| HS Code | 718741 |
| Product Name | Swine Infectious Pleuropneumonia Trivalent Vaccine, Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Type | Inactivated veterinary vaccine API |
| Disease Target | Swine Infectious Pleuropneumonia |
| Target Animal | Swine |
| Valency | Trivalent |
| Vaccine Nature | Inactivated (killed) bacterial vaccine |
| Pathogen Covered | Actinobacillus pleuropneumoniae serovars |
| Antigen Composition | Three selected inactivated serovars of Actinobacillus pleuropneumoniae |
| Adjuvant Status | Contains adjuvant to enhance immune response |
| Grade | Veterinary Grade API |
| Eligible Dosage Forms | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Function | Induces active immunity against swine infectious pleuropneumonia |
| Administration Route | Varies by final dosage form; commonly injectable for veterinary use |
| Storage Condition | Store according to final product specification, typically refrigerated at 2–8°C |
| Shelf Life | Determined by final formulation and packaging; per registered specification |
| Packaging | Bulk API packaging compliant with veterinary GMP requirements |
As an accredited Swine Infectious Pleuropneumonia Trivalent 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 package contains 100 mL of inactivated trivalent vaccine API in sterile, sealed vials for veterinary injection use. |
| Container Loading (20′ FCL) | 20′ FCL: vaccine API loaded in sealed containers/pallets, secured with bracing, temperature-controlled as needed, maximizing payload by volume and weight. |
| Shipping | Ship via temperature-controlled refrigerated transport at 2–8°C, protected from light and freezing. Use validated insulated packaging with coolant packs. Include temperature data loggers and biological hazard labeling. Ensure secure, leak-proof primary containers, clear documentation, and expedited delivery to maintain vaccine potency and stability. |
| Storage | Store under refrigerated conditions at 2–8°C. Protect from light, moisture, and freezing. Keep in tightly sealed original container in a well-ventilated area. Avoid heat and direct sunlight. Do not use beyond expiration date. Handle with care to maintain potency and sterility during processing and formulation. |
| Shelf Life | Shelf life is 24 months when stored at 2–8°C, protected from light, in unopened, intact original containers. |
The highest-volume downstream finishing route for this trivalent inactivated Actinobacillus pleuropneumoniae antigen is aseptic filling of an aluminum hydroxide-adjuvanted aqueous suspension for intramuscular injection in sows, gilts, and finisher pigs. Each of the three monovalent bulk concentrates is individually inactivated, sterility-tested, and quantified by capture ELISA or radial immunodiffusion before pooling. The pooled antigen is diluted with phosphate-buffered saline to a release dose commonly in the range of 1 × 109 to 5 × 109 inactivated bacterial cells per 2 mL dose, although exact release criteria are established in the marketing authorization dossier. Aluminum hydroxide gel is added to a final aluminum concentration of 0.5–1.0 mg/mL and mixed with a bottom-mounted magnetic drive impeller at 80–120 rpm for 60–90 min at 4–8°C. Adsorption efficiency is monitored by sedimentation velocity and residual antigen in the supernatant; an in-process limit of at least 85% adsorbed antigen is typically applied before filling. The suspension is not sterile-filtered because the particulate bacterial cell bodies exceed 0.22 µm; aseptic assembly from pre-sterilized components is therefore mandatory. Terminal product is filled into Type I borosilicate glass vials conforming to Ph. Eur. 3.2.1 and closed with bromobutyl rubber stoppers. Release testing includes sterility per Ph. Eur. 2.6.1, abnormal toxicity per Ph. Eur. 2.6.9, pH per Ph. Eur. 2.2.3, and antigen identity by the approved immunochemical method. Production-scale batches show that the principal bottleneck is final bulk settling during hold times exceeding 8 h at ambient temperature; the resulting compact sediment requires resuspension pulses above 500 rpm, and excessive shear at this stage disrupts cell-wall morphology and reduces vaccine potency.
Inactivated whole-cell Actinobacillus pleuropneumoniae antigen is not filter-sterilizable because the bacterial cell bodies exceed 0.22 µm, so the water-in-oil depot presentation is manufactured by aseptic emulsification rather than terminal sterile filtration. The aqueous antigen phase is prepared without aluminum hydroxide and then emulsified into a light mineral oil phase containing mannide monooleate as surfactant. Typical formulation ratios are aqueous phase 30–40% v/v, oil phase 55–65% v/v, and emulsifier 4–6% v/v. Primary emulsification is carried out with an in-line rotor-stator at 10,000–15,000 rpm until the coarse emulsion reaches a droplet size Dv90 below 20 µm. High-pressure homogenization at 500–800 bar for 2–4 passes reduces Dv90 to 5 µm or below, measured by laser diffraction per ISO 13320:2020. Viscosity is controlled to 40–120 mPa·s at 25°C according to Ph. Eur. 2.2.9; emulsions above this range show poor syringeability through 20-gauge needles. Stability evaluation includes storage at 4°C, 25°C, and 37°C for up to 28 days; creaming exceeding 5% of total volume at 4°C is cause for rejection. The terminal product is a white to off-white opaque emulsion filled into sterile Type I vials, labeled as a depot injectable. A documented incompatibility is the presence of free fatty acids above 0.1% in the oil phase, because lipase activity carried over from bacterial cell-wall phospholipids can destabilize the interfacial film. On production scale, phase inversion is observed when the aqueous phase is added too rapidly; the addition rate is therefore limited to 1 L/min per 50 L batch under continuous recirculation.
For lyophilized vial presentations, the pooled trivalent antigen concentrate is exchanged into a protective matrix by tangential-flow diafiltration using 100 kDa membrane cassettes. The matrix typically contains trehalose or sucrose at 3–5% w/v, mannitol at 1–2% w/v, and phosphate buffer at 5–10 mM with pH 7.0–7.4. The final bulk is filled at 2.0 mL per 6 mL vial and lyophilized. Freezing is performed on the shelf at -45°C for 4 h; primary drying is executed with shelf temperature ramping to -20°C under chamber pressure of 0.1–0.2 mbar. Product temperature must remain below the collapse temperature, which for sucrose-based matrices is approximately -32°C to -35°C; this is verified by comparison of Pirani and capacitance manometer readings. Secondary drying at 25°C for 6–8 h reduces residual moisture below 3.0% by Karl Fischer titration per Ph. Eur. 2.5.12. The terminal product is a white to off-white cake, reconstituted with 2 mL water for injection to a uniform suspension. A production bottleneck observed in multi-shelf lyophilizers is vial-to-vial heat transfer variation at the edge rows; edge vials may reach product temperatures 3–5°C higher than center vials, causing microcollapse and longer reconstitution time. This differential is managed by loading a full shelf, using door-side shields, and limiting total batch to 80% of nominal shelf area.
For oral solid dosage forms, the trivalent inactivated antigen is incorporated into enteric-coated tablets or hard capsules only when the objective is mucosal priming in weaned piglets, not primary parenteral immunity. The antigen is first spray-dried with trehalose and sodium alginate at a ratio of 1:1:0.3 w/w to form a free-flowing powder with residual moisture below 5.0%. This powder is blended with microcrystalline cellulose and croscarmellose sodium; a typical tablet core composition is 10–15% w/w antigen powder, 60–70% filler, 5–10% disintegrant, and 0.5–1.0% magnesium stearate. Compaction is performed on a rotary tablet press at 8–12 kN compression force to achieve hardness of 50–90 N. Cores are then coated with a methacrylic acid-ethyl acrylate copolymer dispersion to a weight gain of 8–12%. The enteric coat is required because unprotected inactivated bacterial antigen loses detectable immunoreactivity after 30 min at pH 1.2 in compendial dissolution media. Capsule fill uses the same spray-dried powder in size 3 hard gelatin capsules, with a fill weight of 200–250 mg. Published data for this specific configuration is limited; release criteria are usually confined to potency retention after acid challenge rather than a pharmacopoeial vaccine potency test. The main incompatibility is the use of croscarmellose sodium in high-humidity environments; above 60% RH it exerts internal stress on the enteric coat and causes premature opening.
| Dosage form | Typical antigen load | Critical process parameter | Reference method | Known failure or operational boundary |
|---|---|---|---|---|
| Aqueous injection | 1 × 109–5 × 109 cells per 2 mL | Adsorption pH 6.0–6.8 | Ph. Eur. 2.6.1; Ph. Eur. 2.6.9 | Sedimentation after 8 h hold; resuspension shear must not exceed 500 rpm |
| Water-in-oil injection | Aqueous phase 30–40% v/v | Homogenization pressure 500–800 bar | ISO 13320:2020; Ph. Eur. 2.2.9 | Phase inversion if aqueous phase addition exceeds 1 L/min per 50 L batch |
| Lyophilized powder | 2.0 mL fill per 6 mL vial | Product temperature below collapse threshold -32°C to -35°C | Ph. Eur. 2.5.12 | Edge-vial microcollapse at 3–5°C higher product temperature |
| Enteric tablet/capsule | 10–15% w/w antigen powder | Enteric coating weight gain 8–12% | Compendial acid challenge at pH 1.2 | Premature coat opening above 60% RH |
| Feed premix/granule | 0.5–1.0 kg/ton in complete feed | Fluid-bed product temperature 35–40°C | Residual moisture below 5.0% | Steam pelleting above 70°C reduces potency by more than 1 log |
When oral mass administration is required across a large nursery site, the inactivated trivalent antigen is prepared as a feed premix or microgranule. The antigen is adsorbed onto calcium carbonate or pregelatinized starch carrier at a ratio of 10–20 parts antigen concentrate to 80–90 parts carrier, then spray-granulated in a fluid-bed processor. Inlet air temperature is held at 50–60°C and product temperature at 35–40°C; exhaust humidity above 12 g/kg dry air causes particle agglomeration and non-uniform antigen distribution. The granulate is dried to residual moisture below 5.0% and passed through a 1000 µm screen. Terminal premix is mixed into complete feed at 0.5–1.0 kg/ton as a top-dress or pelleting-exempt component; steam-conditioned pelleting above 70°C is to be avoided because it reduces antigen potency by more than 1 log in recovery ELISA. Batch-to-batch variance on production farms is frequently driven by segregation during silo transfer; the granular API is therefore blended with 2–3% vegetable oil to reduce electrostatic separation. The terminal product is a free-flowing granule in 25 kg multilayer paper bags with polyethylene liner, stored below 25°C and 60% RH.
A separate finishing route is the production of a liquid oral drench for individual piglet dosing after weaning. The trivalent antigen is dispersed in an aqueous vehicle containing glycerin 10–20% v/v, sodium citrate 0.5–1.0% w/v, and potassium sorbate 0.1–0.2% w/v as preservative. The pH is adjusted to 6.5–7.0 with hydrochloric acid or sodium hydroxide. The final antigen load is adjusted to 5–10% v/v of bulk concentrate. The product is filled into plastic squeeze dosing bottles or 1 L high-density polyethylene bottles with a dosing pump. Stability at 2–8°C for 12 months is supported by the absence of visible sedimentation and pH drift less than 0.2 units. The main process constraint is that the product cannot be terminally sterilized by filtration; aseptic compounding from pre-sterilized vehicle is required. Autoclaving is excluded because 121°C for 15 min destroys antigenic epitopes and increases free lipopolysaccharide. On-farm administration is via a drench gun calibrated to deliver 2 mL per piglet.
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Commercial documentation that classifies an inactivated bacterial vaccine under the phrase “veterinary grade API for tablets / injections / capsules / powders / granules / premix / solutions” introduces a product-class ambiguity requiring immediate clarification. The active substance is a killed Actinobacillus pleuropneumoniae whole-cell antigen concentrate, not a chemically defined small-molecule active pharmaceutical ingredient. Regulatory systems define this material as a veterinary biological active substance intended for formulation into parenteral immunological products. The term “API” is therefore a supplier convention; the compendially appropriate description is “antigen concentrate” or “active substance for immunological product.” Tablets and capsules do not represent recognised finished-product presentations for this antigen. Published data for tablet or capsule delivery of inactivated pleuropneumonia vaccines is limited, and no compendial monograph supports oral administration as a primary route for achieving protective systemic immunity in swine.
No universal model number exists for this product class. The registered article code is manufacturer-specific and jurisdiction-specific; it has no WOAH or pharmacopoeial status. The material is specified by serovar composition, inactivation marker, antigen content, adjuvant identity, sterility, pH, endotoxin burden, and stability profile rather than by a harmonised trade model. Finished-dose labels must declare the serovars and the recommended dose volume. A frequently encountered registered dose is 2 mL by intramuscular injection, although alternative dose volumes and schedules appear in regional registrations. Where the product is supplied as a bulk concentrate, the downstream dose volume is determined after formulation and potency adjustment.
Three specified capsular serovars of A. pleuropneumoniae are propagated separately in liquid culture under aerobic or microaerophilic conditions, inactivated with a process validated to render each culture non-viable, and blended with an adjuvant. Inactivation is confirmed by two consecutive blind passages in a suitable growth medium; no viable organisms may be recovered. Sterility is controlled according to Ph. Eur. 2.6.1 or the corresponding 9 CFR Part 113 sterility test. Antigen content is expressed as relative potency against a qualified reference vaccine by ELISA, quantitative agglutination, or an equivalent validated method. Endotoxin content is controlled because Gram-negative whole-cell vaccines carry lipopolysaccharide; the registered limit must be justified by safety data in the target animal. Aluminium hydroxide gel and mineral-oil adjuvants are the two most common adjuvant systems. Aluminium adjuvants are sensitive to freezing, and oil-emulsion forms require dedicated high-shear homogenisation equipment to achieve droplet-size distributions in the range of 1–10 μm for stable water-in-oil or oil-in-water emulsions.
| Release parameter | Typical method / standard | Criterion observed in routine control |
|---|---|---|
| Identity and serovar specificity | Slide agglutination, PCR, or immunodiffusion | Positive for each declared serovar |
| Inactivation completeness | Two-passage culture | No growth after 37°C incubation |
| Sterility | Ph. Eur. 2.6.1 / 9 CFR Part 113 | No microbial growth |
| Relative potency | ELISA or agglutination against reference | ≥ 1.0 relative potency unit per dose |
| pH | Potentiometry | 6.8–7.4 for aqueous suspension |
| Endotoxin | Ph. Eur. 2.6.14 LAL | ≤ manufacturer-registered limit |
| Aluminium content | Inductively coupled plasma optical emission spectrometry | Consistent with registered formulation |
| Extractable protein / antigen content | BCA or Lowry after desorption | Consistent with batch reference |
For parenteral vaccination, the finished suspension is warmed to room temperature and resuspended by gentle inversion. High-shear shaking is avoided because aluminium hydroxide flocs can aggregate irreversibly. The injection route is intramuscular in the neck behind the ear. Primary immunisation typically requires two doses 3–4 weeks apart, with the booster administered before the period of highest exposure risk. Protection is serovar-specific and does not extend equally to unrepresented serovars. Gilts may be vaccinated pre-farrowing to support colostral transfer, but that use must be stated on the registered label; extrapolation from other products is not valid without regulatory approval.
The liquid injectable presentation is the reference form with the most defined stability boundaries. Bulk or finished aqueous suspensions should be stored at 2–8°C; freezing causes irreversible aggregation of aluminium hydroxide adjuvants and antigen desorption. pH adjustment below 5.5 or above 8.5 can destabilise the bacterial cell suspension and change surface charge. Any dilution must use isotonic saline or the diluent specified in the registration. Heat above 40°C for extended periods reduces potency; terminal sterilisation by moist heat is not applicable to adjuvanted whole-cell vaccines, and aseptic processing after inactivation is required.
If a powder or granule intermediate is prepared, lyophilisation is the most technically credible drying route. The process requires a cryoprotectant matrix, typically sucrose or mannitol, and low residual moisture, often below 3% where stability data support that threshold. During lyophilisation, the shelf ramp rate is controlled below 1°C/min through the collapse temperature of the amorphous cryoprotectant matrix; exceeding the collapse temperature produces a cracked cake and poor reconstitution. Spray drying of adjuvanted inactivated bacterial vaccines is less common because inlet temperatures commonly above 120°C and outlet temperatures above 50°C can damage capsular antigen epitopes and alter adjuvant particle-size distribution. Aqueous granulation with high-shear mixers may generate sufficient mechanical energy to increase product temperature; jacketed cooling and in-process temperature monitoring are required above pilot scale. Published data for this specific configuration is limited, and any dried presentation must be justified by real-time and accelerated stability data generated on the final formulation, not by analogy to small-molecule APIs.
The “solution” and “premix” descriptors require separation of claims. A solution is thermodynamically monophasic; a whole-cell bacterial vaccine with or without adjuvant is a suspension, not a true solution. Premix use in feed or drinking water is not an approved route for this antigen and would expose the immunogen to gastric proteolysis, intestinal dilution, and first-pass mucosal degradation. Solubilising agents or high-ionic-strength buffers may precipitate aluminium adjuvants and should be avoided unless compatibility has been demonstrated by particle-size analysis and potency testing. For liquid suspension, acceptable ionic strength is limited to the registered isotonic range; hypertonic sodium chloride solutions above 0.9% may induce adjuvant flocculation. Injectable suspensions are commonly tested for particle-size distribution by laser diffraction; a typical upper limit is 20 μm for D90 to ensure syringeability, but the exact value must be read from the product dossier.
Tablet and capsule formats are inappropriate for this antigen class. Compression pressures typical of rotary tablet presses—frequently 50–200 MPa at the punch face—would shear bacterial cells and adjuvant gels, and the enteric environment would degrade protein and polysaccharide epitopes. No compendial test design is available for release of inactivated bacterial vaccines from a tablet or capsule because the finished-product category is not recognised for vaccines. The supplier listing should therefore be interpreted as a broad material classification rather than a claim that all listed dosage forms are technically valid.
Compared with monovalent inactivated vaccines, the trivalent product reduces the number of injections and extends serovar coverage, but it does not reduce the need for serovar-specific diagnosis. Compared with bivalent products, the addition of a third well-matched serovar can improve protection where that serovar circulates in the herd, but cross-protection against heterologous serovars is incomplete. Compared with live attenuated or subunit toxoid vaccines, the inactivated whole-cell vaccine carries a different safety profile: reversion to virulence is not relevant, but the endotoxin content is higher and the onset of immunity may be slower. Subunit vaccines based on Apx toxins can provide broader cross-serovar protection because Apx toxins are shared across multiple serovars, whereas whole-cell bacterins are more serovar-dependent.
| Product class | Serovar coverage | Safety constraints | Onset and duration profile |
|---|---|---|---|
| Trivalent inactivated whole-cell | Declared serovars only; limited heterologous protection | Higher Gram-negative endotoxin load; injection-site reactions possible | Slower onset; booster required; duration depends on adjuvant and exposure |
| Monovalent inactivated | Single declared serovar | Lower antigenic bandwidth; multiple vaccines may be needed | Similar onset; narrower coverage |
| Bivalent inactivated | Two declared serovars | Intermediate endotoxin load | Intermediate coverage |
| Subunit Apx toxoid | Broad but not necessarily all serovars; cross-reactivity via Apx toxins | Lower endotoxin burden; may require more refined purification | Often used where toxin neutralisation is the primary protective mechanism |
| Live attenuated | Usually serovar-specific; may stimulate mucosal immunity | Reversion risk assessed; not suitable for all herd statuses | May induce earlier mucosal immunity; shedding and vaccine-strain persistence require control |
Field failure of pleuropneumonia vaccination is most often traced to a mismatch between the serovars in the product and the serovars isolated from lung lesions. A trivalent product containing the three epidemiologically dominant serovars in a region cannot be assumed to protect against an autogenous strain of a different capsular serovar. Cross-protection is occasionally reported between phylogenetically related serovars, but it is not uniform and must not replace bacteriological isolation and serotyping. In herds with mixed serovar challenge, vaccination with a commercial trivalent product may be supplemented by an autogenous bacterin prepared from the isolate; this is accepted veterinary practice where regional regulations permit. The final decision should be based on isolation, antimicrobial susceptibility, and serotyping, not on the product class name alone.
Storage and handling limits are specific to the finished formulation. For aqueous suspension, the container must not be frozen, and the label should specify gentle shaking before use. High-shear mixing or prolonged vigorous shaking can break the aluminium hydroxide floc structure and reduce syringeability. Any transfer to a separate dosing container must be performed under aseptic conditions because opened multi-dose containers are susceptible to microbial contamination. Residual material in a punctured vial should be discarded according to regional biosecurity requirements. For bulk antigen, validated clean-in-place and sterilisation-in-place procedures must be used after processing; Gram-negative antigen residues can form biofilms on stainless-steel surfaces if not removed with an alkaline detergent followed by an acid rinse. The product is not compatible with cationic disinfectants used as terminal sterilants for enclosed processing equipment, and any contact with glutaraldehyde or quaternary ammonium compounds should be avoided unless removal has been validated by surface residue testing.
