| HS Code | 174894 |
| Productname | Coccidiosis Quadrivalent Vaccine for Chickens, Live (E. tenella Strain PTMZ, E. necatrix Strain PNHZ, E. maxima Strain PMHY and E. acervulina Strain PAHY) Veterinary Grade API |
| Productcategory | Live coccidiosis vaccine veterinary biological API |
| Valency | Quadrivalent |
| Targetspecies | Chickens |
| Includedorganisms | Eimeria tenella Strain PTMZ; Eimeria necatrix Strain PNHZ; Eimeria maxima Strain PMHY; Eimeria acervulina Strain PAHY |
| Antigenformat | Live attenuated Eimeria oocysts |
| Diseaseindication | Induces active immunity against avian coccidiosis caused by Eimeria tenella, Eimeria necatrix, Eimeria maxima, and Eimeria acervulina |
| Mechanismofaction | Stimulates the chicken gut-associated immune response through controlled exposure to live Eimeria organisms |
| Availabledosageforms | Tablets; injections; capsules; powders; granules; premix; solutions |
| Grade | Veterinary grade API |
| Formulationrole | Active pharmaceutical ingredient intended for the compounding or manufacture of veterinary coccidiosis vaccine products |
| Administrationvector | Chicken-specific live vaccine formulation requiring veterinary protocol |
| Biosafetyconsideration | Contains live biological organisms and requires appropriate cold-chain and handling precautions |
| Strainbreadth | Covers four pathogenic Eimeria species associated with intestinal coccidiosis in poultry |
As an accredited Coccidiosis Quadrivalent Vaccine for Chickens, Live (E. tenella Strain PTMZ, E. necatrix Strain PNHZ, E. maxima Strain PMHY and E. acervulina Strain PAHY) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged 1 kg per sealed, desiccant-containing, light-resistant container; veterinary-grade coccidiosis quadrivalent live vaccine API for tablets, injections, capsules, powders, granules, premix, or solutions. |
| Container Loading (20′ FCL) | One 20′ FCL loaded with live Coccidiosis Quadrivalent Vaccine veterinary API in temperature-controlled, sealed, pharmaceutical-grade containers for various dosage forms. |
| Shipping | Ship live coccidiosis quadrivalent vaccine under strict cold chain (2–8°C), avoiding freezing and light exposure. Pack in validated insulated containers with gel packs. For veterinary use only. Comply with IATA and national regulations for biological substances, ensuring leakproof, labeled secondary packaging. |
| Storage | Store under refrigerated conditions at 2–8°C. Protect from light, moisture, and freezing. Keep containers tightly sealed in a dry, well-ventilated area, away from direct sunlight and heat. Avoid prolonged exposure to elevated temperatures. Use aseptic handling to prevent contamination. Do not use beyond expiration date. Keep out of reach of children. |
| Shelf Life | Shelf life is typically 18 months when stored at 2–8°C, protected from light, per stability data for this live vaccine. |
Commercial cabinet spray administration of the quadrivalent live oocyst concentrate is typically initiated only after the incoming bulk API has been verified against the strain-specific identity requirements of Ph. Eur. 0446 and the purity criteria of 9 CFR Part 113. The concentrate is equilibrated to 18–22 °C for 15–20 minutes and diluted with a buffered vehicle containing 0.85% w/v sodium chloride and 5.0% v/v glycerol to a final working volume of 200–250 mL per 1,000 chicks. Cabinet spray machines fitted with flat-fan nozzles are calibrated to deliver 0.20–0.25 mL per chick at a line pressure of 2.0–2.5 bar, producing a volume mean droplet diameter of 80–150 µm. The downstream process requires continuous low-shear recirculation at 120–200 rpm because sporulated Eimeria oocysts of 15–30 µm settle rapidly in unstabilized buffers. Recirculation lines are maintained at 2–8 °C if hold time exceeds 30 minutes, and chlorine contact must be excluded because free residual chlorine at >0.1 mg/L reduces excystation competence. Process validation for this route includes enumeration of sporulated oocysts per sprayed droplet by McMaster counting at 100× magnification and a pre-spray viability check using bile-trypsin excystation with a threshold of not less than 70% excysted sporozoites at 37 °C. The terminal product is a unit-dose hatchery spray suspension supplied in opaque polypropylene vials, and the formatted dose volume is 0.25 mL per chick unless cabinet airflow rate exceeds 12 m/s, in which case the dose volume is increased to 0.30 mL while preserving the oocyst count per chick.
In chlorinated drinking-water distribution lines, the limiting parameter is not the oocyst concentrate itself but the oxidation state of the incoming water. Drinking-water mass administration requires that free chlorine residual above 0.1 mg/L be neutralized with a 0.1% w/v sodium thiosulfate solution at 1–2 mL/L, with the resulting thiosulfate-to-chlorine stoichiometry checked by a chlorine test kit having a detection limit of 0.02 mg/L. The quadrivalent concentrate is then diluted in a medicated header tank at a ratio of 1 dose per 0.5–1.0 mL of final drinking solution, with a flock-level administration window of 2–4 hours at ambient temperature 18–25 °C. The downstream process uses a proportioner calibrated to 1:100 or 1:200 stock dilution, and the stock solution is stirred at 60–100 rpm using a marine impeller to avoid oocyst rupture. Compliance for the final drinking solution is aligned with the biological intermediate requirements of EudraLex Volume 4 Annex 2 and the water quality provisions of the WOAH Terrestrial Manual for live protozoal vaccines. Terminal product types include a concentrated water-stock suspension in opaque HDPE carboys and a ready-to-drink solution for nipple drinker or bell drinker systems. A second process constraint appears when well water contains ferrous iron above 0.3 mg/L; in that configuration the vaccine vehicle must be pre-treated with a chelating agent such as 0.05% w/v citric acid, because iron precipitates on the oocyst wall and interferes with sporozoite release.
Gel droplet administration requires a shear-thinning vehicle that can suspend oocysts uniformly during pumping yet recover viscosity quickly after droplet formation. A typical vehicle is prepared from deionized water with 0.35–0.50% w/v gellan gum or 0.4–0.6% w/v sodium carboxymethylcellulose, chilled to 10–15 °C to raise dynamic viscosity to 200–600 mPa·s at 10 s⁻¹. The quadrivalent oocyst concentrate is added at a ratio of 1 part concentrate to 9 parts gel vehicle, yielding a unit droplet volume of 0.025–0.030 mL per chick. Droplet formation is performed through a 1.2–1.5 mm nozzle at 0.8–1.2 L/h using a rotary peristaltic pump, and the droplets are collected in vented hatchery boxes. Uniformity of delivered dose complies with Ph. Eur. 2.9.36 when the coefficient of variation for droplet mass remains below 5.0% across 20 sampled droplets. Process control includes periodic oocyst enumeration by McMaster counting at 100× magnification to confirm that no zone of the gel hopper exceeds ±10% of target oocyst count per droplet. Terminal product formats include pre-filled single-dose gel droppers and bag-in-box gel feed for automated droplet dispensers.
When embryonated eggs reach day 18.0–18.5, the in ovo administration route is selected for hatcheries that require simultaneous delivery of coccidiosis vaccination and injection of day-old chick vaccines. The working suspension is prepared by diluting the bulk oocyst concentrate 1:1 with sterile phosphate-buffered saline to a viscosity below 10 mPa·s, then passing the suspension through a 100 µm stainless-steel screen to remove aggregates without reducing oocyst concentration. Automated in ovo injection platforms are calibrated to deliver 0.05 mL per egg into the amniotic sac using a 21G or 22G needle at a cadence of 20,000–35,000 eggs/h. Needle change intervals are not extended beyond 2 hours to limit bore corrosion and shear damage to sporulated oocysts. The final oocyst count per egg is maintained in the 102–103 sporulated oocyst range, with E. tenella and E. necatrix counts held at the lower end to limit early pathology. The terminal product is a conditioned in ovo injectable suspension in single-use sterile sachets, validated for bacterial endotoxin limits under Ph. Eur. 2.6.14 and live biological agent identity under Ph. Eur. 0446. Published strain-specific oocyst count limits for in ovo delivery are less standardized than for coarse spray, and end users are advised to verify the count against the marketing authorization file. The primary process conflict is needle shear at the injection manifold: if platform cadence exceeds 35,000 eggs/h, oocyst wall integrity may decline by more than 15% as measured by reduced excystation index.
| Application route | Working dilution and dose volume | Critical process parameter | Terminal product format |
|---|---|---|---|
| Hatchery cabinet spray | 200–250 mL per 1,000 chicks; 0.20–0.25 mL/chick | Droplet VMD 80–150 µm; recirculation 120–200 rpm | Unit-dose spray suspension in opaque PP vials |
| Drinking water | 1 dose per 0.5–1.0 mL; stock 1:100 to 1:200 | Free chlorine <0.02 mg/L; stir 60–100 rpm | Water-stock suspension; ready-to-drink solution |
| Gel droplet | 1:9 concentrate-to-gel; 0.025–0.030 mL/chick | Viscosity 200–600 mPa·s at 10 s⁻¹ | Pre-filled gel dropper; bag-in-box gel |
| In ovo | 1:1 dilution; 0.05 mL/egg | Needle 21G–22G; cadence 20,000–35,000 eggs/h | Single-use sterile sachet suspension |
| Feed spray | 1 dose/chick; 2–3% w/w overlay | Nozzle 0.8–1.0 mm at 1.0–1.5 bar | Vaccinated starter crumble; feed-spray suspension |
| Oral drench | 0.5–1.0 mL per bird | Viscosity 30–80 mPa·s at 25 °C | Multidose oral drench; foil-sealed cup |
For feed-spray applications at placement, the live oocyst suspension is combined with a food-grade adhesive such as 0.75–1.0% w/v xanthan gum or 1.0–1.5% w/v pregelatinized starch and sprayed onto starter crumble at 2–3% w/w of the initial feed mass. The feed-spray process uses a low-pressure nozzle with a 0.8–1.0 mm orifice at 1.0–1.5 bar, producing a wet overlay on the first 300–500 g of feed per 100 chicks. Addition ratio is calibrated to deliver 1 dose per chick without exceeding 12% w/w moisture in the carrier feed; immediate placement and consumption within 2 hours are required because oocyst viability on warm feed declines as water activity falls below 0.85. Compliance is governed by feed hygiene requirements under Regulation (EC) No 183/2005 and the veterinary biological product intermediate requirements of EudraLex Volume 4 Annex 2. The dominant process conflict is the balance between adhesive viscosity and oocyst settling: xanthan gum at >0.9% w/v stabilizes oocysts for 45–60 minutes but increases nozzle blockage. Terminal product formats include a vaccinated starter-cumble overlay in chick boxes and an on-farm feed-spray suspension mixed immediately before use.
Oral drench delivery is selected for individual bird vaccination of replacement pullets or breeder candidates where hatchery-level spray is not feasible. The quadrivalent oocyst concentrate is diluted to a dosing volume of 0.5–1.0 mL per bird using a suspending vehicle containing 0.3% w/v sodium carboxymethylcellulose and 0.9% w/v sodium chloride, with final viscosity maintained between 30 and 80 mPa·s at 25 °C. The downstream process uses a positive-displacement dosing syringe calibrated to ±2% volume accuracy across 1,000 actuations, with intermittent stirring at 150 rpm to prevent oocyst sedimentation in the holding tank. Terminal product types include multidose oral drench bottles and foil-sealed unit-dose drench cups for pullet operations. Uniformity of delivered dose complies with Ph. Eur. 2.9.27 for multidose preparations, and the formulation is released only after confirming that oocyst count per dose remains within ±10% of the label claim following 8 hours of intermittent stirring at 20–25 °C.
Competitive Coccidiosis Quadrivalent Vaccine for Chickens, Live (E. tenella Strain PTMZ, E. necatrix Strain PNHZ, E. maxima Strain PMHY and E. acervulina Strain PAHY) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
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The product under discussion is a bulk live anticoccidial vaccine antigen concentrate identified as Coccidiosis Quadrivalent Vaccine for Chickens, Live (E. tenella Strain PTMZ, E. necatrix Strain PNHZ, E. maxima Strain PMHY and E. acervulina Strain PAHY) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions. The strain string functions as the model identifier; no additional pharmacopoeial code is assigned. This is a biological active pharmaceutical ingredient, not a finished vaccine, and the four strain designations refer to master seed isolates used to generate sporulated oocysts. Although the listed presentation routes include tablets and injections, the viable sporulated oocyst is not suitable for parenteral administration or compression tableting. Tablet compression above 40 MPa and residual granule moisture below 3% w/w are incompatible with sporozoite viability; injection bypasses the intestinal mucosa, where the Eimeria life cycle must occur. The oral route is the only route consistent with regulatory dossiers for live anticoccidial vaccines. Powders, granules, premixes, solutions, and drinking-water presentations are feasible only when thermal and chemical stress are controlled.
For a live quadrivalent Eimeria API, release testing should include identity, oocyst enumeration, sporulation rate, bacterial and fungal enumeration, and absence of specified pathogens. Species identity is commonly confirmed by species-specific polymerase chain reaction targeting the internal transcribed spacer 1 or mitochondrial cytochrome oxidase I loci; oocyst enumeration uses a McMaster counting chamber under 100× to 400× phase-contrast microscopy. Sporulation rate is determined by differential counting of sporulated and unsporulated oocysts, with a release limit of not less than 80% sporulation typical for live oocyst concentrates. Viability can be verified by excystation in trypsin and sodium taurodeoxycholate in Hanks' balanced salt solution at 41°C for 60 min, followed by hemocytometer counting of motile sporozoites. Microbial enumeration follows Ph. Eur. 2.6.13 or USP <61>/<62>; acceptance limits are product-specific and must appear on the certificate of analysis. Published data for this specific strain configuration are limited; exact numeric limits should therefore be taken from the licensed dossier.
Morphological identification supports molecular identity. Under a calibrated microscope with an ocular micrometer, E. acervulina oocysts are the smallest, E. maxima are the largest, and E. tenella and E. necatrix occupy intermediate size ranges. Because size ranges overlap between species, morphology alone is not sufficient for batch release. Species identity must be supported by molecular markers and, where available, by restriction fragment length polymorphism or sequencing of the 18S ribosomal RNA gene.
For liquid oocyst suspensions, pH and osmolality are controlled to prevent osmotic shock. A pH range of 6.0–7.5 and osmolality of 280–320 mOsm/kg are typical for oocyst storage buffers; values outside this range may accelerate sporozoite activation or oocyst wall damage. The buffer should be free of phosphate crystals because abrasion can rupture oocysts during mixing.
Commercial live anticoccidial vaccines are typically administered at doses in the range of 1 × 10² to 1 × 10³ sporulated oocysts per bird; the exact dose for this quadrivalent API must be fixed by the finished-product marketing authorization. Broiler chickens normally receive the vaccine during the first week of life via hatchery spray, gel droplet, or drinking water; replacement pullets and breeders may receive a second controlled exposure. For drinking-water application, the oocyst suspension is mixed in non-chlorinated water and delivered through a proportioner with dosing accuracy of ±5%. Free chlorine residual above 0.5 mg/L reduces sporozoite viability. Sodium thiosulfate at 0.25–0.50 g/L may be used as a neutralizer only after validation. Gel and spray systems should be calibrated with dye trials to ensure uniform deposition; a droplet size range of 150–250 µm and cabinet pressure of 2–3 bar are common for hatchery spray cabinets, but actual settings must be verified for each nozzle configuration. Once rehydrated, the working suspension should be used within 2–4 h unless stability data support longer; published data for this specific configuration are limited.
Water source quality affects oocyst viability beyond chlorine. Alkaline water above pH 8.5 or acidic water below pH 5.0 should be tested and adjusted; elevated iron, manganese, or copper levels require demineralization or use of a chelating agent because divalent metal ions accelerate oocyst wall damage. A gentle continuous agitation system with a low-shear impeller at approximately 50 rpm prevents sedimentation and ensures uniform oocyst suspension during drinking-water vaccination. Proportioner pumps with dead legs or air locks can create non-uniform dose distribution; flushing with dechlorinated water after each batch reduces cross-contamination.
For feed incorporation in premises or pelleted rations, standard steam conditioning is lethal to sporulated oocysts. Pellet mill conditioning at 70–80°C for 30–60 s generally destroys oocyst viability, so the API is applied after pelleting by vacuum coating or added as a post-cooling liquid spray. Powder and granule intermediates destined for premix use require a moisture content below 5% w/w for flowability, but overdrying below 2% w/w can damage the oocyst wall. The live API is incompatible with ionophore coccidiostats such as monensin, salinomycin, and narasin, and with synthetic compounds such as toltrazuril and decoquinate; concurrent use suppresses oocyst replication and cancels the vaccine response. Feed containing these additives should be withdrawn for at least 7 days before oral vaccination unless the manufacturer's data state otherwise. High-shear granulation and alcoholic granulation are not recommended because both can rupture oocyst walls; low-shear aqueous granulation with drying at 25–30°C under vacuum is the least damaging process route for a dry oral intermediate.
Vacuum coating equipment used on pelleted feed should be set to avoid air-jet atomization pressures above 1.5–2.0 bar at the spray nozzle, because high shear in the atomization zone can lyse oocysts. Post-pellet liquid application requires a negative-pressure mixing chamber with a residence time of 45–90 s and final pellet temperature below 35°C. Published data for this specific configuration are limited; these boundaries are derived from equipment behavior for live biological coatings and should be confirmed in pilot trials with viability counts.
The quadrivalent composition is not a single-antigen product. Each Eimeria species occupies a different region of the intestinal tract and produces a different prepatent period and oocyst output pattern. This determines the timing of flock monitoring after administration and the interpretation of gross lesion scores.
| Eimeria species | Principal intestinal site | Prepatent period (published range) | Typical post-vaccination lesion observation |
|---|---|---|---|
| E. acervulina | Duodenum and upper small intestine | 4–5 days | White transverse plaques; lesion score target below 2 |
| E. maxima | Midgut | 5–6 days | Petechiae, orange mucus, thickened mucosa |
| E. necatrix | Midgut, sexual stages in ceca | 6–7 days | Hemorrhagic small-intestine lesions; cecal floccular content |
| E. tenella | Cecal pouches | 6–7 days | Cecal hemorrhage, cecal cores, thickened cecal wall |
Lesion scoring for E. tenella and E. necatrix typically follows the 0–4 scale in challenge studies; a mean cecal lesion score below 2.0 at day 7 post-challenge is generally considered acceptable for vaccine efficacy, but published data for this specific configuration are limited. Oocyst output per gram of feces may rise between days 5 and 10 after vaccination; recycled oocysts in litter provide the controlled re-exposure needed for solid immunity.
The coexistence of E. tenella and E. necatrix in the same quadrivalent vaccine requires particular attention to cecal lesion scores because both species can produce cecal lesions at different stages. E. tenella causes cecal hemorrhage and cecal cores during day 5–7 post-infection, while E. necatrix sexual stages may appear in the ceca after day 6. Differential diagnosis should rely on both gross lesion site and oocyst morphology; E. tenella oocysts are broadly ovoid and larger than E. necatrix oocysts under calibrated microscopy. Litter moisture above 35% promotes massive oocyst sporulation and can amplify challenge re-exposure beyond the intended low-dose cycling, leading to clinical lesions. Ventilation and drinking-system management should maintain litter moisture below 30–35% in vaccinated houses.
The live quadrivalent API differs in route, mechanism, and operational risk from other classes of anticoccidial products.
| Product class | Route and active principle | Key operational constraint | Residue and withdrawal profile |
|---|---|---|---|
| Live quadrivalent oocyst API | Oral; sporulated oocysts of four Eimeria species | Heat, disinfectant, and ionophore sensitivity; oral route only for viable antigen | No chemical withdrawal; biological shedding managed by litter recycling |
| Live attenuated precocious vaccine | Oral; live precocious lines with shortened prepatent period | Heat sensitivity; reduced lesion score and oocyst output | No chemical withdrawal; lower environmental oocyst load |
| Ionophore or synthetic anticoccidial | Feed additive; continuous suppression of Eimeria replication | Drug resistance selection; homogenous feed mixing required | Specific withdrawal period before slaughter |
| Recombinant or subunit vaccine | Parenteral or in ovo; single protective antigen or antigen fragment | Narrow antigenic repertoire; adjuvant required | No chemical withdrawal; no oocyst shedding |
The core difference is that the live quadrivalent API generates endogenous recycling of oocysts in litter, which is both an immune booster and a management risk if litter moisture is not controlled. Unlike chemical controls, the live vaccine does not select for drug-resistant field strains, but it requires strict exclusion of anticoccidial residues from feed and water. Published data for the specific PTMZ/PNHZ/PMHY/PAHY master seeds are limited; cross-protection claims against heterologous Eimeria field isolates must be verified by challenge studies in floor pens with strain-specific PCR and oocyst output measurements.
The API should not be used in chickens receiving immunosuppressive doses of glucocorticoids or concurrent live bacterial vaccines by the same route unless compatibility is documented. The live vaccine can cause transient oocyst shedding; this is expected and not a sign of failure. However, in naïve flocks with high challenge pressure, clinical coccidiosis may occur if the initial dose is too high or if anticoccidial residues are inadvertently present. The manufacturer's recommended dose and withdrawal window for anticoccidial drugs should be followed exactly.
Safety testing for live anticoccidial vaccines generally includes overdose administration in target-age chickens, observation for clinical signs, and gross lesion scoring at defined intervals. Immunosuppression studies may be required if the vaccine is intended for simultaneous administration with other biologicals. The exact safety protocol is product-specific; harmonized requirements for live avian coccidiosis vaccines are described in relevant national and regional veterinary biological guidelines, but no single ISO standard applies to oocyst viability.
As a biological active substance intended for veterinary use, the API must be handled under EU GMP Annex 2 for biological active substances and relevant national veterinary biological licensing requirements. Store the concentrate at 2–8°C, protected from light, and do not freeze. Oocysts are highly resistant to common disinfectants, including quaternary ammonium compounds, phenolics, and 70% ethanol; validated inactivation requires dry heat above 80°C for 30 min, incineration, or a registered anticoccidial disinfectant validated for Eimeria. Spills should be contained immediately, absorbed with disposable material, and processed as biological waste. The product is not for human use and is restricted to chickens unless the marketing authorization specifically includes other avian species.
