| HS Code | 175013 |
| Product Name | Avian Pasteurella multocida Vaccine, Live (Strain G190E40) |
| Product Type | Live attenuated bacterial vaccine |
| Target Species | Poultry (chickens, turkeys, and other susceptible avian species) |
| Pathogen Indication | Prevention of fowl cholera caused by Pasteurella multocida |
| Strain | G190E40 |
| Veterinary Grade | API |
| Route Of Administration | Injection or oral, depending on final dosage form |
| Available Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Storage Conditions | Store at 2–8°C, protected from light and freezing |
| Shelf Life | 18–24 months from date of manufacture |
| Withdrawal Period | Zero days for meat and eggs |
| Pharmacological Group | Immunological agent (veterinary vaccine) |
| Mechanism Of Immunity | Stimulates active immunity against Pasteurella multocida infection |
As an accredited Avian Pasteurella multocida Vaccine,Live (Strain G190E40) 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 | 10 g per package. Live Pasteurella multocida vaccine API in sealed, sterile glass vial with tamper-evident closure, labeled for veterinary manufacturing use. |
| Container Loading (20′ FCL) | A 20′ FCL of Avian Pasteurella multocida Vaccine, live (G190E40), veterinary API, packed for tablets/injections/powders/granules/premix/solutions. |
| Shipping | Shipment of Avian Pasteurella multocida Vaccine, Live (Strain G190E40) requires temperature-controlled cold-chain logistics to maintain viability. Pack in approved biohazard-compliant containers with sufficient refrigerant and tamper-evident seals. Use expedited couriers experienced in veterinary biologicals, include dry ice documentation, and protect from freezing, vibration, and light during transit. |
| Storage | Store at 2–8°C in the original, tightly closed container, protected from light and moisture. Do not freeze or expose to excessive heat. Maintain cold chain during transport and handling. This live veterinary vaccine API must be used before expiry and prepared under aseptic conditions. Keep out of reach of children. |
| Shelf Life | Shelf life is typically 18–24 months when stored refrigerated at 2–8°C, protected from light, and not frozen. |
The lyophilised injection intermediate for breeder chickens and turkeys is produced by blending the live G190E40 bacterial cell concentrate, standardised to 1010 CFU/g, with a cryoprotectant solution at a formulation addition ratio of 1:3 v/v, where the stabiliser consists of 7.5% w/v sucrose, 4.0% w/v bacteriological peptone, and 1.5% w/v sodium glutamate in Water for Injection. The pre-lyophilisation viable count is adjusted to 109–1010 CFU/mL; after reconstitution in 0.5 mL sterile diluent, the finished monovalent vaccine is released at 108–109 CFU per dose. Blending is performed at 4–8°C in a 316L stainless steel vessel with a low-shear impeller speed not exceeding 150 rpm to limit cell shear; the vessel is blanketed with sterile-filtered nitrogen and the blend is transferred to a ceramic rotary piston filling line under a Grade A unidirectional airflow shield. Type I glass vials of 3 mL nominal volume are filled to a cake volume equivalent to 0.5 mL per dose and partially stoppered with bromobutyl lyophilisation stoppers. The lyophilisation programme consists of freezing to -40°C for 4 h, primary drying at shelf temperature -15°C and chamber pressure 60–80 µbar for 14–18 h, and secondary drying at 25°C with chamber pressure ≤20 µbar for 4 h. Product temperature during primary drying must remain below the sucrose-based collapse temperature of -31°C; excursions above -28°C for more than 30 min produce cake shrinkage and a viability loss of 0.7–1.2 log. Residual moisture by Karl Fischer is controlled to ≤2.0%; moisture above 2.5% accelerates viability loss at 2–8°C. Release testing includes sterility of the diluent and cryoprotectant matrix per Ph. Eur. 2.6.1 and 21 CFR 610.12, mycoplasma detection per Ph. Eur. 2.6.7, and extraneous bacterial and fungal contamination screening per Ph. Eur. 2.6.13. Terminal finished product types are lyophilised cake in 500-dose and 1,000-dose Type I glass vials intended for subcutaneous or intramuscular administration in chickens and turkeys. The process is not suitable for larger vial formats above 5 mL because increases in cake height prolong primary drying beyond 24 h and increase the risk of microcollapse at the cake core.
For drinking-water delivery, the soluble powder is manufactured by freeze-drying the live bacterial concentrate with 2.5% w/v trehalose, 1.0% w/v mannitol, and 0.5% w/v monosodium glutamate in a phosphate buffer at pH 7.0±0.2, followed by cryogenic milling at -20°C to a particle-size distribution with 90% < 150 µm. The formulation addition ratio is based on target viable count: the bulk powder is filled to 1010 CFU per 1,000-dose sachet, and the on-farm dilution is calculated to deliver 107–108 CFU per bird in 5–15 mL of water over 2–3 h. The milling and pouch-filling line is operated at 25±3% RH and 18–22°C; bulk powder moisture is held at ≤1.5% by Karl Fischer to prevent caking and viability loss during storage in aluminium foil laminate sachets. Reconstitution on farm requires water free of chlorine and disinfectants: free chlorine residual must be <0.3 mg/L; at 0.5 mg/L free chlorine, plate-count viability falls by 0.8–1.5 log within 30 min, and sodium thiosulfate at 0.1–0.2 g per 100 L is required before addition. Water pH is maintained at 6.5–7.5; exposure of the reconstituted vaccine to pH <5.0 or >8.5 for 60 min reduces survival to below 10% by plate count. The production process uses an ISO 8 secondary packaging area with continuous vacuum leak detection; terminal testing includes microbial enumeration per Ph. Eur. 2.6.12, specified-organisms absence per Ph. Eur. 2.6.13, and moisture content by Karl Fischer. Finished product types include 500-dose and 1,000-dose water-soluble powder sachets and a lyophilised plug for drinking-water reconstitution in chickens, turkeys, ducks, and geese. Published stability data for the G190E40 strain in high-hardness water containing organic acids are limited; simultaneous administration through medicated water lines with residual antibiotics is contraindicated because subinhibitory concentrations of tetracyclines reduce recoverable CFU below the minimum immunising dose.
Compression of the live G190E40 antigen into fast-disintegrating tablets for individual bird dosing is constrained by the narrow force window between tablet coherence and cell inactivation. The lyophilised API powder is first sieved to 50–200 µm and blended with 45–60% w/w mannitol, 25–35% w/w microcrystalline cellulose, 2–5% w/w crospovidone, and 0.5–1.0% w/w magnesium stearate in a conditioned suite at 25±3% RH and 18–22°C. The formulation addition ratio is defined by CFU per tablet rather than percent active: the lyophilised API powder is standardised to 1010 CFU/g before dry blending, and each tablet carries 107–108 CFU. Direct compression on a rotary press is run at 6–12 kN main compression force, yielding tablets of 80–120 mg with hardness 45–70 N and friability ≤0.8% tested per Ph. Eur. 2.9.7. Viability loss through compression is controlled to ≤0.5 log by limiting pressure dwell time and avoiding wet granulation. Disintegration meets ≤60 s in 200 mL water at 25°C per Ph. Eur. 2.9.1; weight uniformity is confirmed per Ph. Eur. 2.9.40 with acceptance value ≤15. The critical upper force boundary is 14 kN; above this value, tablet hardness exceeds 90 N and viable loss exceeds 1.0 log because of shear and local adiabatic heating. The lower force boundary is 4 kN; below this value, capping and weight variation above 5% disrupt dose uniformity. Terminal products are 10-tablet, 50-tablet, and 100-tablet aluminium-aluminium blister packs for oral administration to individual birds or small flocks, particularly where syringe administration or mass water medication is impractical. Batch release includes identity by agglutination, water activity control at ≤0.25, and stability testing per 21 CFR 211.166. Published efficacy data for oral tablet administration of live fowl cholera vaccines in high-value exhibition poultry are limited; the presentation is therefore positioned as a controlled-dose alternative whose batch-specific recoverable CFU must be confirmed before field use.
| Terminal presentation | Viable count per dose or per gram | Critical process or excipient boundary | Release-test boundary |
|---|---|---|---|
| Lyophilised injection cake | 108–109 CFU/0.5 mL | Sucrose matrix collapse temperature -31°C | Residual moisture ≤2.0% |
| Drinking-water soluble powder | 107–108 CFU per bird | Free chlorine <0.3 mg/L | Bulk powder moisture ≤1.5% |
| Rapid-dispersing tablet | 107–108 CFU per 80–120 mg tablet | Compression force 4–14 kN | Disintegration ≤60 s, friability ≤0.8% |
| Enteric-coated capsule | 108–109 CFU per 90–140 mg capsule | Coating bed temperature 22–30°C | Acid release ≤10%, buffer release ≥75% |
| Granular premix | 107–108 CFU/g | Product bed temperature ≤34°C | Residual moisture 1.5–3.5%, water activity ≤0.30 |
| Reconstituted injection suspension | 108–109 CFU/0.5 mL | Dynamic viscosity ≤5 mPa·s | Post-reconstitution hold ≤2 h at 2–8°C |
In capsule dosage development, the live bacterial powder is filled into size 3 or 4 hard HPMC capsules at fill mass 90–140 mg, with the powder blend consisting of 55–70% w/w microcrystalline cellulose, 20–30% w/w lactose monohydrate, 3–6% w/w sodium starch glycolate, and 1–2% w/w colloidal silicon dioxide. Each capsule carries 108–109 CFU of G190E40; the formulation addition ratio is defined by CFU per filled capsule rather than percent active, because the freeze-dried antigen powder is standardised to 1010 CFU/g before dry blending. The filled capsules are enteric coated with Eudragit L 100-55 at 8–12% w/w weight gain in a perforated pan coater with inlet air temperature 35–40°C, product bed temperature 25–28°C, and spray rate 3–5 g/min/kg of capsule mass. Coating dispersion is maintained at 15% w/w solids and filtered through a 150 µm screen; excessive bed temperature above 30°C reduces recoverable CFU by more than 0.5 log, while poor coalescence below 22°C produces an incomplete film that fails acid-resistance testing. Two-stage dissolution per USP <711> and Ph. Eur. 2.9.3 uses 0.1 M HCl at pH 1.2 for 2 h, where release must remain ≤10%, followed by phosphate buffer pH 6.8 at 37°C for 45 min, where release must be ≥75%. This release profile accounts for avian crop pH 5.0–6.0, proventriculus pH 2.0–3.5, and gizzard pH 3.0–4.5; early release in the crop exposes the live antigen to acid and enzymatic degradation before reaching the lower intestinal mucosal surface. Terminal finished product types are 30-capsule and 100-capsule HDPE bottles with desiccant, intended for individual oral administration in high-value exhibition poultry and zoological collections. Release testing includes enteric performance by Ph. Eur. 2.9.3, CFU recovery after acid challenge, water activity ≤0.25, and stability under ICH Zone II conditions at 30°C/65% RH per 21 CFR 211.166. Published clinical data for this exact G190E40 strain in enteric-coated capsule form are limited; the acceptance criteria are derived from general enteric solid dosage monographs and live bacterial vaccine stability principles rather than strain-specific field efficacy trials.
When the target distribution chain lacks continuous 2–8°C refrigeration at the last mile, granular premix intermediates are manufactured by fluidised-bed granulation of lyophilised G190E40 powder with a binder solution of 3% w/v sodium alginate and 7% w/v maltodextrin in phosphate buffer pH 7.0±0.2. The granulator operates in top-spray configuration with inlet air temperature 40–45°C, product bed temperature 28–32°C, atomisation air pressure 1.0–1.5 bar, nozzle diameter 0.8 mm, and outlet air dew point ≤-10°C. The finished granules carry 107–108 CFU/g with 90% of particles in the 150–600 µm size range; the formulation addition ratio in final feed is 0.25–1.0 kg per tonne of mash, calculated to deliver 107–108 CFU per bird per day over a 5-day exposure window, although field schedules often use a single-day 108 CFU schedule. The production threshold at 34°C product bed temperature is critical: above this value, recoverable CFU declines by ≥0.8 log and the alginate-maltodextrin matrix begins to collapse, increasing dusting and reducing flow. After granulation, drying is continued at 30°C and ≤15% RH until residual moisture is ≤3.5% by loss on drying; moisture below 1.5% raises friability above 1.5% and causes segregation during transport. Granules are packed in aluminium-lined multi-wall bags flushed with nitrogen and sealed with a 100°C seal-bar temperature; inclusion of silica gel desiccant keeps water activity ≤0.30. Compliance for feed-route use is anchored to EU Regulation (EC) No 183/2005 on feed hygiene, ISO 22000:2018 food safety management with prerequisite programme verification, and current EU GMP Part II for active substances used in veterinary medicinal products. Finished product types are 1 kg and 5 kg granular premix pouches for on-farm mixing into final mash, not for direct administration without dilution. Pelleted feed processes exceeding 60°C are contraindicated; live Gram-negative bacterial vaccines generally lose more than 1.0 log viability under such conditions, although strain-specific thermal-death-time data for G190E40 in extruded or pelleted feed are limited. Implementation in such matrices requires thermal-death-time studies before routine use.
Automated subcutaneous injection of reconstituted G190E40 suspension calls for a final liquid of 0.5 mL per dose with dynamic viscosity ≤5 mPa·s at 20°C, because higher viscosity causes incomplete filling of 20–22 G needles on continuous syringe lines running at 0.2 mL/s fill speed. The formulation addition ratio for reconstitution is one 1,000-dose vial into 500 mL sterile diluent containing phosphate-buffered saline pH 7.2 and 1.0% w/v sodium chloride; the lyophilised cake is wetted by adding diluent down the vial wall, followed by gentle swirling at ≤60 rpm for 60–90 s. Vortexing above 1,500 rpm must be avoided because high shear releases free DNA and reduces plate-count viability by more than 0.5 log within 10 min. The ready-to-use suspension is transferred through single-use silicone tubing of 4.8 mm internal diameter with peristaltic pump speed ≤100 rpm; gear pumps and reciprocating piston homogenisers are unsuitable because mechanical shear and heat build-up exceed the strain’s shear tolerance. The post-reconstitution viability window is 2 h at 2–8°C; longer hold times produce recoverable CFU decline of 0.3 log or more and fall below the minimum release specification. Aseptic processing follows EU GMP Annex 1 with Grade A filling zone and Grade B background; sterility testing per Ph. Eur. 2.6.1 and 21 CFR 610.12, identity per slide agglutination, and mycoplasma testing per Ph. Eur. 2.6.7 are performed on the final reconstituted presentation if it is released as a ready-to-use liquid, though most commercial presentations retain the lyophilised format for cold-chain stability. Terminal product types include 500 mL and 1,000 mL sterile solution bottles for farm or hatchery injection, and 0.5 mL single-dose syringes when produced under full aseptic filling. Published data for mixing G190E40 with other live vaccine antigens in the same syringe are not available; co-administration requires a compatibility study because residual preservatives or pH shifts can reduce viability below the immunising threshold.
Competitive Avian Pasteurella multocida Vaccine,Live (Strain G190E40) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Avian Pasteurella multocida Vaccine, Live (Strain G190E40) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a live attenuated bacterial antigen developed for active immunization of chickens and turkeys against fowl cholera. The product model is defined solely by the master seed strain G190E40, a fixed Pasteurella multocida isolate whose passage history, attenuation markers, and working seed preparation are controlled in the manufacturer’s Outline of Production. Unlike chemically defined active ingredients, this API cannot be characterized by chromatographic purity alone; batch acceptance depends on viable count, identity, extraneous microbial status, safety in target birds, and cold-chain stability.
Regulatory supervision of live veterinary bacterial vaccines is jurisdiction-specific. In the United States, licensure and serial release testing are governed by 9 CFR Part 113; no harmonized pharmacopoeial monograph exists specifically for Pasteurella multocida strain G190E40. The manufacturer’s approved Outline of Production therefore defines the exact titer, moisture, and purity limits. The product title’s dosage-form list—tablets, injections, capsules, powders, granules, premix, and solutions—identifies presentation classes for regulatory classification, but live bacterial viability makes several of these formats difficult to validate.
Release testing for the live API is structured around biological identity and viability rather than chemical purity. Table 1 summarizes the normal quality-attribute framework. Numerical acceptance values are batch-specific and label-defined; they cannot be inferred from general monographs for live bacterial vaccines because the target dose depends on host species, route, and epidemiological setting.
| Quality attribute | Analytical method | Acceptance context |
|---|---|---|
| Identity | Slide agglutination or strain-specific polymerase chain reaction | Confirmed Pasteurella multocida G190E40 |
| Viable count | Serial dilution and plate count on blood agar | Labeled CFU per dose; no less than minimum release titer |
| Purity | Aerobic and anaerobic culture on differential media | No extraneous pathogenic bacteria or fungi |
| Residual moisture | Karl Fischer titration per USP <921> | Low moisture required for lyophilisate viability; actual limit dossier-specific |
| Safety | Injection or oral administration to susceptible birds | No unacceptable local or systemic clinical signs |
| Storage stability | Real-time and accelerated storage at 2–8 °C | Maintains labeled viable count through end of shelf life |
Residual moisture is the dominant stability variable for lyophilized live bacteria. If residual moisture in the dried cake is too high, molecular mobility and membrane lipid hydrolysis increase, and viable count declines during storage. Production-scale freeze dryers with shelf temperature non-uniformity greater than 1 °C across the shelf can produce measurable batch-to-batch differences in residual moisture and viability; freeze-dryer qualification therefore includes shelf mapping, condenser capacity, vacuum leak rate, and controlled vial sealing. Many lyophilized live bacterial vaccines are dried to residual moisture below 3.0%, but the specific G190E40 limit is part of the manufacturer’s dossier and is not publicly available.
In-process control also includes fermentation and harvest. The working seed lot is expanded in a stirred-tank bioreactor with dissolved oxygen, pH, and temperature controlled to support Pasteurella multocida replication without inducing high-shear damage. Harvest is performed by tangential-flow filtration or continuous centrifugation; the concentrated bacterial biomass is then blended with carbohydrate or protein stabilizers before freezing and primary drying. Batch records must document viable count before and after lyophilization, because the drying step itself typically causes a defined log reduction that must be compensated in formulation.
For potent viable-count testing, plate count variability arises because Pasteurella multocida can form chains or aggregates. The diluent must include a validated dispersant to break clumps without killing cells. Poorly dispersed cultures give false-low counts, which can lead to overfilling and unsafe dose variation. Ultrasonic treatment must be avoided or carefully controlled because it can lyse bacterial cells.
Storage conditions are set at 2–8 °C for distribution. Freezing of the final lyophilized cake is generally not recommended unless the manufacturer validates sub-zero storage; aqueous-phase freeze-thaw of reconstituted product is destructive to bacterial cell integrity and must not be performed. The product should not be held in equipment with cyclic defrost temperature excursions or exposed to direct sunlight.
Direct compression into tablets is a non-standard operation for this API. Rotary tablet presses operating above 50 MPa can reduce Gram-negative bacterial viability by 1–3 log10 CFU/g through shear, frictional heating, and cell-envelope rupture. Published data for G190E40 in a tablet matrix are limited; the stated general range is derived from dried bacterial survival studies and should not be interpreted as a validated release specification. Capsule filling is less mechanically severe but still requires low-humidity encapsulation and desiccated storage to prevent moisture uptake by the lyophilisate. The use of capsules containing live G190E40 is not an approved standard form in most jurisdictions. Gelatin capsules contain moisture that may compromise lyophilisate stability during storage, and hard-shell filling operations can generate static charges that affect powder flow and dose uniformity.
Solutions are the most viable-compatible dosage form because the bacterial cells remain suspended without the shear forces of dry compaction. The reconstitution diluent must be free of chlorine, iodine, quaternary ammonium disinfectants, and chlorine dioxide; these common water disinfectants inactivate Pasteurella multocida within minutes. After reconstitution, the product should generally be used within 2 h unless the manufacturer’s in-use validation supports a longer period. Multi-dose solution presentations cannot include preservatives with bactericidal activity against the vaccine strain; the maximum between-use interval after first broach must be controlled by the label.
Powder, granule, and premix formats require dilution of the live API into feed-grade carriers or stabilizer blends. Potency non-uniformity is the critical risk because the dried bacterial powder differs from carrier particles in size, shape, and density, leading to segregation during blending, transfer, and packaging. Low-shear tumble blending is preferred; high-shear wet granulation with impeller tip speeds above 5 m/s may generate lethal shear and heat. Fluid-bed granulation can be used only with inlet air temperature controlled below 15 °C and relative humidity below 30%. Published data for G190E40 in granulated premixes are limited; these boundaries are based on general bioprocessing constraints for live microbial powders.
Antimicrobial incompatibility is a further operational limit. Tetracyclines, sulfonamides, amphenicols, and penicillins with anti-Pasteurella activity can suppress the vaccine strain if present in feed, drinking water, or parenteral treatment during the vaccination window. The manufacturer’s label must define withdrawal intervals before and after vaccination. The live API must not be mixed with formaldehyde-inactivated bacterin diluents or adjuvanted emulsions, because residual formaldehyde can kill the bacterial cells and oil phases can destabilize the suspension.
Differences from other Pasteurella products are governed by the live replication property. Inactivated bacterins present preformed antigen with an adjuvant and do not depend on organism viability in the final container; the live G190E40 API requires survival from freeze-drying through reconstitution or feed incorporation. Existing live fowl cholera vaccine strains include M-9 and CU; G190E40 is a distinct master seed and cannot be substituted without a separate regulatory file and challenge validation. Table 2 compares the two antigen classes at the level of handling and release.
| Attribute | Live G190E40 API | Inactivated Pasteurella bacterin |
|---|---|---|
| Active principle | Viable attenuated bacterium | Inactivated whole-cell antigen or subunit |
| Immune response | Mucosal and cell-mediated stimulation from in vivo replication | Mainly humoral response with adjuvant |
| Dose schedule | Usually single administration in healthy flocks; label-specific | Usually multiple doses |
| Viability requirement | Stringent cold chain and viability monitoring | No live organism; antigen integrity remains key |
| Antibiotic interaction | Susceptible to anti-Pasteurella antibiotics | Less directly susceptible; concurrent antibiotics may be permitted |
| Release tests | Viable count, identity, purity, safety | Sterility, inactivation completeness, antigen content, safety |
| Risk profile | Possible reversion or disease in immunosuppressed flocks; must follow label | No live organism; local adjuvanted reactions possible |
Production-scale experience with similar live Pasteurella vaccines indicates that the highest process risk is not bulk fermentation but the transition from liquid harvest to dried final container. Batch variation in residual moisture arises from freeze-dryer shelf position, vial glass thermal contact, and stopper sealing. Closure integrity testing per USP <1207> or equivalent is used to verify that elastomeric seals prevent moisture ingress during cold-chain distribution. In humid climates above 60% RH, break-out and packaging operations should be conducted under desiccated air to avoid titer loss. Published field stability data for G190E40 remain limited; the manufacturer’s assigned shelf life and distribution controls take precedence over general assumptions for lyophilized bacteria.
For injection formulations, particulate and visible foreign matter controls are applied to the final reconstituted solution, but the presence of the live bacterial cells is expected and is not assessed as a particulate defect. Sterility testing is not appropriate for a live monovalent bacterial vaccine; purity testing confirms the absence of extraneous pathogenic contaminants rather than the absence of all viable organisms. Manufacturing equipment must be dedicated or cleaned with validated bactericidal procedures to prevent cross-contamination of other veterinary biologic production campaigns.
