| HS Code | 832116 |
| Product Name | Pseudorabies Vaccine, Inactivated Veterinary Grade API |
| Product Type | Inactivated vaccine (killed virus) |
| Active Ingredient | Inactivated Pseudorabies virus (Suid herpesvirus 1) |
| Target Species | Swine (pigs) |
| Indication | Active immunization against pseudorabies (Aujeszky's disease) |
| Route Of Administration | Intramuscular injection |
| Dosage Forms Available | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Adjuvant | May contain aluminum hydroxide or oil emulsion as immunopotentiator |
| Storage Conditions | Store at 2-8°C and protect from light |
| Shelf Life | Typically 12 to 24 months depending on formulation |
| Immunological Effect | Induces humoral and cell-mediated immunity against pseudorabies virus |
| Safety Profile | Non-reverting to virulence due to complete inactivation |
| Veterinary Classification | For veterinary use only |
| Packaging Type | Sealed sterile vials, sachets, or bulk containers as API grade material |
| Withdrawal Period | As per veterinary label; generally zero days for swine |
As an accredited Pseudorabies Vaccine,Inactivated 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 | Each sealed container holds 100g of inactivated Pseudorabies Vaccine veterinary-grade API, supplied as sterile powder for formulation into various dosage forms. |
| Container Loading (20′ FCL) | 20′ FCL: palletized, temperature-controlled loading of Pseudorabies Vaccine inactivated veterinary API, secured, labeled, with cold-chain integrity maintained throughout. |
| Shipping | Ship as "Inactivated Pseudorabies Vaccine, Veterinary Grade API." Transport under strict temperature control (2–8°C), in validated insulated packaging with refrigerants. Use approved biological substance shippers, clearly labelled for veterinary use only. Documentation must include MSDS, export/import permits, and cold-chain monitoring logs to ensure stability and regulatory compliance. |
| Storage | Store Pseudorabies Vaccine (Inactivated) Veterinary Grade API at 2–8°C in a refrigerated environment. Protect from light, moisture, and freezing. Keep containers tightly sealed in original packaging in a dry, well-ventilated area. Avoid temperature fluctuations; do not use beyond expiry. Handle with care to maintain sterility and product integrity. |
| Shelf Life | Shelf life: typically 24 months when stored at 2–8°C, protected from light, and not frozen. |
Inactivated SuHV-1 antigen suspensions intended for intramuscular vaccination of replacement gilts and boars are commonly adsorbed onto aluminium hydroxide gel under low-shear agitation in jacketed stainless-steel vessels. The inactivated viral harvest is typically produced from PK-15 or VERO cell culture and inactivated with binary ethylenimine; residual BEI is neutralised with sodium thiosulfate before downstream blending. Adsorption is carried out at 2–8 °C for 16–24 h, with residual protein monitored by bicinchoninic acid assay; adsorption efficiency above 85% is required to avoid free antigen loss during shipping and injection-site dilution. Phosphate-buffered saline is limited to ≤10 mM because higher phosphate displaces surface hydroxyl groups and promotes gel aggregation. Final formulated bulk is adjusted to pH 7.0–7.4 and osmolality 280–320 mOsm/kg. Sterility testing follows Ph. Eur. 2.6.1 or 21 CFR 610.12; because the aluminium-containing adjuvant cannot be terminal-filtered, aseptic processing in an ISO 7 filling suite with periodic media-fill verification is mandatory. Production-scale failure modes include settling of aluminium flocs when a bottom-mounted impeller operates below 30 rpm, and premature gel aggregation when antigen concentrate is charged too rapidly into the adjuvant tank. The fill line typically uses peristaltic pumps with disposable tubing sets and in-line check-weighing every 15 min. Potency is confirmed by the rabbit serology test described in 9 CFR 113.101, and endotoxin is controlled by Ph. Eur. 2.6.14 with a finish-product limit not exceeding 20 EU/mL.
The lyophilization cycle for inactivated SuHV-1 antigen cake is constrained by the collapse temperature of the formulation, which is measured by freeze-drying microscopy and sub-ambient differential scanning calorimetry before full-scale freeze-drying. Formulations containing trehalose and mannitol in the range 4–8% w/v commonly exhibit collapse temperatures between -32 °C and -25 °C. Primary drying is therefore executed at shelf temperatures of -30 °C and chamber pressures of 0.10–0.20 mbar; at product temperatures above the collapse threshold, the cake forms a collapsed, high-residual-moisture matrix that cannot be reconstituted within 90 s. The lyophilizer is equipped with a stoppering system, Pirani/capacitance manometer comparison for product temperature monitoring, and type T thermocouples placed in edge and centre vials. Edge vials typically dry 20–40% faster than centre vials because vial heat transfer coefficients vary from 0.5 to 2.0 W/m²K across the shelf. Secondary drying is performed at 25 °C for 6–10 h, and residual moisture is determined by Karl Fischer titration according to Ph. Eur. 2.5.12 with a release limit of ≤3.0%. Reconstitution is performed with water for injection at 20–25 °C, and the resulting injectable solution is used immediately because the unprotected liquid form can lose antigen titre after 8 h at room temperature.
During multivalent vaccine manufacture, an antigen premix containing inactivated SuHV-1, porcine parvovirus, and Erysipelothrix rhusiopathiae fractions is blended in a single-use mixing system before final dilution and filling. The premix vessel is held at 4–8 °C under a nitrogen overlay to reduce oxidative damage to oil adjuvants and viral glycoproteins. Compatibility screening includes zeta potential measurement and visual flocculation scoring at 0 h, 24 h, and 72 h. pH drift greater than 0.20 units indicates buffering incompatibility and requires reformulation of the phosphate or histidine buffer. Finished multivalent premix is held for ≤72 h before filling to limit antigen degradation; in-line static mixers are preferred because shear rates remain below 500 s⁻¹, whereas rotor-stator recirculation can introduce 1.5–3.0 °C heat per pass and destabilise the emulsion. The premix is not a feed additive; it is a final bulk intermediate prepared under cGMP and released according to the matrix below before transfer to the filling suite.
| Intermediate/Route | Analytical Control | Release Limit | Reference Method |
|---|---|---|---|
| Aqueous aluminium-adjuvanted injectable | Adsorption efficiency | ≥85% | BCA total protein balance |
| Oil-in-water emulsion injection | Droplet size D90 | ≤5 µm | ISO 13320:2020 laser diffraction |
| Lyophilized powder | Residual moisture | ≤3.0% | Ph. Eur. 2.5.12 Karl Fischer |
| Multivalent premix intermediate | pH drift at 4 °C over 72 h | ≤0.20 units | Ph. Eur. 2.2.3 pH meter |
Water-in-oil and oil-in-water adjuvanted formulations for pre-farrowing sow boosters require controlled high-shear dispersion to maintain emulsion droplet size distribution during 24-month storage at 2–8 °C. The primary emulsion is produced in a rotor–stator mixer operating at tip speeds of 18–25 m/s, followed by a high-pressure homogenizer at 500–1000 bar where a narrower droplet span is required. The oil phase typically contains light liquid paraffin and mannide oleate; the aqueous phase contains SuHV-1 antigen, polysorbate 80, and phosphate buffer. Droplet size is measured by laser diffraction according to ISO 13320:2020, with intramuscular acceptance of D50 ≤2 µm and D90 ≤5 µm. Viscosity measured with a Brookfield LV spindle 63 at 12 rpm remains between 40 and 120 mPa·s at 20 °C. Accelerated stability at 37 °C for 7 days must not show phase separation or a D90 shift greater than 10%. Production-scale batch variance is often introduced by differences in antigen concentrate ionic strength; if the aqueous phase conductivity exceeds 15 mS/cm, emulsion inversion occurs and the batch fails droplet-size release. Injection-site reactivity is higher for droplets above 10 µm, so release testing removes those batches. Potency and safety tests follow 9 CFR 113.101 and Ph. Eur. 0744, with the final product held under continuous cooling until filling.
Tablet and capsule presentations for inactivated SuHV-1 antigen are not supported by current veterinary immunology data and are not described in 9 CFR 113.101 or Ph. Eur. 0744 for Aujeszky’s disease vaccine. Dry compaction of antigen powders on a rotary tablet press with compression pressure above 100 MPa or roll compaction pressure above 4 kN/cm generates local heat and mechanical shear that denature immunogenic glycoproteins. Even with trehalose or dextran cryoprotectants, antigen titre loss of 1–2 log₁₀ remains a practical risk. Hard-gelatin capsule filling does not provide the aqueous pH and antioxidant environment required for viral glycoprotein stability. If an oral capsule or tablet is pursued for experimental mucosal delivery, the antigen granulate is typically processed by low-shear extrusion at product temperature below 30 °C and then enteric-coated in a fluid-bed coater with Eudragit L 30 D-55 at inlet air temperature 45–55 °C and product temperature 28–32 °C. Published data for this specific configuration is limited. Because terminal compression is destructive, release specifications must include rehydrated antigen recovery by ELISA or virus neutralization relative to pre-compression bulk, with acceptance not less than 70% of original titre. Until such data are submitted to the competent veterinary biologics authority, tablet and capsule routes should be excluded from label claims.
For oral granule and solution development, the stability limitations of inactivated SuHV-1 antigen are dominated by pH-dependent envelope glycoprotein denaturation. In the fasting pig, gastric pH can fall below 3.0, and SuHV-1 envelope glycoproteins are denatured at pH below 4.5. Enteric-coated granules prepared by extrusion-spheronization require spheronization speeds of 400–800 rpm and spheronization plate temperatures below 28 °C to preserve titre. The coating process in a bottom-spray fluid-bed coater uses a hydroxypropyl methylcellulose acetate succinate dispersion at 10–15% solids, with product temperature maintained at 29–31 °C. Even with successful enteric protection, M-cell uptake of inactivated pseudorabies antigen in the ileal Peyer’s patches is insufficient to generate a reliable protective immunoglobulin A response without live replication; published efficacy data for this route are limited. Liquid solutions for intranasal or oral administration should not be stored for more than 24 h after reconstitution because antigen degradation in chlorinated drinking water occurs rapidly when free chlorine exceeds 0.5 mg/L. For drinking-water delivery, a chlorine-neutralising agent such as sodium thiosulfate at 0.1–0.2 g/L is required before antigen addition, and the final solution must be administered within 4 h to avoid titre loss.
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Pseudorabies Vaccine, Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a clarified, inactivated Suid herpesvirus 1 antigen concentrate produced in a defined porcine kidney cell substrate. The material is released under the manufacturer-specific code PRV-I-2025-04, although national licence dossiers may assign alternative identifiers. It is not a finished immunological product and is not administered directly to animals; it is intended solely for further manufacture by licensed veterinary biologics facilities into finished dosage forms.
Antigen harvests are clarified through 0.45 µm tangential-flow filtration and concentrated by ultrafiltration with a 300 kDa cut-off. Pre-inactivation virus titre is controlled at not less than 108.5 TCID50/mL. Virus inactivation uses binary ethylenimine at 1.5–3.0 mM for 24 h at 36 ± 1 °C, followed by neutralisation with sodium thiosulfate. Residual binary ethylenimine is limited to <5 ppm. Inactivation completeness is demonstrated by three blind passages in PK-15 cells observed for 21 days; any batch producing cytopathic effect at any passage is rejected.
Batch release is performed against a panel of identity, purity, safety, and potency criteria. The specifications below are applied to the unconcentrated antigen bulk and to the final API after formulation. For sterile liquid presentations intended for injection, the finished product must also meet the general requirements of 21 CFR 610.12 and Ph. Eur. 2.6.1 for sterility. Endotoxin burden is controlled because parenteral pseudorabies vaccines are frequently administered with adjuvants, and elevated endotoxin content may enhance injection-site reactivity.
| Parameter | Acceptance criterion | Reference method or standard |
|---|---|---|
| Identity | Positive SuHV-1 gB antigen reaction | In-house validated immunofluorescence |
| Pre-inactivation titre | ≥108.5 TCID50/mL | Cell culture titration in PK-15 cells |
| Residual live virus | None detected after three blind passages | PK-15 passage, 21-day observation |
| Sterility | No growth after 14 days in thioglycollate medium and tryptic soy broth | 21 CFR 610.12, Ph. Eur. 2.6.1 |
| Bacterial endotoxins | <0.5 EU/dose for parenteral use | Ph. Eur. 2.6.14 |
| Mycoplasma | Negative culture and indicator cell test | Ph. Eur. 2.6.7 |
| Residual inactivating agent | <5 ppm binary ethylenimine | Validated colorimetric assay |
| Antigen content | 64–128 ELISA units/mL by gB quantification | In-house sandwich ELISA |
| Relative potency | ≥1.0 against in-house reference vaccine | Guinea pig serology potency test |
| Residual moisture in dried API | <3% w/w | Ph. Eur. 2.5.32 |
The antigen content range is intentionally narrow because finished oral dosage forms may require higher antigen loading per unit mass than parenteral formulations. Finished-product potency must be confirmed after each intended dosage form because adsorption, compression, and enteric coating can alter antigen presentation.
For a liquid solution form, the term “solution” applies only to the concentrated antigen liquid before adjuvant addition. After addition of aluminium hydroxide gel or oil-in-water emulsion adjuvants, the final injectable presentation becomes a suspension. The liquid API is aseptically processed rather than terminal-filtered through sterilising-grade membranes because whole inactivated SuHV-1 particles exceed the nominal pore size of 0.22 µm sterilising filters.
Compatibility with aluminium hydroxide at 1.5–2.5% w/v is confirmed by determining antigen adsorption after 24 h at 2–8 °C. Adsorption below 95% may indicate competitive displacement by buffer ions or excessive phosphate concentration; this is corrected by reducing phosphate content to 5–10 mM and adjusting pH to 6.8–7.2. Oil-in-water adjuvants based on squalene or mineral oil are used less frequently for killed pseudorabies vaccines because local reactogenicity in swine can rise when the antigen is combined with high free-endotoxin loads.
If the production strain is a gE gene-deleted SuHV-1 isolate, the inactivated API retains DIVA compatibility, meaning vaccinated animals remain negative in gE ELISA while infected animals seroconvert to gE. This property is not automatic for all inactivated pseudorabies APIs: an inactivated wild-type SuHV-1 antigen contains gE and will induce gE antibodies, complicating eradication surveillance. Finished-product labelling should therefore state whether the input strain is gE-deleted or wild-type. In contrast, live attenuated gE-deleted pseudorabies vaccines are commonly used as marker vaccines in eradication programmes; the inactivated whole-virus API cannot replicate, so the risk of reversion to virulence is absent, but antigen mass per dose must be higher to achieve comparable serological responses.
| Attribute | Inactivated whole-virus API | Live gE-deleted attenuated API | Purified gB/gC subunit API |
|---|---|---|---|
| Replication in vaccinated animal | Absent | Present but attenuated | Absent |
| Reversion risk | Absent | Low | Absent |
| DIVA compatibility | Yes if gE-deleted input strain | Yes | Yes |
| Typical booster requirement | 2 doses | 1 dose may suffice | 2 doses |
| Thermal stability of API | Lyophilised, 2–8 °C | Lyophilised, 2–8 °C | Liquid, 2–8 °C |
| Antigenic repertoire | Whole virion, including envelope and tegument proteins | Whole virion, replicating | Selected glycoproteins |
Subunit APIs based on gB or gC may produce a narrower antibody profile and fewer unwanted reactogenic components, but they lack tegument and nucleocapsid epitopes that contribute to recognition of infected cells in some potency assays. The whole inactivated API retains the full virion-associated antigenic mass except where downstream processing removes host-cell impurities.
When the API is specified for oral premix rather than parenteral injection, the primary technical limitation is not antigen potency but gastric acid degradation. Inactivated SuHV-1 glycoproteins are denatured at pH below 5.0, and uncoated tablets or capsules release antigen in the porcine stomach where pH may fall to 2.0–3.5. Experimental oral bait formulations therefore use enteric coatings based on methacrylic acid copolymer type B or L applied at 5–8 mg/cm² to delay release until the proximal small intestine. Published data for commercial oral pseudorabies vaccine tablets is limited; most commercial killed pseudorabies vaccines are parenteral, and oral bait vaccines for wild boar are more frequently live or vector-based formulations.
Dry powder, granule, and premix forms require the API to be adsorbed onto a carrier such as microcrystalline cellulose, maltodextrin, or colloidal silica before blending with feed-grade excipients. In a top-spray fluid-bed granulator with a 50 L bowl, inlet air temperature may be set at 50 °C, but product-bed temperature must not exceed 35 °C. Antigen recovery falls when bed moisture exceeds 12% during spray granulation because partial rehydration of glycoprotein aggregates increases shear sensitivity. Direct compression of lyophilised or spray-dried API on a rotary tablet press should maintain compression force below 8 kN for 10 mm flat-faced punches; tablet hardness is typically controlled at 40–80 N and friability below 1.0% according to Ph. Eur. 2.9.7. Higher compression forces cause measurable loss of gB ELISA reactivity.
For capsules, the API powder is blended with lactose monohydrate and crospovidone, then filled at relative humidity below 40%. Pre-drying at relative humidity above 60% is required before dry blending because the lyophilised antigen is hygroscopic and develops adhesive bridging on punch faces and capsule-fill augers. The API is incompatible with acidified granulation fluids below pH 5.0 and with amine-based buffer systems that accelerate glycoprotein hydrolysis. It should not be combined with cationic polymers under acidic conditions because antigen aggregation increases particle size beyond the target <150 µm for uniform feed dispersion.
Premix production at feed-mill scale uses ribbon blenders or paddle mixers with gentle shear. Mixing time is typically 10–15 min after addition of the antigen-loaded silicon dioxide carrier. Over-mixing beyond 30 min does not improve blend uniformity and may generate electrostatic segregation of fine particles. Batch-to-batch variance in carrier oil absorption capacity is controlled by limiting carrier specific surface area to 180–250 m²/g for colloidal silica and by confirming loss on drying before antigen adsorption.
Production-scale inactivation is typically performed in stainless steel bioreactors with working volumes from 1,000 L to 2,500 L and bottom-mounted magnetic impellers. Inactivation kinetics are affected by incomplete mixing of binary ethylenimine after addition. In vessels with pitched-blade impellers operating at 80 rpm, uniform distribution may require 15 min of recirculation before the 24 h inactivation hold begins. Sampling from the lower drain has revealed residual inactivating agent concentrations 0.8 ppm higher than top-port samples where recirculation was inadequate. This gradient is corrected by sequencing the BEI addition through a static mixer or by using a dual-impeller configuration with a baffle insert.
Pre-inactivation titre variance exceeding 0.5 log10 TCID50/mL occurs when harvest pooling is not standardised by cell viability and time post-infection. Harvests with cell viability below 60% may contain increased host-cell protein and protease activity that reduces antigen integrity during storage. Host-cell protein is therefore controlled in the concentrated antigen to <50 µg/mL by ion-exchange polishing, and residual host-cell DNA is reduced to <10 ng/dose where required by regional regulatory guidance.
Storage of the formulated API outside 2–8 °C or freeze-thaw cycling beyond 3 cycles reduces gB antigen recovery. Liquid antigen concentrates are stored in closed stainless steel or high-density polyethylene containers under nitrogen overlay to limit oxidative damage. Dried forms are sealed in aluminium foil pouches with desiccant and maintained at 2–8 °C; residual moisture above 3% w/w shortens shelf life by accelerating aggregation. The API should not be exposed to oxidising disinfectants, strong acids, or high-shear homogenisation above 10,000 rpm because these conditions denature envelope glycoproteins and reduce potency. Published stability data for this specific multipurpose API configuration is limited to in-house real-time and accelerated studies; finished-product stability must be generated for each dosage form and adjuvant combination.
