About Us
Biogénesis Bagó is a global leader in biotechnology company in animal health, productivity, and welfare.
The company develops, manufactures, and markets world-class products to protect animal health status. It plays a key role in preventing zoonotic diseases and ensuring food production safety.
Biogénesis Bagó is recognized as a global leader in the prevention and control of foot-and-mouth disease and is one of the leading supplier of canine and feline rabies vaccine, with the capacity to respond immediately to animal health emergencies worldwide.
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FAQ
Section 1: BIOAFTOGEN® Product Overview
What is BIOAFTOGEN® and what strains does it cover?
BIOAFTOGEN® is a comprehensive portfolio of vaccines against Foot-and-Mouth Disease (FMD).
It provides protection against all seven known FMD virus serotypes: O, A, C, SAT1, SAT2, SAT3, and Asia1.
The vaccines are available in several formulations, ranging from monovalent vaccines (single strain) to multivalent combinations of up to six strains, allowing vaccination programs to be adapted to the epidemiological needs of each region.
What is the global reach and regulatory status of BIOAFTOGEN®?
BIOAFTOGEN® is licensed in more than 35 registrations across 30 countries on four continents, including regions in the Americas, Asia, the Middle East, and Africa.
It is also the first FMD vaccine to receive EuFMD-FAO prequalification (PQv22-001, September 2023).
Production follows GMP, ISO 9001, and ISO 14001 standards, and each batch undergoes independent release by the WOAH World Reference Laboratory at SENASA.
Is BIOAFTOGEN® a DIVA vaccine, and why is this important?
Yes, BIOAFTOGEN® is a highly purified, DIVA (Differentiation of Infected from Vaccinated Animals) vaccine.
It is completely free of non-structural proteins (NSP), which allows authorities to accurately differentiate naturally infected animals from those that have merely been vaccinated.
This differentiation is key for FMD control and eradication programs.
What is the shelf-life and stability of the vaccine?
BIOAFTOGEN® maintains stable potency for up to 24 months when stored under the recommended cold-chain conditions.
Section 2: Formulation, Potency & Efficacy
What type of emulsion is used in BIOAFTOGEN®, and what are its benefits?
BIOAFTOGEN® is formulated as a Single Water-in-Oil Emulsion (SOE). In this system, small droplets of aqueous antigen are dispersed within a continuous oil phase.
This formulation improves vaccine stability and helps generate a strong and long-lasting immune response.
When does immunity develop after BBIOAFTOGEN® vaccination?
Following BIOAFTOGEN® vaccination, the animal’s immune system begins to respond, and within approximately 7 days, a protective level of antibodies is usually achieved.
This effective immune response helps safeguard livestock against Foot-and-Mouth Disease, reducing the risk of infection and limiting virus spread, especially in the case of emergency when fat response is needed.
Does BIOAFTOGEN® interfere with maternal antibodies?
BIOAFTOGEN® is able to induce a strong level of immunity that overcomes the presence of maternal antibodies.
Studies in calves with high maternal antibody levels at 1 and 2 months of age have shown that the vaccine effectively stimulates protective immunity, ensuring that young animals are safeguarded against Foot-and-Mouth Disease even when maternal antibodies are still present.
How is the potency of BIOAFTOGEN® measured, and what are its levels?
Vaccine potency is measured in PD₅₀ (Protective Dose 50%) in cattle.
BIOAFTOGEN® is classified as a high-potency vaccine (≥32 PD₅₀). Examples of strain potency include:
- O1 Campos, A24, SAT2: ≥32 PD₅₀
- Asia 1: 97 PD₅₀
- A2001 and SAT1: ≥128 PD₅₀
These potency studies were performed by independent FAO reference laboratories, including Wageningen Bioveterinary Research (FAO reference lab) and The Pirbright Institute (WRLFMD).
What factors, besides the vaccine itself, determine the ultimate success of immunization?
While high GMP vaccine quality (antigen payload, stability, strain) is the foundation, total protection relies on several operational factors:
- Strict Cold Chain storage and transport.
- Animal Variability (the animal’s health, nutrition, and immune system).
- Good Vaccination Practices (proper application technique).
- Appropriate Vaccination Schedules.
- Validated Vaccine cross-protection against circulating field strains.
Section 3: Safety Profile
What is the safety profile of BIOAFTOGEN®?
The vaccine has a satisfactory safety profile and is safe across all species and productive stages (reproduction, production).
More than 110 million doses have been administered in Asia with no reported reactions.
The vaccine undergoes over 1,000 quality-control checkpoints including sterility, in vivo tests, and physicochemical analysis.
Is BIOAFTOGEN® safe for dairy cows?
Extensive trials and field observations have demonstrated that BIOAFTOGEN® is completely safe for use in dairy cows.
Vaccination does not affect milk production, rumination, or feeding behavior, ensuring that herd health and productivity are maintained while providing effective protection against Foot-and-Mouth Disease.
Is BIOAFTOGEN® safe for calves, and at what age should they be vaccinated
BIOAFTOGEN® is safe for young calves.
Under routine conditions, vaccination is recommended from 12 weeks of age to ensure the best immune response.
In emergency situations, however, vaccination can be administered at a younger age to achieve an early protective level of antibodies, helping to rapidly safeguard the herd and reduce the risk.
Is BIOAFTOGEN® safe for use in pregnant animals?
Yes, BIOAFTOGEN® is safe for use in pregnant animals and can be administered at any stage of production when used according to recommended guidelines of good vaccination practices.
Section 4: Dosage & Good Vaccination Practices
What is the proper dosage for different livestock species?
The dosage is 2 mL per dose for Cattle, Buffalo, and Swine, and 1 mL per dose for Sheep and Goats.
What are the recommended vaccination schedules?
Cattle: Primovaccination (PV) starting at 2 months of age, followed by revaccination 30 to 90 days later. After that, a booster dose is administered every 6 months.
Swine: PV at 4 weeks of age (or 4-8 weeks), revaccination 30 days later, and a booster every 6 months. For breeding stock, mass vaccinate every 6 months or 4 weeks before farrowing/service.
Sheep & Goat: PV at 4 weeks of age, revaccination 30 to 90 days later, and a booster every 6 months.
Can I administer BIOAFTOGEN® intramuscularly or subcutaneously?
Yes, it can be administered via Intramuscular (IM) or Subcutaneous (SC) injection.
The choice of route does not affect efficacy; both provide equivalent immune response and herd protection.
However, IM is recommended to minimize visible cosmetic defects, as SC injections deposit immediately under the skin and result in highly visible, palpable firm nodules lasting 30-90 days.
How often should the syringe be changed during vaccination?
Syringes should be replaced after vaccinating every 10–15 animals to ensure hygiene, prevent contamination, and maintain the safety and effectiveness of the vaccine.
What is the recommended injection site for swine?
For swine, it is highly recommended to inject in the neck (just behind the ear).
Injecting in the rump or gluteal region is not recommended because the thicker fat and muscle layers increase the incidence of abscesses, granulomas, and require carcass trimming.
If the neck cannot be used due to exceptional circumstances, inject into the semimembranosus or semitendinosus muscles after cleaning and disinfecting the area.
Is it safe to mix BIOAFTOGEN® with other vaccines?
Absolutely not. You must not mix oil-based vaccines with other vaccines.
Mixing damages freeze-dried viral antigens, blocks uniform dosing, risks causing granulomas or abscesses, and invalidates regulatory approval from bodies like WOAH and SENASA.
How must the vaccine be stored?
The vaccine relies on a strict cold chain and must be maintained at 2–8°C constantly.
Freezing damages the adjuvants by causing phase separation, while heat degrades the antigens and reduces immunogenicity.
Section 5: Post-Vaccination Reactions & Safety
What is the safety profile of BIOAFTOGEN®?
The vaccine has a satisfactory safety profile and is safe across all species and productive stages (reproduction, production).
More than 110 million doses have been administered in Asia with no reported reactions.
The vaccine undergoes over 1,000 quality-control checkpoints including sterility, in vivo tests, and physicochemical analysis.
How do I differentiate a normal vaccine reaction from an infection?
Because the single oil emulsion acts as an “engine of immunity,” a proportion of animals may develop a normal local reaction.
Sterile Vaccine Residue (Normal): Benign, firm or semi-solid (non-fluctuant), painless, cool, and non-inflamed. It resolves spontaneously over weeks or months and requires no intervention.
Abscess (Infection): Caused by secondary bacterial contamination (e.g., dirty needles or skin). It is fluctuant (soft), painful, hot, inflamed, contains pus, and requires drainage or antibiotics.
Section 6: FMD Outbreak Management & Diagnosis
What immediate biosecurity actions should a farm take during an outbreak?
Internal: Isolate clinical cases immediately, halt all movement of animals/visitors, implement separate lines (handle healthy animals first, sick animals last), change boots/gloves between groups, and document signs daily. Ensure clean water access to prevent dehydration.
External: Suspend commerce, alert neighboring farms, control vectors (rodents, birds, strays), and require vehicles to remain at the gate or undergo full disinfection.
What is the proper procedure for diagnostic sampling?
Samples should be collected from acutely affected animals.
Fresh lesions (<3-4 days old): Collect epithelium and place it in a viral transport medium (VTM) containing glycerol-phosphate buffered saline (pH 7.2–7.6) for RT-PCR, Ag ELISA, or Virus isolation.
Older lesions, fluid, or swabs: Can be placed in standard sterile containers for testing.
What are the differential diagnoses for FMD symptoms?
FMD is the primary suspect for vesicular lesions. However, other conditions can mimic FMD:
Foot Lesions Only: Dermatophilosis, Foot-rot, MCF.
Ulcerative Lesions: Bovine Virus Diarrhea (BVD), Mucosal Disease, Malignant Catarrhal Fever (MCF).
Non-Infectious: Trauma or chemical burns.
How should FMD-infected animals be medically treated?
Systemic: Administer Flunixin Meglumine (1x per day for 3 days) to relieve pain, inflammation, and fever. Antibiotics (like Oxytetracycline or Ceftiofur) should only be used for secondary infections.
Mouth Lesions: Use an Antiseptic Mouthwash (mix 100ml Chlorhexidine + 200ml water). Remove saliva, apply directly with a needle-less syringe daily for 5 days. Do not allow the animal to swallow it. Provide soft feed like rice gruel.
Hoof Lesions: Clean the lesion, then use a footbath of 500g Copper Sulfate dissolved in 10 liters of water. Soak the foot for 15 minutes, 1x per day for 5 days. Apply Gentian Violet afterward to repel flies.
How should the farm environment be disinfected?
The FMD virus survives between pH 6.0 and 9.0.
Disinfectants must push the pH outside this “Safe Zone” to either <6.0 (acidic) or >9.0 (alkaline).
Effective options include Sodium hydroxide (2%), Sodium carbonate (4%), Citric acid (0.2%), Acetic acid (2%), or Chlorine dioxide.
For un-cemented flooring, Lime can be used, ensuring the pH remains above 10.
In an emergency, which animals should be prioritized for vaccination?
Emergency vaccination protocols prioritize animals in a specific order:
Priority 1: Healthy Animals (to protect the vulnerable).
Priority 2: Exposed/Suspect Animals
Priority 3: Recovering Animals (only once they are stable).
Calves under 2 weeks during the outbreak should get their first shot at 2-4 weeks, and a second shot 3-4 weeks later.
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