| HS Code | 418889 |
| Product Name | Anthrax Vaccine Veterinary Grade API |
| Api Name | Bacillus anthracis (Sterne strain) live spores |
| Grade | Veterinary Grade |
| Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Indications | Active immunization of animals against anthrax |
| Target Species | Cattle, sheep, goats, pigs, horses |
| Route Of Administration | Subcutaneous or intramuscular depending on formulation |
| Storage Conditions | Store at 2-8°C, protected from light |
| Ph Range | 6.5-7.5 |
| Adjuvant | Saponin or aluminum hydroxide formulation dependent |
| Preservative | Formaldehyde or thiomersal-free formulation dependent |
| Appearance | Off-white to light brown suspension or lyophilized powder |
| Shelf Life | 24 months under recommended storage conditions |
As an accredited Anthrax 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 | Supplied in sealed, light-resistant, tamper-evident containers suitable for sterile handling. Quantity: 100 g of veterinary-grade Anthrax Vaccine API per container. |
| Container Loading (20′ FCL) | 20′ FCL: palletized, sealed drums/containers of Anthrax Vaccine API, temperature-controlled, hazard-labeled, secured with bracing, no co-loading with feed. |
| Shipping | Shipped as a regulated veterinary biological under applicable dangerous-goods rules, with temperature-controlled packaging (typically 2–8°C), triple leak-proof containment, and clear hazardous-material labeling. Export/import permits, safety data sheets, and cold-chain monitoring documentation accompany delivery. Transport is via licensed couriers with full tracking and customs clearance support. |
| Storage | Store at 2–8°C in the original, tightly sealed container, protected from light and moisture. Do not freeze. Keep in a well-ventilated area, away from heat sources and incompatible substances. For powders and granules, ensure dry conditions; for solutions and premixes, avoid contamination. Follow veterinary-specific handling guidelines and use before expiry. |
| Shelf Life | Shelf life: 24 months when stored at 2–8°C, protected from light, in airtight containers. |
Downstream formulation of Anthrax Vaccine Veterinary Grade API begins with the viable spore concentrate of Bacillus anthracis Sterne 34F2, a pXO1+/pXO2− production strain. In aqueous injectable manufacture, the API is standardized by plate count on blood agar or equivalent selective medium before blending with a saponin adjuvant in phosphate-buffered saline. The assembled suspension is targeted to a release titre of 1×106–5×107 CFU per 1 mL dose for cattle and horses, with smaller ruminant doses reduced to 0.5 mL according to national label directions. Homogenization is performed in a closed stainless-steel vessel with a top-entry agitator at 80–150 rpm; higher shear rates are avoided because spore chain disruption can alter sedimentation behavior in the finished vial. Sterility of the surrounding vehicle is confirmed by membrane filtration of the saponin-saline solution prior to spore addition. The final suspension is released by purity and identity requirements under 9 CFR 113.68 and the WOAH Terrestrial Manual chapter 3.1.1. Cold storage at 2–8°C is required because any vegetative cell carryover can reduce pH and accelerate loss of germination inhibition. The dominant production bottleneck is settle-out during filling: without continuous low-shear recirculation through a peristaltic pump at 10–20 L/h, the coefficient of variation for dose titre across a 5,000-vial campaign can exceed 15–25%. Finished vials are stoppered under nitrogen to limit oxidative saponin degradation. The package insert carries a withdrawal period statement where the national competent authority requires one. Published data for specific injectable spore formulations remain limited; the release titre and adjuvant ratio are fixed by the product regulatory file rather than a universal pharmacopoeial monograph.
Lyophilized tablet and powder presentations are manufactured when the injectable suspension is converted to a dry, reconstitutable format for remote field vaccination kits. The drying cycle is assigned on a per-lyophilizer basis because the spore concentrate contains residual sodium chloride and growth-medium solids. Freeze-drying microscopy of the formulated spore suspension typically identifies a collapse temperature between -28°C and -22°C; primary drying is therefore held at product temperature below -25°C with shelf ramp rates not exceeding 0.5°C/min. A shelf freeze dryer with a condenser capacity of at least 15 kg per 24 h and a chamber pressure of 50–150 µbar is commonly employed. After primary drying, the product is held at 25–30°C for secondary drying until residual moisture by Karl Fischer titration under USP 921 method 1c is below 3.0%. The dried cake or compacted tablet must reconstitute within 60 s when shaken with sterile diluent at 20°C. Production-scale batches show that tablets compressed from lyophilized powder at 10–15 kN using a rotary press can retain viable spore counts above 90% of the predry titre when the press tooling is cooled to 2–8°C. Failure modes observed on manufacturing lines include cracked tablets due to over-drying below 1.0% moisture and prolonged reconstitution caused by collapse in the vial bottom. Because the API is a live spore, terminal sterilization cannot be applied; the entire fill and freeze-drying train is maintained under aseptic conditions. Residual moisture can be verified only by destructive testing, so moisture sorption isotherms for the tray-loaded batch are generated at 10%, 20%, and 30% RH to assign a safe secondary drying endpoint. Published data for veterinary anthrax spore vaccine tablets are limited, and each filling line requires cycle qualification against actual tray load geometry rather than a fixed universal recipe.
Oral capsule and tablet dosage forms for this API are not the dominant licensing route, and published data for commercial wildlife oral anthrax vaccine tablets are limited. Where an oral bait format is evaluated, spore survival in the gastrointestinal tract is the critical parameter: the capsule or tablet must incorporate a pH-sensitive enteric polymer such as cellulose acetate phthalate or methacrylic acid copolymer type C to delay release until the small intestine. Tableting of live spores is conducted as a direct compression or dry granulation process because aqueous wet granulation can initiate premature germination. The compression force is held below 80 MPa to limit frictional heating above 30°C. Sieve cuts of granules are selected between 500 µm and 1.0 mm for bait pellets. No commercial monograph equivalent to 9 CFR 113.68 exists for oral anthrax vaccine in most jurisdictions; therefore regulatory acceptance relies on a case-by-case demonstration of efficacy and target-animal safety. The most significant production barrier is the moisture vapour transmission rate of the capsule shell: hard gelatin capsules equilibrate at 10–13% residual moisture at 40% RH, which may be compatible with spore stability, while HPMC capsules equilibrate at 4–8% moisture and provide better compatibility with low-moisture desiccated packaging. Operators report that electrostatic charging during high-speed encapsulator operation causes API dust adhesion to contact parts; humidity above 45% RH reduces charge accumulation but raises moisture ingress. The process is therefore run at 35–40% RH with ionizing bars positioned over the capsule transport track. Coating pans used for enteric coating are operated with inlet air at 40°C and pan speed between 8–12 rpm, because higher inlet temperatures can reduce spore viability by more than 1 log₁₀ in a single coating pass.
Granular and premix applications for the API in livestock feed or mineral supplements require blending of the spore concentrate with dry carriers at low addition rates, typically 0.1–1.0% w/w of total mix. The API is first spray-dried or lyophilized onto a carrier such as lactose monohydrate or microcrystalline cellulose with a particle size range of 125–250 µm. The resulting intermediate is passed through a conical mill at 1,000–1,500 rpm using a 0.5 mm screen to break agglomerates. In a ribbon blender or V-blender, fill volume is maintained at 50–65% of rated capacity and mixing time is set between 10–20 min after homogeneity testing of a riboflavin tracer. Viable spore recovery after blending is verified by plate count on polymyxin-lysozyme-EDTA-thallous acetate agar; losses of 0.5–1.0 log₁₀ are common when dry blending exceeds 25 min. Segregation during bulk transport is controlled by matching bulk density of the carrier blend to the API intermediate within 0.15 g/cm³. Final premix is packaged in foil-lined bags at ≤10% RH and stored at 2–8°C. The greatest process obstacle in mineral premix lines is dust generation during bag unloading: a ventilated transfer shoe with a dust extraction capture velocity of 15–20 m/s is required to prevent spore carryover into ambient air. Blend uniformity for the premix is monitored by sampling at 10 defined points across the blender shell; the relative standard deviation of spore titres after validated mixing should remain below 10%. Published data for specific granular spore vaccines in commercial feed use are limited, so release specifications are derived from the biological master file rather than a harmonized pharmacopoeial standard.
Ready-to-use liquid presentations are formulated as a resuspended spore concentrate in a multidose polypropylene or glass container, intended for automated syringe or needle-free injection equipment. The particle burden of the API imposes a nozzle diameter of at least 0.6 mm to avoid occlusion in pneumatic injection guns. Fill volume per dose is commonly set at 0.5 mL or 1.0 mL, and the fill line is run with periodic weight checks every 15 min. The liquid must be agitated with a magnetic stir bar or slow-speed impeller before and during filling because spore sedimentation follows Stokes’ law; for a 1.5 µm spore with density near 1.1 g/cm³ in saline, calculated settling velocity is approximately 0.02–0.05 mm/min, but aggregate formation can raise it tenfold. Therefore fill lines are configured with recirculation loops and baffled vessels. Saponin hemolysis testing is included in finished-product release because free saponin can lyse red blood cells if overdosed; the limit is defined by the individual licensing authority rather than a universal monograph. Sterility testing of the final spore suspension cannot use conventional terminal sterilization because the API is a live spore; all process steps after spore addition are aseptic. Operators observe that the stainless-steel impeller shaft creates a vortex if speed exceeds 150 rpm, entraining air and causing foaming that destabilizes the saponin; the shaft is therefore fitted with a baffle ring. In automated injection lines, sustained pump shear above 300 s−1 can increase the proportion of unsettleable aggregates, so lobe pumps with low clearance are de-rated to avoid spore chain breakage.
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Anthrax Vaccine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is presented as a live-spore antigen concentrate derived from Bacillus anthracis Sterne 34F2, designated model AVV-34F2-SC. The strain is nonencapsulated because of the absence of the pXO2 plasmid, while retention of pXO1 permits expression of protective antigen, edema factor, and lethal factor proteins required for immunogenicity. The API is intended solely for incorporation into licensed veterinary biological products; it is not a finished immunogen and is not appropriate for human use. In contrast to human anthrax vaccine adsorbed, which is an acellular protective-antigen filtrate, the veterinary Sterne 34F2 concentrate relies on controlled germination and toxin expression in the vaccinated animal. Typical liquid concentrate holds 1.0 × 10⁹–1.0 × 10¹⁰ CFU/mL, with pH 6.0–7.2 and spore Dv50 0.8–1.5 µm. The product supports aqueous injection as the primary route recognized under USDA 9 CFR 113.65 and the OIE Terrestrial Manual anthrax chapter. Tablet, capsule, powder, granule, premix, and solution presentations require separate formulation development because spore viability, rather than simple chemical stability, governs shelf life and dose uniformity.
In a production-scale veterinary biological line, the concentrate is typically transferred from a 50 L frozen stock through a 0.22 µm vent filter to a 1000 L cGMP mixing vessel. Because Sterne 34F2 spores are not filter-sterilizable, aseptic process assurance depends on pre-sterilized components and environmental controls rather than terminal filtration. Frozen storage at -70 °C preserves viability for 24 months, while liquid refrigerated storage at 2–8 °C is limited to 6 months unless stability data support extension. Batch-to-batch variation in spore count should be controlled within ±0.3 log₁₀ CFU/mL to avoid subpotent or excessively reactogenic fill volumes. This variation is monitored by spread-plate enumeration on polymyxin–lysozyme–EDTA–thallous acetate agar after heat inactivation of vegetative cells at 65 °C for 30 min.
The Sterne 34F2 spore concentrate differs from conventional antibiotic APIs used in premixes because process temperature, shear, moisture, and oxygen exposure directly alter viable count. For dry powder and granule conversion, the main operational boundary is product temperature below 35 °C during drying, because Bacillus anthracis spores are resistant to desiccation but susceptible to germination at elevated water activity and temperature. A fluid-bed dryer with inlet air dew point lower than -20 °C and product temperature capped at 35 °C is used to avoid wet-bulb excursions. Lyophilized API should carry residual moisture below 5.0% by Karl Fischer titration and should be blended under relative humidity below 30% to prevent premature germination. Direct compression of spore concentrate into tablets at compaction pressures above 80 MPa can reduce viable count by more than 1.0 log₁₀ CFU; published data for this specific configuration is limited. Consequently, tablets and capsules are not currently recognized as standard anthrax vaccine presentations under 9 CFR 113.65, and any such dosage form must be validated for spore survival, blend homogeneity, and dissolution of the carrier matrix before field use.
For injectable finished products, the API is diluted in sterile 0.9% w/v sodium chloride or a proprietary veterinary diluent to a target dose of 1.0 × 10⁶–1.0 × 10⁷ CFU per animal, depending on species and label claim. Terminal sterilization is incompatible; spores are heat-resistant but the suspending medium and container-closure integrity require aseptic processing or gamma irradiation of packaging components. Sterile filtration cannot be used because spore dimensions exceed 0.2 µm. Vial filling under ISO 7 or better is required, with a maximum fill temperature of 20 °C to avoid germination in aqueous media. Subcutaneous administration in cattle and goats is the most documented veterinary use; intramuscular injection of live spore vaccines is generally avoided because of local granuloma formation and potential for toxin-associated inflammation. This is a key difference from killed or acellular veterinary vaccines, which can be formulated with aluminum adjuvants and intramuscular administration with less risk of local spore persistence.
The release specification is not equivalent to a finished dose label claim; it defines the input material that downstream formulators must verify before wet granulation, lyophilization, or solution filling. The matrix below summarizes the typical release controls for the liquid or lyophilized concentrate.
| Parameter | Test method | Release limit |
|---|---|---|
| Identity, pXO1 retention | Multiplex PCR | pXO1 positive |
| Identity, pXO2 absence | Multiplex PCR | pXO2 negative |
| Viable spore count | Heat-shock plate enumeration on selective agar, 37 °C, 48 h | 1.0 × 10⁹–1.0 × 10¹⁰ CFU/mL |
| pH | USP <791> | 6.0–7.2 |
| Residual moisture, lyophilized | Karl Fischer titration, USP <921> Method Ia | ≤ 5.0% |
| Capsule-forming revertants | Bicarbonate agar colony morphology | 0 CFU in 1.0 × 10⁷ spores |
| Sterility | USP <71> | No growth |
Comparative distinction from other anthrax vaccine APIs is based on three molecular and process characteristics. First, Sterne 34F2 is pXO1-positive and pXO2-negative; the absence of pXO2 prevents capsule synthesis, so the organism is less likely to establish systemic replication in immunocompetent animals, while pXO1 supports protective antigen and immunogenic toxin expression. Second, the API is a live spore concentrate, not an inactivated culture supernatant or precipitated toxoid. This distinction matters because live spore viability after formulation must be confirmed by plate count, whereas killed or acellular anthrax vaccines are evaluated for antigen mass by immunoassay. Third, the Sterne 34F2 API is not aluminum-adsorbed at release; adjuvanted injectable products may be formulated downstream, but the concentrate itself remains a low-adjuvant, low-endotoxin biological. Human anthrax vaccine adsorbed, by contrast, is an aluminum hydroxide-adsorbed filtrate of a toxigenic nonencapsulated strain and is not interchangeable with veterinary live-spore API under FDA 21 CFR 601.2 or 9 CFR 113.65. Older Pasteur-type veterinary spore vaccines have a different attenuation history and are not considered equivalent in cross-protection studies; no pharmacopoeial interchangeability exists.
When injectable suspension replaces tablet compression for farrowing or feedlot herd immunization, the critical operational difference is not antigen potency loss but homogeneity during large-volume mixing. A 1000 L stainless-steel mixing vessel with bottom-mounted magnetic impeller operating at 150 rpm can maintain a spore suspension coefficient of variation below 5% over 60 min; however, settling of spores with Dv50 0.8–1.5 µm is slow but not negligible after 4 h without agitation. Multi-dose vials therefore require continuous gentle mixing or pre-use agitation. The product should not be combined with antimicrobials, especially penicillin and tetracyclines, because these agents suppress germination and reduce the immune stimulus. Concurrent use of anti-inflammatory doses of dexamethasone should be avoided in the first 72 h after vaccination. In feedlot settings, needle-free jet injection has been evaluated but is not a standard method under 9 CFR 113.65; published comparative data for needle-free delivery of live anthrax spores is limited.
Granules and premixes for oral administration are not a substitute for parenteral immunization unless a specific mucosal challenge model supports local protective immunity. Published data for oral anthrax spore vaccines in ruminants remains sparse, and no current USDA-licensed oral anthrax vaccine exists in the United States. If a premix is prepared, the carrier should be a non-antimicrobial, low-dust cracked corn or soy hull with pH 6.0–7.0 and moisture below 12%. Mineral blend premixes containing high levels of calcium oxide or monocalcium phosphate can raise the local pH above 8.0, which may alter spore germination kinetics and should be avoided without compatibility testing. Because the API is a live biological, cleaning validation for production equipment after dry blending requires spore swab recovery and should include a decontamination step using sporicidal disinfectant validated for Bacillus spores.
Cross-form conversion is therefore governed by process stability rather than by simple chemical compatibility. The table below summarizes the control parameters that differ between dosage forms at pilot scale.
| Dosage form | Process-critical parameter | Documented operational boundary | Regulatory or technical basis |
|---|---|---|---|
| Injectable solution | Spore settling, aqueous germination | Fill temperature ≤ 20 °C; continuous mixing | 9 CFR 113.65 recognized route |
| Tablet | Compaction pressure, carrier hygroscopicity | Compression ≤ 80 MPa; RH ≤ 30% | Published data limited |
| Capsule | Fill uniformity, gastric degradation | Enteric coating required if oral challenge | Published data limited |
| Powder or granule | Drying temperature, residual moisture | Product temperature ≤ 35 °C; moisture ≤ 5.0% | Spore desiccation tolerance |
| Premix | Feed matrix pH, antimicrobial carriers | pH 6.0–7.0; avoid antimicrobial carriers | Oral route not compendial |
| Solution | Diluent pH, oxidizers | pH 6.0–7.2; avoid oxidizing agents | USP <791> |
Quality control release testing for the API is divided into identity, purity, viability, and batch consistency. Identity is confirmed by pXO1/pXO2 multiplex PCR and by colony morphology on sheep blood agar after 18–24 h at 37 °C in 5% CO₂. Purity is evaluated by absence of capsule-forming revertants on bicarbonate agar and by absence of fungal, yeast, and extraneous bacterial growth in sterility media. Viability is determined by heat-shock enumeration at 65 °C for 30 min, followed by dilution and plating on selective agar. Batch consistency requires that the spore count from three independent frozen final containers agree within ±0.3 log₁₀ CFU/mL. These methods are intended to be used in conjunction with the veterinary product license and not as standalone food or feed specifications.
Cold-chain failure is a primary operational risk. Lyophilized spore API stored at 2–8 °C is less sensitive to brief excursions than liquid spore suspension, but repeated freeze-thaw cycles of liquid concentrate damage spore coat integrity and reduce viable count by 0.5–1.0 log₁₀ CFU/mL per cycle. Shipping containers should use validated insulated packaging with data logger placement per WHO/IVB/11.10 or equivalent. At the receiving facility, a rapid plate count should be checked against the certificate of analysis before release to wet granulation or lyophilization. Product that has been exposed to temperatures above 25 °C for more than 72 h should not be used for sterile injectable manufacture, because germination in non-sterile diluents can increase bioburden. These boundaries apply equally to powders, granules, and premixes, but the moisture ingress risk is largest for premix blending in open mixer equipment.
The operational boundary that most separates this API from other veterinary vaccine APIs is its incompatibility with terminal sterilization and with antimicrobial premixes. Because live spores must survive desiccation, freezing, compression, or feed-matrix blending, each lot must be assayed for viable count after final formulation, not before. Final product labeling under 9 CFR 113.65 generally includes a re-vaccination interval of 12 months in endemic areas. Use of this API in non-ruminant species or by injection routes other than subcutaneous requires safety and efficacy data. Published data for oral tablet and capsule administration of live anthrax spores in cattle remains insufficient for compendial recognition. Therefore, those presentations are investigational and must be manufactured under a separate regulatory submission.
