| HS Code | 115855 |
| Product Name | Combined Newcastle Disease and Infectious Bronchitis Vaccine, Live (Strain La Sota or HB1 + Strain H120) Veterinary Grade API |
| Target Diseases | Newcastle disease and infectious bronchitis |
| Vaccine Type | Live attenuated combined vaccine |
| Virus Strains | Newcastle disease virus strains La Sota or HB1; infectious bronchitis virus strain H120 |
| Target Species | Chickens and other susceptible poultry |
| Immune Response | Induces both humoral and local mucosal immunity against Newcastle disease and infectious bronchitis viruses |
| Route Of Administration | Intranasal, intraocular, drinking water, coarse spray, or injection depending on final formulation |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Shelf Life | Typically 12 to 24 months from date of manufacture depending on final formulation and storage |
| Bioactivity Titer | Contains defined virus titers, typically at least 10^6 EID50 per dose for Newcastle disease component and at least 10^4 EID50 per dose for infectious bronchitis component |
| Adjuvant Content | None for the live vaccine API; adjuvants may be added separately in final formulations |
| Preservative Status | Typically free of preservatives due to live viral nature; stabilizers may be present |
| Withdrawal Period | Zero days for poultry meat and eggs when used according to label directions |
As an accredited Combined Newcastle Disease and Infectious Bronchitis Vaccine,Live (Strain La Sota or HB1+Strain H120) 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 | Sealed sterile vials containing live combined Newcastle Disease (La Sota/HB1) and Infectious Bronchitis (H120) vaccine, veterinary grade. Quantity: 100 doses/vial. |
| Container Loading (20′ FCL) | One 20-foot container holds temperature-controlled, export-grade cartons of live combined Newcastle Disease and Infectious Bronchitis vaccine (La Sota/HB1 + H120), veterinary API. |
| Shipping | Ship as live biological material, UN 3373 Category B if applicable, with strict temperature control at 2–8°C. Use validated insulated packaging, leak-proof sealed vials, absorbent material, and rigid outer carton. Protect from light, avoid freezing. Label clearly, include safety data sheet, and comply with IATA/IMDG/ADR transport regulations for veterinary vaccines. |
| Storage | Store at 2–8°C (refrigerate, do not freeze) and protect from light. Keep in sealed, moisture-proof containers away from direct sunlight and heat. Use immediately upon reconstitution; discard unused contents. Maintain cold chain during transport and handling to preserve vaccine potency and efficacy for veterinary formulations. |
| Shelf Life | Shelf life is typically 18–24 months when stored at 2–8°C, protected from light, and not frozen. |
Downstream poultry-vaccine manufacturers reconstitute the lyophilised combined matrix in cooled diluent at 2–8 °C to a final concentration delivering 1,000 doses per 500 mL or 1,000 mL, depending on cabinet calibration. The La Sota component is selected when field Newcastle challenge risk justifies higher immunogenicity, whereas HB1 is selected where minimising post-vaccinal respiratory reaction in day-old broiler lines is prioritised; H120 remains the infectious bronchitis component in both strain pairings. Formulation addition is based on virus titre rather than mass percentage: each single bird dose contains not less than 105.5 EID50 of ND virus and 103.5 EID50 of IB H120 virus in a calibration volume of 0.15–0.25 mL per chick. The downstream process comprises aseptic reconstitution, transfer to a stainless-steel spray cabinet, and delivery through a rotary atomiser or binary nozzle array calibrated to a mass median droplet size of 120–180 µm. Droplet-size distribution is measured at line start and after lane changes by laser diffraction according to ISO 13320:2020; droplets below 100 µm are associated with deep-lung deposition and increased post-vaccinal rales, while droplets above 220 µm reduce coverage uniformity in high-density chick boxes. Lyophilisation of the bulk API into the final cake format uses an annealing step at −20 °C, primary drying shelf temperature between −30 °C and −25 °C, and secondary drying at +25 °C until residual moisture by Karl Fischer titration is ≤2.0 %. Potency, virus content, safety, and freedom from extraneous agents are evaluated under Ph. Eur. monograph 0450 for live Newcastle disease vaccine and monograph 0442 for live avian infectious bronchitis vaccine, within the GMP framework of EU GMP Annex 2 for biological active substances. The terminal dosage form is a 2,500-dose or 5,000-dose Type I glass vial with bromobutyl stopper, presented as freeze-dried cake for suspension for hatchery cabinet spray, stored at 2–8 °C, and used within 2 h after reconstitution.
Effervescent tablet presentation for drinking-water vaccination requires a dry, free-flowing granulate in which the live virus is embedded in a hygroscopic protective matrix. The formulation contains an effervescent couple of sodium bicarbonate and citric acid at 20–28 % w/w, a carbohydrate stabiliser system of sucrose or trehalose at 6–10 % w/w, hydrolysed gelatin at 0.5–1.5 % w/w, and directly compressible sorbitol or lactose monohydrate as filler. Because live La Sota or HB1 and H120 particles are thermolabile and shear-sensitive, blending is performed at 15–20 °C and ≤20 % relative humidity, with total blend time not exceeding 20 min. Rotary tablet compression is limited to a main compression force of 5–8 kN; higher forces increase tablet hardness but produce measurable viral titer loss. Published tablet-compression data for this exact ND/IB live virus matrix are limited, so compression overage and force limits must be confirmed through manufacturer-specific process validation. The tablet is formulated to deliver 1,000 doses per 3.0 g tablet, and disintegration time in 15–20 °C water is below 3 min when tested in accordance with Ph. Eur. 2.9.1. Drinking-water application requires neutralisation of chlorine and chloramine residues before tablet addition; skimmed milk powder at 0.25 % w/v or sodium thiosulfate is used to prevent oxidative inactivation. Final dose administration follows age-specific water consumption, typically 10–20 mL per bird over a 2 h drinking period. Release retention after tablet disintegration remains ≥105.5 EID50 ND and ≥103.5 EID50 IB H120 per dose. Demonstration of compliance requires Ph. Eur. 0450 and 0442, EU GMP Part I for solid dosage form manufacture, and EU Regulation 2019/6 for veterinary medicinal product authorisation. The terminal product is an aluminium/Aclar/PVC blister containing 1,000-dose effervescent tablets for oral suspension, packed in sealed aluminium pouches with desiccant and stored at 2–8 °C.
When the combined live API is routed into an inactivated injectable line, the downstream process differs fundamentally from lyophilised oral or spray presentations. The live La Sota or HB1 and H120 working seed is inoculated into 9–11-day-old embryonated chicken eggs via the allantoic cavity at 102.0–103.0 EID50 per egg. After 48–72 h incubation, allantoic fluid is harvested and clarified by continuous centrifugation at 4 °C, and the clarified live viral suspension is inactivated with formalin at 0.1 % v/v for 24 h at 37 °C. Inactivation is verified by passage of representative samples in embryonated eggs; no live virus may be detected after three blind passages. The inactivated aqueous antigen phase is emulsified into mineral oil and mannide oleate emulsifier at an aqueous-to-oil ratio of 30:70 to 40:60 v/v, using a rotor-stator unit operating at 5,000–8,000 rpm at 60–70 °C, with mean droplet diameter held below 1 µm as measured by laser diffraction. The final injection volume is 0.5 mL per bird by subcutaneous or intramuscular route, used for breeder and layer booster programmes where prolonged antibody transfer to progeny is required. Potency and safety are assessed against Ph. Eur. monograph 0870 for inactivated Newcastle disease vaccine and monograph 0959 for inactivated avian infectious bronchitis vaccine, with inactivation kinetics and extraneous agent freedom managed under Ph. Eur. 0062. The terminal product is a 500 mL HDPE bottle or 100 mL PET vial of white oil-emulsion injection, stored at 2–8 °C and warmed to 25 °C before injection to reduce viscosity and injection-site reactions.
For oculo-nasal vaccination of replacement pullets and breeder chicks, the lyophilised cake is designed with higher porosity to reconstitute rapidly in 25 mL diluent per 1,000 doses, producing a clear-to-slightly opalescent suspension for multiple-dose dropper use. The individual dose volume is 0.03 mL per eye or nostril. Release titre is set at ≥105.8 EID50 per dose for ND and ≥103.8 EID50 per dose for IB H120, reflecting that individual administration cannot tolerate the titer losses accepted in mass water or spray routes. Freeze-dried cake architecture is controlled through ice nucleation at −5 °C and annealing at −20 °C for 2 h; primary drying shelf temperature is held between −32 °C and −28 °C to prevent collapse, because the collapse temperature of the sucrose-gelatin matrix is approximately −31 °C. Secondary drying at +25 °C continues until residual moisture is ≤1.5 % by Ph. Eur. 2.5.12. The terminal format is a 25 mL Type I glass dropper vial with a low-density polyethylene dropper tip, containing lyophilised cake for oculo-nasal suspension, stored at 2–8 °C and used within 4 h after reconstitution. In-use stability at 25 °C over 4 h is a critical process validation end point because viral titer decay and bacterial contamination risk are both faster in multi-dose oculo-nasal droppers than in single-use hatchery spray devices. Regulatory acceptance of this presentation is evaluated under Ph. Eur. 0450 and 0442, with extraneous agent and stability obligations under Ph. Eur. 0062.
In farm-level water proportioner systems, the lyophilised API is converted into a 1,000-dose foil sachet powder or granule for oral suspension rather than a compressed tablet. The dry premix format is prepared by blending lyophilised API with lactose monohydrate, sucrose, and stabiliser in a low-shear tumbler at 15–20 °C and ≤30 % relative humidity, followed by filling into triple-layer aluminium sachets under nitrogen to maintain headspace oxygen below 0.5 %. Sachet fill weight is calibrated to 20 g per 1,000 doses, with active virus overage set at 0.3–0.5 log10 EID50 per dose above release titre to cover dry-blend shear and reconstitution losses. At the farm, one sachet is dissolved in 10 L of cool non-chlorinated water, corresponding to 10 mL per bird for a 1,000-bird house, and supplied through a dosing pump set to deliver medicated water over 2 h. If free chlorine exceeds 0.1 mg/L, water is treated with sodium thiosulfate at 2–4 mg/L or skimmed milk powder at 0.25 % w/v before sachet addition. The terminal product is a 1,000-dose aluminium foil sachet of powder/granules for oral suspension, stored at 2–8 °C, with an in-use shelf life of 2 h after reconstitution in drinking water at an ambient temperature not exceeding 25 °C. Regulatory acceptance of the sachet format is evaluated under Ph. Eur. 0450 and 0442 for live vaccine monographs, Ph. Eur. 0062 for extraneous agent freedom, and EU GMP Part I for solid dosage packaging.
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The active pharmaceutical ingredient is a combined live avian vaccine concentrate designated NDV-API-LS-H120 when the Newcastle disease fraction is strain La Sota and NDV-API-HB1-H120 when strain HB1 is used. The infectious bronchitis fraction is strain H120. The material is supplied as lyophilized, embryo-propagated antigen for formulation into tablets, injections, capsules, powders, granules, premix, and solutions. Each batch is standardized by virus titration in specific-pathogen-free embryonated chicken eggs; the release titer is not less than 106.0 EID50 for the Newcastle disease virus fraction and not less than 103.5 EID50 for the infectious bronchitis virus fraction per target dose. Residual moisture is controlled to ≤ 2.5% w/w. The lyophilized powder is stabilized with a sucrose-phosphate-glutamate or hydrolyzed gelatin matrix. Storage is 2–8 °C for final drug product or −20 °C for bulk antigen depending on the assigned shelf life. The target dose must be fixed by the downstream marketing authorization holder because it changes with host species, route, and age.
The product is differentiated from monovalent live Newcastle disease or infectious bronchitis vaccines by the presence of both viral fractions in one lyophilisate. It is differentiated from inactivated ND+IB preparations by the absence of mineral oil adjuvants and by the requirement for strict cold-chain handling to maintain live virus integrity.
The lyophilized material is not a ready-to-administer finished product. Downstream processors may blend it into powders, granules, or premixes; fill it into capsules; compress it into tablets; reconstitute it into solutions; or package it as injection-grade lyophilisate. The choice among these forms introduces different process risks. Tablets and capsules expose the live viruses to compression shear and excipient water activity. Injections require sterile reconstitution and non-inactivating tonicity agents. Powders, granules, and premixes require low-temperature drying and protection from ambient humidity. Solutions require stabilizers such as 0.1% w/v skimmed milk powder or buffered sodium thiosulfate.
For seed lot production, the master seed viruses are propagated in 9–11-day specific-pathogen-free embryonated chicken eggs. La Sota and HB1 are classified as lentogenic Newcastle disease virus strains; H120 belongs to the Massachusetts serotype of infectious bronchitis virus. The allantoic fluids are harvested, clarified by centrifugation, blended, and lyophilized. Virus titration is performed by allantoic cavity inoculation of diluted rehydrate into SPF eggs and the titer is calculated by the Spearman-Kärber or Reed-Muench method. Identity is confirmed by RT-PCR targeting the Newcastle disease virus F gene and the infectious bronchitis virus S1 gene.
The freeze-drying cycle is designed to keep the product temperature below the collapse temperature. Freezing is carried out at a shelf temperature below −40 °C, and secondary drying is performed at a shelf temperature not exceeding 25 °C. Chamber pressure is typically maintained between 0.1 mbar and 0.3 mbar. Sucrose-phosphate-glutamate is preferred because it forms an amorphous glass with low molecular mobility around the virus particle. Hydrolyzed gelatin provides lyoprotection but may introduce batch-to-batch variability. The finished lyophilisate is a porous cake with residual moisture ≤ 2.5% w/w; collapse or shrinkage of the cake is cause for rejection because it indicates lyophilization failure.
On production-scale lyophilizers, the main bottleneck is the thermal mass of the shelves and the frozen cake. The cycle time can exceed 48 h because primary drying must remove water without exceeding the collapse temperature of the sucrose-phosphate-glutamate matrix. Loading density should be uniform across shelves; edge vials may dry faster and show lower residual moisture, while center vials may retain moisture above the release limit if shelf heat transfer is uneven. Differential scanning calorimetry is used to confirm the glass transition temperature of the maximally freeze-concentrated solution before scale-up. A collapse temperature below −30 °C requires a conservative primary drying ramp. Batch-to-batch variance in virus titer is controlled by using qualified SPF egg lots and in-process titration before lyophilization. Sterility assurance is achieved by aseptic processing rather than sterilizing-grade filtration because virus particles exceed 0.22 µm membrane pore size. Cleanroom operations are classified according to ISO 14644-1, with the lyophilization loading zone controlled to the class specified in the downstream marketing authorization.
Direct compression of the lyophilized API into tablet and capsule presentations requires dry blending with mannitol-based excipients at ≤ 30% RH and ≤ 25 °C. A rotary tablet press with prechilled tooling is preferred because tablet punches and dies can retain heat during extended campaigns. Compression force is set as low as possible while maintaining a tablet hardness of at least 2 kp; titer retention after compression must be demonstrated for each formulation. Published data for this specific configuration is limited, so downstream formulators should verify virus titration after compression using the same SPF egg titration method used for bulk release. Capsule filling should be performed under nitrogen purge where feasible, especially when the capsule shell has a moisture content above 3% w/w.
For powder, granule, and premix processing, fluid-bed granulation is preferred over high-shear wet granulation because water activity above 0.3 can reduce live virus infectivity. Inlet air to the fluid bed is maintained at ≤ 30 °C with a dew point of ≤ −10 °C. Pre-drying of excipients is required when ambient relative humidity exceeds 60%. For injection-grade solutions, the lyophilisate is reconstituted in sterile water for injection without bacteriostatic preservatives because preservatives may inactivate the live viruses. The pH after reconstitution should remain between 6.5 and 7.5, and tonicity agents should be limited to those with documented non-inactivating properties. Wet granulation and spray-drying are generally avoided because heat and shear can reduce live virus titer; the exact titer loss must be established for each formulation before routine production.
In target-species safety studies, a 10× overdose of the recommended dose should be administered by each intended route. Post-vaccinal respiratory signs, if present, should be transient and should not exceed 7 days in broilers. Persistent signs require investigation of bacterial contamination, reversion to virulence, or inappropriate stabilizer composition. In laying birds, the live API should be handled as a potential induction factor for transient egg production drops, so vaccination is usually scheduled before onset of lay or after peak production based on veterinary risk assessment.
Maternal antibody interference is the main determinant in choosing between La Sota and HB1. La Sota replicates more vigorously at respiratory mucosal surfaces and often gives a stronger immune response in high-maternal-antibody broiler flocks, but it can produce transient post-vaccinal respiratory signs. HB1 is selected when the flock has low maternal antibody or when the production system cannot tolerate additional respiratory stress. H120 is a mild Massachusetts-type infectious bronchitis strain used as a primer; it is frequently combined with later booster strains such as 4/91 or CR88 in multi-age layer operations. The final strain combination is chosen by the flock veterinarian after serological profiling.
Compared with monovalent live vaccines, the combined product reduces bird handling but requires verification that the two viruses do not interfere in the target population. Published data for the exact titer compensation required in field flocks is limited. Compared with inactivated ND+IB vaccines, this live API induces mucosal IgA and local cell-mediated immunity earlier, but the circulating antibody response is lower and less durable without a killed booster. The absence of oil emulsion also removes injection-site reactogenicity but eliminates the depot effect. Compared with recombinant viral vector vaccines, the product is generally not used for in ovo vaccination because the vaccine viruses replicate in the embryo and may reduce hatchability.
The strain-level performance boundaries are summarized below.
| Parameter | La Sota | HB1 | H120 |
|---|---|---|---|
| Virus type | Lentogenic Newcastle disease virus | Lentogenic Newcastle disease virus | Massachusetts infectious bronchitis virus |
| Mucosal replication | Higher | Moderate | Moderate |
| Post-vaccinal respiratory reaction | More pronounced | Milder | Mild |
| Maternal antibody breakthrough | Higher breakthrough capacity | Narrower | Vaccination timing-dependent |
| Primary application | High-challenge broilers and pullets | Respiratory-stress-sensitive broilers | Combined IB primer |
For drinking-water delivery, the API is dissolved in chlorine-neutralized water; free residual chlorine is kept below 0.1 ppm and water temperature at ≤ 22 °C. A stabilizer such as 0.1% w/v skimmed milk powder or sodium thiosulfate is sometimes added. Water lines should be free of disinfectants, detergents, and heavy-metal ions. The vaccination volume should be consumed within 2 hours to minimize loss of infectivity. Water may be withheld for 1–2 hours before vaccination to improve uniformity of intake, but this practice must be adjusted for ambient temperature to avoid dehydration.
For coarse spray administration, a droplet size of 100–150 µm is typical for day-old chicks; the downstream nozzle type and vaccine volume determine the final particle size distribution. For eye-drop administration, the API is reconstituted to deliver one target dose in 0.03–0.05 mL. Tablet and capsule presentations are not routine in avian veterinary medicine; if they are developed, the oral route must be validated for antigen delivery to gut-associated lymphoid tissue and for protection against gastric acid inactivation. Solutions for drinking water or spray should not be mixed with other live vaccines unless compatibility data are available.
Release testing of the bulk lot is required before any downstream formulation step. Sterility is verified by the Ph. Eur. 2.6.1 method, and mycoplasma absence by Ph. Eur. 2.6.7. Extraneous virus testing follows 9 CFR § 113.37 using embryonated egg inoculation and cell culture. Identity and potency are confirmed by RT-PCR and SPF egg titration. The release matrix is summarized below.
| Control | Acceptance criterion | Method/reference |
|---|---|---|
| Newcastle disease virus potency | ≥ 106.0 EID50 per target dose | Allantoic cavity titration in 9–11-day SPF embryonated eggs; Spearman-Kärber calculation |
| Infectious bronchitis virus potency | ≥ 103.5 EID50 per target dose | Allantoic cavity titration with IBV-specific antiserum; Spearman-Kärber calculation |
| Residual moisture | ≤ 2.5% w/w | Karl Fischer coulometric method; USP 921 |
| Sterility | No growth | Ph. Eur. 2.6.1 |
| Mycoplasma | Negative | Ph. Eur. 2.6.7 |
| Extraneous viruses | Negative | 9 CFR § 113.37 |
| Identity | La Sota or HB1 plus H120 | RT-PCR targeting NDV F gene and IBV S1 gene |
The release titer should be verified after each downstream unit operation, not only at bulk release, because drying, compression, and dissolution can reduce infectivity. Stability testing at 2–8 °C should include virus titration at 0, 3, 6, 12, 18, and 24 months for the final dosage form; bulk antigen stored at −20 °C may be retested before use. If the final dosage form is injectable, bacterial endotoxin testing should be added because live virus titration does not measure endotoxin.
