increase in antibiotic resistance among pathogens, which reduces the effectiveness of these drugs. As a result, farmers may have to use stronger antibiotics in higher doses next time. The increased resistance of bacteria also poses a threat to human health. As a result, autogenous vaccines have emerged as an alternative prevention method. However, this approach demands more time and effort compared to antibiotics, which can be administered immediately.
In the EU, autogenous vaccines have become widespread in the poultry industry over the last decade, due to the implementation of strategies aimed at reducing the use of antibacterial drugs. Global vaccine manufacturers are investing in laboratory diagnostics, development, and production of autogenous immunobiological products.
— For what types of birds are autogenous vaccines used?
— We are talking about preventive vaccination of long-lived birds: laying hens, breeding birds, as well as turkeys, domestic waterfowl (ducks, geese).
The production process for these vaccines is lengthy. For example, the company "BIOTESTLAB" takes 40 to 45 days from the moment it receives the pathological material for research until the finished product is shipped. Birds receive vaccinations twice (with a revaccination usually done after 21 days). Additionally, it takes another 3 to 4 weeks for the birds to develop immunity.
— What diseases are most often the objects of development of autogenous vaccines by BIOTESTLAB?
— We specialise in working with pathogens that cause bacterial diseases in poultry, producing autogenous vaccines under the brand name Polimun Autovac. One of our most popular vaccines is Polimun Autovac Salmo3, which includes two strains present in the commercial Polimun Salmo vaccine (Salmonella enteritidis and Salmonella typhimurium), and an additional strain isolated on a specific poultry farm.
We often receive orders for vaccines against escherichiosis (E.coli) and ornithobacteriosis (ORT), the causative agent is Ornithobacterium rhinotracheale. This is a gram-negative rod-shaped bacterium with a large number of serotypes, difficult to diagnose, and also very insensitive to antibiotics. Our work also focuses on the vaccine prevention of diseases such as pasteurellosis (caused by Pasteurella spp.), hemophilosis (caused by Avibacterium paragallinarum), and riemerellosis (caused by Riemerella anatipestifer), among others.
— How did the idea of producing autogenous vaccines come about?
— The company "BIOTESTLAB" has been producing autogenous vaccines since 2015. In addition to poultry vaccines, we offer vaccines for pigs, cattle, small cattle, and rabbits. This was a logical step to expand our product lineup, considering the level of technology we have achieved and market demand. By the way, we developed and manufactured the first autogenous vaccine for poultry against ornithobacteriosis at the request of one of our clients.
— What does the production cycle of an autogenous vaccine look like?
— The complete protocol consists of a series of sequential steps:
- Selection of materials for study;
- Isolation and typification of the pathogen;
- Evaluation of the feasibility of producing an autogenous vaccine;
- Coordination of production volumes, timelines, and costs;
- Signing of the agreement;
- Production of the vaccine and its delivery to the customer;
- Application through vaccination and revaccination as per the developed scheme;
- Study of the drug's effectiveness.
Several parties are involved in this process: the farm's veterinarian, the diagnostic laboratory, and the vaccine manufacturer.
— What is the role of the veterinarian in this process?
— A veterinarian plays a crucial role in identifying the clinical process, collecting and sending materials to the laboratory, and monitoring vaccine use. It is essential to conduct reactogenicity tests before vaccination. To do this, the drug is tested on a group of birds (at least 10 heads). If there is no inflammation or redness at the injection site within 24 hours, the birds are tolerating the vaccine well, and it can be used for other birds in the flock. It is crucial to monitor the dosage (0.5 ml per head) and the timing of revaccination. Following these and other recommendations outlined in the drug's instructions will help ensure the development of strong immunity.
As a manufacturer, we provide comprehensive support throughout the entire process. Starting from the first stage, when a company specialist visits the poultry farm to assess the situation, helps with the selection of pathogenic material, our support continues as we monitor the vaccine's immunogenicity, and evaluate its effectiveness after use. To achieve this, blood samples are taken from vaccinated birds after a certain time for serological testing. This testing assesses the levels of antibodies against the pathogens contained in the vaccine, along with evaluating the production indicators of the flock before and after vaccination.
— How important is laboratory diagnostics in the process of preparing for vaccine production?
— To develop an autogenous vaccine, it's essential to make an accurate diagnosis, isolate and typify (characterise) strains, and deposit them (keep them viable). The laboratory will recommend the type and number of samples to collect. A comprehensive differential diagnosis is performed to identify all pathogens capable of causing the clinical process, given that, as stated above, many pathologies are multifactorial. We cooperate with the "Center for Veterinary Diagnostics". This is a modern research center focused on identifying the causes of animal and poultry diseases, as well as conducting laboratory monitoring to assess the effectiveness of preventive and therapeutic measures.
— What does the process of producing an autogenous vaccine look like?
— The company "BIOTESTLAB" is the only one in Ukraine that produces autogenous vaccines using industrial technologies following the requirements of GMP (Good Manufacturing Practice). Therefore, we can produce autogenous vaccines in large batches, up to 300,000 doses. We constantly invest in development. In particular, a new, more effective technology for accumulating bacterial mass and its exotoxins was recently introduced. We have the know-how.
By the production method, autogenous vaccines for poultry are inactivated, meaning they are developed using a live pathogenic bacterium that is inactivated (“killed”) so that it can no longer reproduce. This means that when introduced, the pathogen is strong enough to elicit a robust immune response but does not cause disease. The vaccine contains an adjuvant. This is a substance that stimulates the formation of immune protection. After vaccination, the pathogen enters a slowly dissolving capsule in the bird's muscle tissue, triggering a more robust immune response.
The production involves several processes, each controlled by specific indicators. Once the material is received from the diagnostic laboratory, the culturing of strains and microorganisms begins to generate the required number of doses. We have developed a special culture medium on which almost the entire spectrum of bacteria we use grows. We accumulate bacterial mass in special containers. At the same time, we control the quality of the cultures, the absence of contamination, and confirm the required concentration of the pathogen. If the number of live bacteria in the dose corresponds to the protective level, inactivation is carried out. Various chemical methods are used for this purpose. Next come the processes of concentration and emulsification, that is, the combination of bacteria in the aqueous phase with the oil phase (adjuvant). The finished vaccine is packaged. Depending on the order, we use bottles of different sizes, usually 500 or 1000 doses.
— Are there any restrictions on the storage, transportation, or expiration date of such vaccines?
— The shelf life of autogenous vaccines is shorter than that of commercial vaccines, at 1 year. Other requirements are similar to those for commercial inactivated vaccines: transport and store at 2-8°C, and do not freeze. Once the first withdrawal from the vial is made, the vaccine should be used within 10 hours. It can be administered via intramuscular injections (into the chest or thigh muscle groups) or subcutaneous injections (into the lower neck or between the shoulder blades). The route of administration is similar – intramuscularly (into the chest or thigh muscle groups) or subcutaneously (into the lower neck or between the wings).
— What is the approximate cost of one dose of the vaccine, and what does it depend on?
— The cost of an autogenous vaccine is either the same or slightly higher than that of a commercial vaccine, potentially by up to 10%. This depends on several factors: the composition, which may include up to five pathogens; the size of the order; and the packaging, as vaccines in 1000-dose vials are cheaper than those in 100- or 200-dose vials. Additionally, the farm is responsible for paying for diagnostic services.
— What regulatory requirements must be met when producing autogenous vaccines in Ukraine?
— We work following the European Pharmacopoeia. This is a legal act used in most European countries in the production of pharmaceutical products. The Pharmacopoeia covers descriptions of active and auxiliary substances, along with analysis methods. For vaccines, these include studies on sterility, immunogenicity, and safety. We perform these tests in our laboratories and vivarium.
In Ukraine, autogenous vaccines do not require registration.
— What new developments in the field of autogenous vaccines does the company plan to introduce soon?
— Each autogenous vaccine is a separate research project. It is essential not only to type pathogens, but also to select inactivators and adjuvants. Work is currently underway to develop vaccines against staphylococcal infections in chickens, pseudomonosis in turkeys, and pasteurellosis in waterfowl. To provide the farm with a vaccine developed using proven technology if the pathogen is detected.
— Who orders autogenous vaccines most often: large farms or medium-sized ones?
— Among our clients are agricultural holdings, medium-sized, and small farms.
— How effective is an autogenous vaccine under real production conditions?
— Let's revisit the Salmonella vaccine. This disease adversely affects poultry productivity and can lead to mortality. According to government guidelines for the prevention and eradication of this disease, if Salmonella serotypes harmful to human health are detected in poultry, all birds — including breeding and parent flocks, as well as healthy young flocks from the affected poultry house — must be slaughtered and sent for industrial processing or disposal. This results in significant losses. However, birds vaccinated against salmonellosis develop immunity, allowing them to reach their genetic potential and demonstrate performance according to the stated standards of the cross.
Productivity significantly decreases due to Pasteurellosis, Escherichiosis, Ornithobacteriosis, and other diseases. Additionally, farms incur expenses on antibacterial therapy, which must be administered in multiple stages. Experience shows that preventive vaccination is much cheaper than treatment.
Thus, autogenous vaccines are a useful, and sometimes the only, tool in modern poultry health and welfare management strategies. When used correctly, they are highly effective in preventing many infectious processes and are highly cost-effective.