| HS Code | 801248 |
| Product Name | Bovine Pasteurella multocida Vaccine, Inactivated Veterinary Grade API |
| Veterinary Indication | Active immunization of cattle against bovine pasteurellosis caused by Pasteurella multocida |
| Target Pathogen | Bovine-specific Pasteurella multocida strains |
| Antigen Form | Inactivated whole-cell bacterial antigen |
| Inactivation Method | Chemically inactivated to retain immunogenicity while eliminating pathogenicity |
| Biological Response | Induces protective antibodies and active immunity in cattle |
| Adjuvant Compatibility | Compatible with aluminum-based, oil-emulsion, and other veterinary-approved adjuvants |
| Veterinary Grade | Manufactured under veterinary GMP compliance for animal health use |
| Presentation Forms | Formulated into tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Bovine Pasteurella multocida 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 | Supplied as sterile veterinary-grade bulk in sealed, tamper-evident glass vials; 100 mL per vial, ready for pharmaceutical formulation into tablets, injections, or other dosage forms. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): Inactivated bovine Pasteurella multocida vaccine API, veterinary grade, temperature-controlled, packaged in sealed drums/pallets for pharmaceutical manufacturing. |
| Shipping | Shipment requires strict temperature-controlled logistics (2–8°C), insulated containers with validated coolants, and tamper-evident sealing. Include veterinary biological permits, SDS, and cold-chain monitoring devices. Use expedited air freight to minimize transit time. Ensure compliance with IATA/ADR hazardous goods regulations and country-specific import requirements for veterinary vaccines. |
| Storage | Store at 2–8°C (refrigerated) in original, tightly closed container. Protect from light, moisture, and freezing. Do not use beyond expiry. This inactivated veterinary API should remain stable when handled under cold-chain conditions; avoid temperature fluctuations during storage and transport. For professional veterinary use only. Dispose of unused product per local regulations. |
| Shelf Life | Shelf life is 24 months when stored at 2–8°C, protected from light, and not frozen. |
Downstream applications of inactivated Pasteurella multocida antigen are limited to parenteral immunological products. Tablet, capsule, granule, and feed-premix matrices lack published regulatory monographs and oral immunogenicity data for this killed bacterial antigen; no addition ratio can be assigned to unsupported dosage forms.
Inactivated Pasteurella multocida serotypes B:2 and E:2 are formulated as a whole-cell bacterin adsorbed onto 2% w/v aluminium hydroxide gel for subcutaneous administration to cattle and buffalo in haemorrhagic septicaemia-endemic regions. Compliance references are the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Chapter 3.4.12, Ph. Eur. monograph 0062 for veterinary vaccines, and 9 CFR 113.68 where the bovine isolate potency test is applied to the finished product. Because the antigen is a killed bacterial suspension rather than a soluble molecule, the formulation addition rate is expressed as a relative potency release value instead of a dry-weight percentage: the final bulk is blended so that the finished dose meets the challenge-test requirement of ≥1.0 RP against the homologous reference bacterin in the mouse potency model. This typically requires a clarified fermenter concentrate volume between 10% v/v and 30% v/v of the final bulk, with the balance composed of sterile buffered saline and aluminium hydroxide gel. Downstream production at commercial scale begins with fed-batch fermentation of the relevant serotype on casein-sucrose-yeast extract broth to late exponential phase, usually 12–18 h post-inoculation before rapid autolysis raises free endotoxin and destabilises batch-to-batch antigenic mass. The harvest is inactivated with 0.2–0.5% v/v formalin at 35–37 °C until culture negativity is confirmed, then concentrated by tangential-flow filtration using 0.1–0.2 µm cassettes, washed against phosphate-buffered saline at pH 7.0–7.4, and adsorbed with low-shear mixing because high-shear dispersion of aluminium hydroxide gel causes gel fracture and sedimentation. Filling into 50 mL, 100 mL, or 250 mL rubber-stoppered vials occurs under ISO 14644-1 Class 5 conditions, with in-process checks for pH, antigenic mass by ELISA, endotoxin load by Limulus amebocyte lysate testing per Ph. Eur. 2.6.14, and aluminium content by complexometric titration. Terminal finished products are ready-to-use injectable suspensions of 2 mL for cattle and 3 mL for buffalo, administered subcutaneously, with revaccination intervals determined by serological monitoring rather than by a fixed formulation parameter.
In feedlot BRD combination products, the inclusion of Pasteurella multocida type A:3 antigen into a water-in-oil emulsion is controlled by emulsification parameters rather than by simple volumetric addition, because antigen denaturation at the oil-water interface can reduce potency before the final vial is assembled. The controlling standards are 9 CFR 113.68 for the bovine Pasteurella fraction, Ph. Eur. 0062 for the finished immunological product, and 21 CFR 610.12 for sterility assurance of the emulsion. The addition ratio is defined as the proportion of aqueous antigen phase relative to the mineral-oil continuous phase; production records typically use 30–50% v/v aqueous phase containing 10–30% v/v bacterial concentrate, 50–70% v/v light mineral oil, and 2–5% v/v emulsifier system of sorbitan monooleate and polysorbate 80, with final dose volume fixed at 2 mL for subcutaneous administration. Downstream processing on production-scale rotor-stator mixers, typically 3,000–10,000 min⁻¹ for 10–30 min, generates a primary water-in-oil emulsion; the process-limiting control is not shear time alone but oil phase temperature, maintained below 25 °C because higher thermal input accelerates antigen degradation at the interface. Droplet size is measured by laser diffraction after emulsification, with an acceptance limit of D90 <5 µm and viscosity of 20–80 mPa·s at 25 °C per ISO 3219; larger droplets produce phase separation during 12-month storage at 2–8 °C, and submicron droplets can raise injection-site reactivity without improving immunogenicity. Terminal finished product types are injectable emulsions supplied in 50-dose and 250-dose multi-dose vials, often combined with Mannheimia haemolytica leukotoxoid and Histophilus somni bacterin fractions after antigen compatibility testing; the Pasteurella component must be re-qualified for relative potency after final emulsification because the emulsification step itself can reduce recoverable antigen mass depending on mixer configuration.
| Control parameter | Acceptance range | Method |
|---|---|---|
| Droplet size D90 | D90 <5 µm | laser diffraction |
| Viscosity | 20–80 mPa·s at 25 °C | ISO 3219 |
| Aqueous phase fraction | 30–50% v/v | batch record |
| Storage stability | 2–8 °C, no phase separation for 12 months | visual and centrifugation |
Freeze-drying of an inactivated Pasteurella multocida antigen for tropical distribution shifts the stability-limiting variable from cold-chain liquid storage to residual moisture and cake collapse. The applicable quality anchors are Ph. Eur. monograph 0062, Ph. Eur. 2.5.12 for water content, and the general sterility requirements of Ph. Eur. 2.6.1. The formulation addition ratio is expressed as stabiliser-to-antigen solids mass, commonly 1:1 to 4:1, with sucrose at 2–5% w/v and mannitol at 1–2% w/v in the pre-lyophilisation bulk; the inactivated bacterial pellet itself remains the variable mass component and is adjusted after ELISA or total protein quantification. Downstream lyophilisation proceeds by freezing the filled vials to -40 °C, holding for 3–6 h, then initiating primary drying at shelf temperatures of -20 °C to -10 °C under 50–100 µbar chamber pressure. The product temperature must remain below -25 °C during primary drying because the maximally freeze-concentrated glass transition temperature of sucrose-based formulations is approximately -32 °C; collapse above this boundary produces a dense, shrunken cake with reconstitution times exceeding 60 s and visible meltback. Secondary drying is then conducted at 25–35 °C until residual moisture reaches ≤3% by Karl Fischer titration. Terminal finished products are lyophilised powders in glass vials for reconstitution to 2 mL with sterile diluent immediately before subcutaneous injection; the powder is not a feed premix or granulated oral product, and published data for such matrices are absent.
| Parameter | Limit | Method |
|---|---|---|
| Tg' of sucrose formulation | -32 °C | differential scanning calorimetry |
| Product temperature during primary drying | ≤ -25 °C | product thermocouple |
| Residual moisture | ≤ 3% | Ph. Eur. 2.5.12 |
| Reconstitution time | ≤ 60 s | manual swirling |
Autogenous bacterin production for dairy calf pneumonia outbreaks uses Pasteurella multocida isolates recovered from transtracheal lavage or post-mortem lung tissue, not reference challenge strains, which changes the formulation logic from fixed batch potency to herd-specific antigenic matching. Compliance references include USDA 9 CFR 113.113 for autogenous biologics, Ph. Eur. 0062, and Regulation (EU) 2019/6 for veterinary medicinal products prepared on prescription. The addition ratio is not a fixed percentage because field isolates vary in growth rate and antigenic mass; the bacterial suspension is standardised to 10⁸–10⁹ CFU equivalents per mL before inactivation, and the final dose volume is set by the attending veterinarian, commonly 2–4 mL subcutaneously. Downstream processing starts with isolate purification on blood agar, followed by submerged culture in stabilised broth to an optical density at 600 nm that corresponds to late exponential phase, typically 0.8–1.2 depending on the isolate. Formaldehyde inactivation is performed at 0.2–0.5% v/v for 24 h at 35–37 °C, with completion confirmed by culture negativity, after which the inactivated suspension is adjuvanted with aluminium hydroxide gel and filled aseptically into single-animal or multi-animal vials. Terminal finished product types are injectable suspensions for subcutaneous administration, restricted to the originating herd or veterinary prescription; autogenous Pasteurella multocida bacterins are not licensed for commercial interstate or international distribution unless the receiving jurisdiction maintains an equivalent autogenous biologics pathway.
Bulk aqueous antigen concentrate shipment is the standard trade format for converting inactivated Pasteurella multocida fermentation output into local finished vaccines without transferring the full fermentation line. The compliance framework for this intermediate is 21 CFR 610.12 for sterility assurance of the concentrate, Ph. Eur. 0062 for the downstream immunological product, and Ph. Eur. 2.6.7 for mycoplasma absence where local registration requires it. The addition ratio is defined as a concentration factor rather than a finished-dose percentage: the concentrate is supplied at 10–50× the final dose strength, and the receiving fill-finish operation dilutes it with sterile phosphate-buffered saline at pH 7.0–7.4 before adjuvant addition. Downstream processing at the supplying facility includes fed-batch fermentation, formalin inactivation, tangential-flow concentration with 0.1–0.2 µm cassettes, repeated diafiltration to remove medium residues, and aseptic transfer into single-use bioprocess bags. The concentrate is maintained at 2–8 °C during shipment; freeze-thaw cycling must be avoided because lysis of killed Gram-negative cells releases free endotoxin and raises viscosity beyond the acceptable range for downstream sterile filtration of the final aqueous phase. At the fill-finish site, the diluted antigen is mixed with aluminium hydroxide or emulsified with mineral oil, then filled into vials or syringes. Terminal finished product types are injectable solutions, suspensions, or emulsions registered by the regional manufacturer; tablets, capsules, granules, and premixes are not a supported downstream format for this killed bacterial antigen because no published oral immunogenicity or enteric stability data define a valid addition ratio.
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Bovine Pasteurella multocida Vaccine, Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a killed bacterial antigen concentrate derived from a defined Pasteurella multocida master seed of bovine origin. The product is an active pharmaceutical intermediate for veterinary immunobiological manufacturing, not a finished vaccine. It is supplied as either an aqueous suspension or a lyophilized powder. The inactivated biomass contains whole bacterial cells or antigenic fragments of the declared capsular type, typically type A or type B, associated with bovine respiratory disease or hemorrhagic septicemia. The preparation is non-viable; no replication-competent organisms are present. Inactivation is performed with a validated chemical agent, usually formaldehyde solution or binary ethylenimine, followed by neutralization or removal of residual inactivant. The API is intended solely for further processing into dosage forms including injectable emulsions, aqueous solutions, freeze-dried powders, granules, premixes, tablets, or capsules where regulatory approval exists for those routes.
The product is identified by the strain designation, master seed lot, and date reference rather than by a universal commercial model code. A monovalent model is released against a certificate of analysis that declares capsular type, antigenic mass, inactivation method, preservative or stabilizer content, and storage temperature. Liquid presentations are stored at 2–8 °C and should not be frozen unless the supplier has validated freeze-thaw stability. Freeze-dried presentations are stored at 2–8 °C for routine distribution and may tolerate controlled ambient excursions only within supplier-defined limits. The material is not intended for direct administration to animals.
The release profile is composed of identity, inactivation, sterility or bioburden, antigenic mass, pH, total solids, residual moisture, and residual inactivant. Identity confirmation uses a Pasteurella multocida-specific polymerase chain reaction from the fermentation harvest; capsule type is confirmed by slide agglutination or molecular capsule typing. Under United States Department of Agriculture jurisdiction, the relevant standard is USDA 9 CFR 113.70, which covers Pasteurella multocida bacterin potency and safety testing. In the European system, the relevant monograph is Ph. Eur. 0362, bovine pasteurellosis vaccine inactivated. Potency is normalized to a reference bacterin. For USDA-regulated finished product, the prescribed potency method is a vaccination-challenge test relative to reference; manufacturers may use an approved in vitro antigen quantification method only after establishing correlation with the challenge model. The API is therefore formulated to a declared antigenic mass per unit volume or per gram dry weight, not simply to total bacterial cell count.
| Attribute | Control range / limit | Reference method |
|---|---|---|
| Identity and capsular type | P. multocida–specific amplicon detected; capsular type A or B declared | USDA 9 CFR 113.70, Ph. Eur. 0362 |
| Inactivation | No growth on blood agar or in thioglycolate medium after subculture | Inactivation test per USDA 9 CFR 113.70 |
| Sterility / bioburden | Sterile for injectable grade; harmonized bioburden limit for oral grade | USP <71>, Ph. Eur. 2.6.1 |
| pH | 6.0–7.5 | USP <791>, Ph. Eur. 2.2.3 |
| Total solids, liquid concentrate | 5.0–15.0% w/v, lot-specific | Gravimetric drying |
| Residual moisture, freeze-dried | ≤2.0% | Karl Fischer USP <921>, Ph. Eur. 2.5.12 |
| Residual free formaldehyde | ≤0.05% if formaldehyde inactivation is used | Validated colorimetric or HPLC method |
| Endotoxin, injectable grade | Lot-specific action limit | USP <85>, Ph. Eur. 2.6.14 |
Inactivation kinetics are temperature- and pH-dependent. Production-scale inactivation is commonly performed at 37 °C ± 1 °C for 18–24 h with continuous agitation. Batch records from fermenter-based manufacture show that failure to control pH above 6.5 during inactivation can reduce reaction rate and leave residual viable organisms. Over-neutralization with sodium metabisulfite after formaldehyde inactivation may increase osmolality beyond 350 mOsm/kg and should be avoided because cell lysis releases free nucleic acids and raises viscosity. The inactivated bulk is clarified through depth filtration or low-speed centrifugation; sterilizing-grade filtration is not used for whole-cell suspensions because the cell aggregates exceed 0.45 µm in diameter.
Batch-to-batch variance in antigen density is a known production bottleneck. Fermentation is harvested at a fixed optical density at 600 nm; the target value is lot-specific and deviations greater than ±0.3 AU from the validated harvest window alter downstream concentration factor and final antigenic mass. The inactivated biomass is concentrated by tangential-flow filtration or continuous centrifugation. Tangential-flow units with 100–300 kDa membrane cutoffs retain bacterial cells and high-molecular-weight antigens while allowing low-molecular-weight medium residues to pass. Continuous disk-stack centrifugation is used for large-volume harvests; solids loading above 2.0% w/v increases sludge discharge frequency and can produce inconsistent cell recovery. These operations are monitored by dry cell weight rather than only optical density, because cell lysates and media pigments interfere with absorbance at 600 nm.
Formulation into injectable finished vaccines requires aseptic blending with an aluminum hydroxide or mineral-oil adjuvant. Stainless-steel jacketed vessels with magnetic-drive agitation are preferred. High-shear rotor-stator dispersion is limited to the minimum duration required for emulsion formation. In industrial compounding runs for oil-adjuvanted bacterins, a rotor-stator tip speed above 10 m/s raises the local temperature by more than 5 °C/min and produces measurable antigen loss by ELISA. Jacket cooling at 15–20 °C and high-shear intervals of 3–5 min/L are used to hold bulk temperature below 25 °C. Filtration of the final whole-cell emulsion through 0.22 µm sterilizing membranes is not feasible; the product is manufactured by aseptic processing. Terminal sterility is therefore dependent on media-fill qualification, environmental monitoring, and container-closure integrity testing. The same constraint does not apply to soluble subunit Pasteurella vaccines, which may be sterile-filtered before filling.
Freeze-dried injection and powder presentations require a cryoprotectant matrix. Typical lyophilization parameters for bacterin concentrates include freezing to −45 °C, primary drying at −20 °C to −10 °C and chamber pressure of 50–150 µbar, and secondary drying at 25–35 °C to a residual moisture end point of ≤2.0%. Collapse during primary drying occurs when the product temperature exceeds the glass transition temperature; this is detected by batch comparative pressure measurement or visual inspection and results in poor reconstitution. For oral granules and premixes, the aqueous antigen concentrate is applied to lactose or maltodextrin carriers in a fluid-bed granulator. Inlet air temperature is generally controlled at ≤45 °C. Published stability data for oral capsule and tablet forms containing inactivated Pasteurella multocida are limited; the drying and compression limits should therefore be established case-by-case using antigen recovery ELISA because the antigen is thermally labile above 50 °C in unprotected matrices.
The choice of inactivation agent affects residual chemistry and downstream compatibility. Formaldehyde-inactivated lots require neutralization with sodium metabisulfite; excess bisulfite can be quantified by ion chromatography and should be controlled because it may react with protein amino groups during storage. Binary ethylenimine inactivation avoids carbonyl-reactive residuals but requires complete hydrolysis of the inactivant before harvest. Aqueous concentrates produced by either route are not suitable for terminal autoclaving; any manufacturing step above 50 °C must be supported by antigen stability data using a serological or ligand-binding assay. Endotoxin levels in whole-cell Pasteurella preparations are inherently higher than in purified recombinant vaccines; the release limit for injectable intermediates is therefore set to control batch consistency and is not an in-process specification for finished product safety unless the relevant competent authority requires a defined endotoxin limit in the final dosage form.
The clinical use of the API is directed by the finished product authorization. Injectable finished products are administered to cattle or bison by subcutaneous or intramuscular injection for active immunization against Pasteurella multocida infection. The dose volume, booster interval, and minimum age are established in the approved product literature. The API should not be administered directly. Powders, granules, and premixes intended for oral use are not conventional primary systemic immunization presentations for this antigen; those forms are used for mucosal exposure studies or in jurisdictions where an oral claim has been specifically authorized. Solutions may be aqueous or emulsion-based; a solution presentation for injection should be visually inspected for flocculation, creaming, or phase separation before filling.
Compared with live attenuated Pasteurella multocida vaccines, the inactivated API contains no replication-competent organisms; there is therefore no vaccine-strain shedding or reversion risk. The trade-off is that inactivated whole-cell preparations usually require adjuvants and booster doses. Compared with purified subunit or toxoid preparations, the inactivated whole-cell product retains capsular polysaccharides, outer membrane proteins, lipopolysaccharide, and other particulate antigens. This broader antigenic profile can support recognition of multiple serotype-associated antigens, but it also increases endotoxin load in the parenteral presentation. The inactivated API also differs from autogenous bacterins in that it is produced from a defined master seed rather than a field isolate from a single herd. Autogenous products are prepared from isolates submitted by a veterinary practice and are intended for limited use in a defined herd or region; commercially licensed API is released against a standardized antigenic mass and potency test. The table below summarizes these differences.
| Attribute | This inactivated whole-cell API | Live attenuated culture | Purified subunit / toxoid |
|---|---|---|---|
| Replication in host | None | Replicates | None |
| Adjuvant requirement | Typically required | Often not required | Typically required |
| Shedding / reversion risk | None | Possible | None |
| Sterile filtration | Not feasible due to particle size above 0.45 µm | Not applicable to final live cells | Feasible |
| Antigen spectrum | Whole bacterial cell | In vivo expressed antigens | Selected purified antigen or toxoid |
| Endotoxin burden | Higher | Variable | Lower |
| Storage | 2–8 °C liquid; lyophilized ≤2.0% moisture | Lyophilized cold chain | Refrigerated or lyophilized |
| Regulatory reference | USDA 9 CFR 113.70, Ph. Eur. 0362 | Live bacterial vaccine monograph | Specific purified antigen monograph |
Published data for direct replacement of whole-cell inactivated Pasteurella multocida with purified subunit antigens are limited and do not establish universal equivalence under field challenge. Formulators should verify adjuvant compatibility, dose-volume syringeability, and container-closure compatibility for each finished presentation. The API is not suitable for sterile filtration, and any terminal heat sterilization above 50 °C is contraindicated unless supported by specific antigen stability data.
