Newcastle Disease Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Product Name: Newcastle Disease Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Factroy Site: Yudu County, Ganzhou, Jiangxi, China
- Price Inquiry: sales10@sinochem-nanjing.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
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- Newcastle Disease Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is typically used in formulations when antigenic potency and cold-chain storage parameters must be controlled within specific ranges.
| HS Code | 295392 |
| Product Name | Newcastle Disease Vaccine Veterinary Grade API |
| Api Type | Viral Antigen (Newcastle Disease Virus) |
| Virus Strain | LaSota / Mukteswar / Komarov depending on formulation |
| Target Species | Chickens, turkeys, and other domesticated birds |
| Dosage Forms Available | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Route Of Administration | Oral, Intranasal, Ocular, Subcutaneous, Intramuscular, or Spray depending on dosage form |
| Physical State | Lyophilized powder, solution, or granular solid as API grade |
| Solubility | Soluble in sterile water or physiological saline; reconstitution required for injection forms |
| Storage Conditions | Store at 2-8°C; protect from light; avoid freezing |
| Shelf Life | Typically 12 to 24 months from date of manufacture, depending on formulation |
| Ph Range | Stable at pH 6.5-7.5 in aqueous formulations |
| Potency Assay | Expressed as 50% egg infectious dose (EID50) or tissue culture infectious dose (TCID50) per dose |
| Adjuvants Present | Inactivated types may contain aluminum hydroxide or oil emulsion; live types usually no adjuvant |
| Preservatives | May contain thimerosal or antibiotics in multidose presentation if applicable as API with excipients |
| Packaging Type | Bulk API packaged in sterile sealed containers, vials, or laminated foil bags under inert atmosphere |
As an accredited Newcastle Disease Vaccine 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 in sealed, light-resistant containers with tamper-evident closures; available in 25 kg drums, suitable for veterinary pharmaceutical formulations. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with veterinary-grade Newcastle Disease Vaccine API, securely packaged for tablets, injections, capsules, powders, granules, premix, or solutions. |
| Shipping | Shipping: Newcastle Disease Vaccine Veterinary Grade API requires strict cold-chain transport at 2–8°C, protected from light, moisture, and freezing. Sterile, sealed, insulated containers with temperature loggers ensure stability. Expedited handling and gentle transit preserve potency until delivery. |
| Storage | Store at 2–8°C in a refrigerated, dry, and well-ventilated area. Keep in original airtight containers, protected from light, moisture, and heat. Do not freeze unless specified. Avoid repeated temperature fluctuations. Ensure strict cold-chain handling during transport and storage, and use immediately after reconstitution. Keep out of reach of children and animals. |
| Shelf Life | Shelf life: 24 months when stored at 2–8°C, protected from light, and not frozen, per stability data. |
Parenteral Newcastle disease antigen concentrates are formulated into killed-virus vaccines as the aqueous antigen component of a water-in-oil emulsion. The oil phase for a standard broiler-layer presentation is typically composed of light liquid paraffin at 45–50% v/v and sorbitan monooleate at 10–12% v/v. The aqueous antigen phase accounts for 35–40% v/v of the final emulsion and contains polysorbate 80 at 3.2–4.0% v/v in phosphate-buffered saline at pH 7.2–7.6. Prior to blending, the antigen concentrate is clarified through 0.45 µm cartridge filters and inactivated with beta-propiolactone at a dilution of 1:2000–1:4000 for 16–24 h at 4 °C, then verified by three serial passages in embryonated specific-pathogen-free eggs. The blend is homogenised in an inline high-shear rotor-stator mixer at 3500–5500 rpm until the mean droplet diameter reaches 1.0–3.0 µm. Larger droplets cause unacceptable local reactogenicity and smaller droplets may reduce antigen release at the injection site.
Potency is measured in chickens according to Ph. Eur. 0450 or 9 CFR 113.204. Release for the aqueous antigen component is typically set at not less than 50 PD50 per 0.5 mL dose after blending. Filling lines for oil emulsions run with positive-displacement piston pumps and in-line static mixers. Batch failure commonly arises from phase inversion when aqueous addition exceeds 42% v/v or when the sorbitan monooleate-to-polysorbate 80 ratio deviates from the required hydrophilic-lipophilic balance. The finished injectable emulsion is a white to off-white liquid supplied in 500 mL high-density polyethylene bottles. Terminal decontamination is not possible after emulsion formation, so aseptic assembly and bioburden control below 10 CFU/100 mL before inactivation are required. The product is used for subcutaneous or intramuscular vaccination of layers, breeders, and broilers, with booster administration at 3–4 weeks after primary vaccination.
What Drives Stabiliser Selection in Lyophilised Live Newcastle Disease Vaccine Powders?
For live virus lyophilisates, stabiliser performance is dictated by glass-transition temperature, cake structure, and residual moisture after freeze-drying. A representative formulation for a vial-based oculonasal and drinking-water vaccine contains sucrose 5–10% w/v, skimmed milk 2–4% w/v, hydrolysed gelatin 1–2% w/v, and potassium phosphate buffer at pH 7.0. The virus harvest is clarified through 0.2 µm disposable capsules, blended with the stabiliser at 2–8 °C, and filled into 2R type I glass vials at a nominal fill volume of 2.5 mL. Lyophilisation on a shelf freeze dryer uses a primary drying shelf temperature of −35 °C to −25 °C at chamber pressure 50–100 µbar for 24–36 h, followed by secondary drying at 20 °C for 6–8 h. The release specification for residual moisture is ≤2.0% w/w by Karl Fischer titration. Final container titre is not less than 10^6.0 EID50 per dose after reconstitution.
Sealed vials are back-filled with nitrogen to reduce oxidative damage. Collapse at the cake edge is a common lyophilisation failure when shelf temperature exceeds the collapse temperature of skimmed-milk-based matrices. Sublattice cracking across 20 mm vial freeze-drying fronts can produce titre variability of 0.3–0.7 log10 EID50 between top and bottom shelves. The dry plug is pink-white to off-white and is reconstituted with 3 mL sterile diluent for eye-nose drop administration or decanted into drinking water containing skimmed-milk stabiliser at 2 g/L. Drinking water must contain less than 0.5 mg/L free chlorine and remain below 25 °C during the 2 h administration window.
| Dosage format | Critical stabiliser or carrier | Typical inclusion range | Release criterion |
|---|---|---|---|
| Injectable emulsion aqueous phase | Polysorbate 80 in phosphate-buffered saline | 3.2–4.0% v/v | ≥50 PD50/0.5 mL |
| Lyophilised plug | Sucrose, skimmed milk, hydrolysed gelatin | 5–10% w/v, 2–4% w/v, 1–2% w/v | ≤2.0% w/w moisture |
| Fluid-bed granule | Trehalose, lactose monohydrate, skimmed milk | 4–8% w/w, q.s. to 100% w/w, 10–15% w/w | ≤3.0% w/w moisture |
| Feed top-dress premix | Defatted rice bran carrier, calcium carbonate, vegetable oil | 20–30% w/w, 30–40% w/w, 1–2% w/w | ≥10^6.0 EID50/20 g |
Enteric-Coated Tablet and Capsule Specifications for Oral Mucosal Priming
Solid oral Newcastle disease antigen formats are not the standard route in poultry. Where tablets or capsules are produced, they are niche presentations for controlled oral priming in parent stock and experimental waterfowl programmes. The process requires dry antigen powder with an infectivity titre loss during tableting of 0.8–1.5 log10 EID50 across compression forces from 5 kN to 12 kN on a 16-station rotary tablet press. A protective matrix contains mannitol 50–60% w/w, microcrystalline cellulose 20–30% w/w, croscarmellose sodium 3–5% w/w, and magnesium stearate 0.5–1.0% w/w. Capsule presentations use hydroxypropyl methylcellulose capsules filled by dosator nozzles to minimise shearing of antigen-coated granules.
Enteric coating is applied in a side-vented pan coater to a weight gain of 8–12% using methacrylic acid-ethyl acrylate copolymer dispersion. Dissolution is specified to begin above pH 5.5, protecting the virus from crop pH 3.5–4.5. Published data for this specific configuration is limited, and each batch requires titration before and after coating to map infectivity loss. Terminal product dimensions are typically 250 mg tablets or size 3 capsules containing a nominal antigen load of 10^6.0 EID50. These formats are not substitutes for mass spray or drinking-water vaccination in large flocks because individual oral administration is labour-intensive and crop retention time may be insufficient to achieve uniform mucosal exposure.
| Region or pharmacopoeia | Reference | Acceptance criterion |
|---|---|---|
| European Pharmacopoeia | Ph. Eur. 0450 | Identity, minimum infectivity titre per dose, extraneous agents |
| United States live virus | 9 CFR 113.205 | Live virus titre, safety, potency |
| United States killed virus | 9 CFR 113.204 | Killed virus potency by PD50 |
| International standard | WOAH Terrestrial Manual Chapter 2.3.14 | Vaccine batch release guidelines for Newcastle disease |
Live Newcastle disease virus powders intended for mass administration by drinking-water or intratracheal spray are formulated as fluid-bed granules rather than milled powder to reduce electrostatic segregation and improve flowability. The granulate consists of virus harvest blended with trehalose 4–8% w/w, skimmed milk 10–15% w/w, sodium glutamate 1–2% w/w, and lactose monohydrate as carrier to 100% w/w. Fluid-bed spray granulation operates with inlet air temperature 35–40 °C, product temperature 22–28 °C, and spray rate 5–8 g/min/kg bed mass. Outlet relative humidity is held below 20% RH. Granules are sieved to 150–500 µm for drinking-water sachets and 50–150 µm for coarse-spray dry powder. Final infectivity titre is adjusted to not less than 10^6.5 EID50 per dose in 1 mL aqueous solution and residual moisture is controlled at ≤3.0% w/w.
Batch failures in fluid-bed processing occur when wet-bridge formation increases agglomerate size above 800 µm, reducing the rate of dissolution in drinking water and creating uneven dose distribution in header tanks. Water quality during administration is critical; free chlorine must be below 0.5 mg/L, organic matter below 2 mg/L permanganate oxygen demand, and water temperature below 25 °C. The terminal product is packed in aluminium/polyethylene sachets under −0.4 to −0.6 bar vacuum in 500-dose, 1000-dose, and 5000-dose formats. The applied dose per bird is typically 10^6.0 EID50 in 10–20 mL drinking water within 2 h of mixing.
When Feed Premixes Are Top-Dressed After Pelleting
Newcastle disease virus premixes for feed administration are formulated as virus-coated carriers for top-dressing after pellet cooling because live virus loses infectivity rapidly at pelleting temperatures above 65 °C. The carrier matrix is defatted rice bran or soy hulls conditioned to 10–12% w/w moisture and coated in a low-shear drum mixer with virus-containing stabiliser and a binding agent at 2–4% v/w. A typical premix contains antigen-loaded carrier at 20–30% w/w, calcium carbonate 30–40% w/w, and vegetable oil 1–2% w/w as dust suppressant. The final inclusion rate is calibrated to provide 10^6.0 EID50 per 20 g bolus feed intake.
The premix is not suitable for mash feed that will be steam-conditioned because thermal exposure reduces titre by 0.5 log10 EID50 per 10 °C rise above 70 °C. Pellet top-dressing is performed after the pellets leave the cooler and drop below 35 °C. Mix time is kept below 5 min to minimise shear. Terminal packs are 20 kg multilayer paper bags with moisture vapour transmission rate below 2 g/m²/day. The application route is limited to controlled-floor-reared birds where individual drinking water access cannot be guaranteed.
Solution concentrates for hatchery coarse-spray and eye-drop application are prepared from clarified allantoic fluid that has been buffer-exchanged into stabiliser-containing diluent. The solution contains gelatin 2% w/v, sucrose 2–5% w/v, and phosphate-buffered saline at pH 7.2–7.4. The concentrate is compounded at 2–8 °C and passed through a 0.22 µm sterile filter before aseptic filling into 100 mL, 250 mL, and 500 mL low-density polyethylene dropper bottles. A final dose for coarse spray is 10^6.0 EID50 per bird in 0.2–0.3 mL delivered by a spray cabinet at a droplet size of 100–200 µm and a working pressure of 2–4 bar.
Solution stability after opening is the limiting operational parameter. The diluted vaccine must be used within 2 h when water temperature exceeds 20 °C. Prolonged exposure to sunlight or residual chlorine above 0.5 mg/L reduces infectivity by more than 1 log10 EID50 within 30 min. The liquid is colourless to pale yellow and must be kept at 2–8 °C during transport. Aseptic manufacture under EU GMP Annex 2 and environmental monitoring to ISO 14644-1 Class 8 for background and ISO 14644-1 Class 5 for the filling line is mandatory. The solution is used in hatchery day-old vaccination, with coarse-spray cabinets calibrated to deliver even cabinet coverage before chicks are placed into transport boxes.
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- Newcastle Disease Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is manufactured under an ISO 9001 quality system and complies with relevant regulatory requirements.
- COA, SDS/MSDS, and related certificates are available upon request. For certificate requests or inquiries, contact: sales10@sinochem-nanjing.com.
Newcastle Disease Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a bulk antigen concentrate prepared from a defined Newcastle disease virus seed of lentogenic or inactivated mesogenic lineage. The product type is not a finished field vaccine; it is an active pharmaceutical ingredient intended for further processing under current veterinary biological manufacturing licences. Manufacturer designations are lot-specific: NDV-VG-API-LY-100D represents the lyophilized bulk configuration calibrated to 100 dose equivalents after reconstitution, and NDV-VG-API-LIQ-50D represents the frozen liquid configuration. Standardization is performed by chicken embryo infectivity titration, reported as EID50 per dose equivalent; live lentogenic lots typically release at ≥ 106 EID50 per dose equivalent, while inactivated lots are characterized by pre-inactivation titre and antigen mass. Stabilizer systems consist of sucrose, mannitol, hydrolyzed gelatin, or sodium phosphate buffers; exact excipient ratios are disclosed on the certificate of analysis. The target species for finished dosage forms are domestic poultry, principally chickens and turkeys, against Newcastle disease caused by avian orthoavulavirus 1.
Which Compendial Tests Govern Release of NDV Antigen Concentrates Intended for Multiple Dosage Forms?
The release matrix is defined by the downstream route of administration and by the live or inactivated status of the antigen. For lyophilized live API, infectivity titre is the primary potency parameter; the titration is performed in 9- to 11-day-old specific-pathogen-free embryonated chicken eggs according to 9 CFR 113.37 or equivalent national monographs. Sterility is assessed by membrane filtration under Ph. Eur. 2.6.1 or USP <71>; absence of mycoplasma is confirmed under Ph. Eur. 2.6.7. Bacterial endotoxins are limited to ≤ 10 EU/mL for liquid API intended for injection, by Ph. Eur. 2.6.14 or USP <85>. Water content in lyophilized cake is controlled by Karl Fischer titration under Ph. Eur. 2.5.12; release limits are commonly ≤ 2.0% w/w. pH in reconstituted liquid is controlled between 6.5 and 7.5 under Ph. Eur. 2.2.3. For inactivated antigen, freedom from live virus is confirmed by serial passage in embryonated eggs under 9 CFR 113.36.
| Attribute | Method / Standard Designation | Control Limit |
|---|---|---|
| Residual water | Ph. Eur. 2.5.12 / USP <921> | ≤ 2.0% w/w |
| Sterility | Ph. Eur. 2.6.1 / USP <71> | No growth |
| Mycoplasma absence | Ph. Eur. 2.6.7 | No mycoplasma |
| Bacterial endotoxin, injectable grade | Ph. Eur. 2.6.14 / USP <85> | ≤ 10 EU/mL |
| Live virus titre | 9 CFR 113.37 embryo titration | ≥ 106 EID50 per dose equivalent |
| Inactivation completeness | 9 CFR 113.36 serial passage | No live virus |
| pH of reconstituted liquid | Ph. Eur. 2.2.3 | 6.5–7.5 |
| Lyophilized cake appearance | Visual inspection | Intact white to off-white cake |
Antigen propagation uses working seed lots from lentogenic strains B1, LaSota, or VG/GA for live products, or mesogenic strains such as Komarov or Roakin for inactivated products; specific strain identity is assigned by manufacturer. The virus is propagated in specific-pathogen-free embryonated chicken eggs at 37 °C and harvested from allantoic fluid after 72–96 h; cell culture adaptation on avian diploid cell lines is permitted where the master seed dossier supports equivalent antigenicity. Harvested allantoic fluid is clarified by continuous-flow centrifugation at 4 °C and filtered through membranes with nominal pore size 0.45 µm to 0.8 µm. The clarified antigen is stabilized before lyophilization; carbohydrate and protein stabilizers are added at 2–8% w/v. Inactivation, when required, is performed with beta-propiolactone or formalin at controlled temperature and time; residual inactivation agent must be below the applicable compendial or licensing limit.
Lyophilization of NDV-VG-API-LY-100D is performed on production freeze dryers with shelf surface areas from 5 m² to 20 m². The collapse temperature of sucrose-stabilized NDV formulations is typically between −28 °C and −34 °C; primary drying is therefore controlled at product temperature below −30 °C with chamber pressure 0.05–0.15 mbar. Secondary drying at +25 °C to +35 °C reduces residual water to ≤ 2.0%. Batch-to-batch heterogeneity in cake morphology is observed when the freezing ramp is not controlled; uncontrolled ice nucleation produces variable pore size, causing slow sublimation and occasional microcollapse at the vial bottom. Annealing at −15 °C to −20 °C for 90–180 min reduces this heterogeneity. The lyophilized API is then dry-milled under nitrogen and sieved through 250 µm mesh to produce the powder grade for tablets, capsules, and premix; milling is not applied to the liquid injection grade.
When a Single Production Lot Is Assigned to Oral Granules and Injectable Solutions
Assignment of one bulk lot to both oral and parenteral formats creates separate risk profiles that must be reconciled before release. Injectable solutions require sterility and bacterial endotoxin compliance; oral granules require aerobic microbial counts not exceeding 10³ CFU/g under Ph. Eur. 2.6.12 or USP <61>, and absence of Salmonella under Ph. Eur. 2.6.13 or USP <62>. The stabilizer system therefore cannot be selected solely for lyoprotection; it must also be dilutable in water for injection without exceeding endotoxin limits. Sodium chloride isotonic agents are used for injectable reconstitution, but the same salts may reduce oral powder flow and cause caking in unilaminate sachets if moisture ingress exceeds 0.5% during storage. Production scheduling in multi-product veterinary facilities usually segregates live NDV powder handling from sterile injectable filling by air-handling class and campaign timing to prevent cross-contamination; the API itself is not sterile after milling and must not be exposed to the injectable filling suite.
For solid oral dosage forms, the lyophilized powder is blended with excipients selected for low residual moisture and low reducing-sugar content. Mannitol, pregelatinized starch, microcrystalline cellulose, and sodium starch glycolate are used; lactose monohydrate may be used for premix but must be controlled for reducing sugar impurities because Maillard-reactive carbonyls can reduce antigen stability during storage at 25 °C and 60% RH. Direct compression of live NDV API is technically possible but limited by the fragile cake structure and low bulk density; published data on industrial tableting of live NDV antigen are limited. Dry granulation by slugging or roller compaction is preferred; roller-compacted granules are sieved to 710 µm and blended with extragranular disintegrant before compression. Compression forces above 150 MPa or tablet hardness above 15 kp may reduce virus titre by more than 0.5 log10 EID50; manufacturers validate titre recovery after compaction and adjust force accordingly. Capsule filling on dosator machines at ≤ 25 °C and ≤ 20% relative humidity prevents gelatin shell deformation and powder hydration. Powder and granule products for drinking water or feed premix are filled into foil-lined sachets or double polyethylene bags; oxygen scavengers are used because NDV is susceptible to oxidative damage of the viral envelope.
Injectable solutions are prepared by reconstituting the lyophilized API with sterile water for injection or phosphate-buffered saline pH 7.2; reconstitution time is typically less than 60 s when the lyophilized cake is formed with high-sublimation porosity. Liquid API intended for direct use in injectable solutions is filtered through 0.22 µm sterilizing-grade membranes only after antigen integrity is verified; live NDV particles are pleomorphic and may adsorb to membrane materials, so filter selection must be validated by haemagglutination titre before and after filtration. Solutions for eye-drop or spray administration are prepared as aqueous dilutions of the API; stabilizers such as hydrolyzed gelatin 1–3% w/v and sucrose 2–5% w/v protect against shear and desiccation. Solutions for drinking water use are buffered to 7.0–7.5 because municipal water chlorination and low pH degrade the virus; thiosulfate is added by the end user or by the formulator as a chlorine neutralizer.
Container closure for bulk API includes siliconized glass vials with bromobutyl stoppers for lyophilized cake, and polyethylene terephthalate bottles or foil-laminated pouches for powder and granule grades. Headspace oxygen is displaced with nitrogen during filling to < 5% residual oxygen; for frozen liquid, polycarbonate bottles are used at −20 °C. Extractables from elastomeric closures are monitored under USP <381> for injectable grades. The API is not irradiated and is not subjected to terminal steam sterilization; any sterility claim for the finished injectable solution is achieved by filtration or aseptic processing, not by terminal heat.
Key Differences from Adjuvanted Finished Vaccines and Recombinant Vector Antigens
Unlike finished adjuvanted NDV vaccines, the bulk API contains no mineral-oil emulsion, aluminium hydroxide, or squalene adjuvant; these adjuvants are added only during final formulation for injection and are incompatible with oral tablets, capsules, and dry premix. The API therefore allows downstream formulation into multiple dosage forms but requires the formulator to establish adjuvant compatibility separately for each finished product. In contrast to recombinant vector vaccines, the NDV-VG-API line is not propagated as a vector chimera; it is a full-virus antigen derived from specified-pathogen-free embryonated chicken eggs or avian cell culture. Residual host-cell DNA and egg protein must be declared for every lot intended for injection; the acceptance limits are set by the licensing authority and are not harmonized across all pharmacopoeias. Compared with live bacterial vaccine APIs, NDV replication in mammals is inefficient, requires low-temperature storage at 2–8 °C for liquid and ≤ −15 °C for frozen configurations, and is inactivated by lipid solvents, detergents, acidic pH below 4, and temperatures above 56 °C for 30 min. This limits its use in feed processing steps that involve pelleted feed at die temperatures above 70 °C.
Operational boundaries for handling NDV-VG-API-LY-100D include controlled room temperature for short-term milling only; prolonged exposure above 25 °C or relative humidity above 20% during powder processing is not recommended. The API is incompatible with cationic surfactants, quaternary ammonium disinfectants, oxidizing agents, and amine-containing buffers that can disrupt the viral envelope. Mixing with acidified carriers or effervescent tablet components containing citric acid is contraindicated unless the virus is protected by enteric or lipid coating. For injectable solutions, no preservative should be added to live NDV antigen without preservative effectiveness testing under USP <51>, because thiomersal and benzalkonium chloride reduce live titre at concentrations above 0.01% w/v. Granules and premix should be stored in sealed packaging at 2–8 °C and used within the validated shelf life stated on the label; published data for long-term stability of tableted live NDV API are limited.
