| HS Code | 309133 |
| Product Name | Swine Epidemic Encephalitis Vaccine, Live Veterinary Grade API |
| Product Type | Live attenuated viral vaccine |
| Active Ingredient | Live attenuated swine epidemic encephalitis virus strain |
| Veterinary Grade | Veterinary grade API for animal pharmaceutical manufacturing |
| Target Species | Swine (pigs) |
| Indications | Active immunization of pigs against swine epidemic encephalitis to reduce viremia and prevent encephalitis |
| Api Dosage Form Compatibility | Suitable for formulation into tablets, injections, capsules, powders, granules, premix, and solutions |
| Route Of Administration | Intramuscular, subcutaneous, or as per final formulated vaccine product instructions |
| Storage Conditions | Store and transport refrigerated at 2°C to 8°C; protect from light and freezing |
| Shelf Life | Typically 12 to 24 months depending on final formulation and storage conditions |
| Quality Standard | Complies with veterinary pharmacopoeia standards for live viral vaccines |
| Withdrawal Period | Zero days withdrawal period for swine when used according to label directions |
As an accredited Swine Epidemic Encephalitis Vaccine,Live 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 | Swine Epidemic Encephalitis Vaccine, Live veterinary grade API is packed in 100 g sealed bottles, 10 bottles per carton. |
| Container Loading (20′ FCL) | 20′ FCL loading of live swine epidemic encephalitis vaccine API requires temperature-controlled transport, secure palletization, and proper segregation of dosage forms. |
| Shipping | Shipment requires strict cold-chain handling to maintain vaccine viability. Pack in insulated containers with validated coolants or dry ice, per IATA/ADR regulations. Use temperature loggers, leak-proof primary packaging, and biohazard labels. Include veterinary grade documentation and customs permits. Ensure rapid transit, continuous monitoring, and tamper-evident sealing for powders, liquids, and premix forms. |
| Storage | Store at 2–8°C in a refrigerator, protected from light and moisture. Do not freeze, as this may reduce vaccine potency. Keep in original, tightly sealed containers, away from heat sources and disinfectants. Ensure proper cold-chain handling during transport and storage to maintain efficacy for all downstream formulations. |
| Shelf Life | Store refrigerated at 2–8°C, protected from light. Typical shelf life is 12 months from manufacture; do not freeze. |
Bulk live swine epidemic encephalitis virus harvest concentrated by tangential flow filtration is supplied as a frozen intermediate at −70 °C in 2 L single-use ethylene vinyl acetate bags. The potency-adjusted working dilution after thawing is 1:50 to 1:200 of concentrated bulk, with cryoprotectant addition consisting of sucrose 4.0–6.0% w/v and bovine serum albumin 0.5% w/v before rate-controlled freezing; unprotected diafiltered harvest loses 0.3–0.8 log10 TCID50 per freeze–thaw cycle. Thawing is performed in a circulating water bath at 37 °C for 12–15 min with 30 rpm bag agitation, followed by immediate transfer to 4 °C stainless steel holding tanks. The thawed intermediate is clarified by depth filtration through 0.45 μm polyethersulfone capsules, then diafiltered against 10 mM potassium phosphate buffer pH 7.4 using 500 kDa tangential flow filtration cassettes. In-process virus titre is monitored by TCID50 on BHK-21 cells per Ph. Eur. 5.2.6; endotoxin release limit is 2.5 EU/mL per Ph. Eur. 2.6.14. The frozen intermediate complies with EU GMP Annex 2 for biological active substances and 21 CFR 600.15 for temperature maintenance during shipment; shipping qualification is performed in a calibrated −70 °C dry ice container for 72 h. The terminal product type is a frozen bulk live vaccine intermediate intended for downstream lyophilization or aqueous filling; it is not a finished dose form.
Aseptic filling of live swine epidemic encephalitis vaccine as a ready-to-use aqueous suspension is performed in Grade A unidirectional airflow over a Grade B background, with sterility release per Ph. Eur. 2.6.1 and 21 CFR 610.12. The formulation addition ratio is potency-adjusted: concentrated live virus bulk at 0.5–1.5% v/v is diluted into a vehicle containing hydrolyzed gelatin 1.0–2.5% w/v, sorbitol 2.0% w/v, and 10 mM potassium phosphate buffer pH 7.4; the target fill volume is 2.0 mL per dose to deliver 103.5 TCID50. Mixing occurs in a jacketed stainless steel vessel at 2–8 °C with 80–120 rpm impeller speed and nitrogen overlay at 0.2 bar positive pressure; the suspension is transferred through platinum-cured silicone tubing to a rotary piston pump filling line with fill accuracy ±1%. During filling, the bulk is maintained in a recirculating low-shear loop with a magnetic-driven impeller at 60 rpm to prevent sedimentation of virus–stabilizer complexes; fill volume is verified by in-line mass check every 5 min. Batch-to-batch variance in harvest titre requires potency reassay after compounding and before filling; a release window of ±0.3 log10 TCID50 against target is applied. The vials are stoppered, crimped, and held at 2–8 °C until release. Mycoplasma testing is performed per Ph. Eur. 2.6.7, and bacterial endotoxin limit is 2.5 EU/mL per Ph. Eur. 2.6.14. The terminal product is a ready-to-use aqueous parenteral suspension in 10-dose Type I glass vials with bromobutyl stoppers; because live virus titre decays at 25 °C by 0.3 log10 TCID50 over 14 days, cold-chain storage at 2–8 °C is mandatory.
Lyophilized injection of live swine epidemic encephalitis vaccine is formulated with a stabilizing matrix because live virus infectivity is not retained in simple saline cakes. The addition ratio for the lyophilization feed is 5.0–15.0% v/v live virus bulk, sucrose 4.0–6.0% w/v, mannitol 2.0% w/v, glycine 1.0% w/v, and potassium phosphate 0.5% w/v, filled at 2.0 mL into 5 mL Type I glass vials. Thermal characterization by differential scanning calorimetry gives a collapse temperature of −28 °C; the freeze-dry cycle ramps shelves from 5 °C to −45 °C at −0.8 °C/min, holds 3 h, primary drying shelf at −25 °C and chamber pressure 100 μbar for 18–20 h, then secondary drying at 28 °C for 6 h. Residual moisture is determined by Karl Fischer titration per Ph. Eur. 2.5.12 with a release limit of ≤3.0% w/w; cake appearance is assessed as white to off-white plug without shrinkage. Sterility release follows Ph. Eur. 2.6.1, mycoplasma testing follows Ph. Eur. 2.6.7, and virus titre follows Ph. Eur. 5.2.6. The terminal product is a lyophilized powder in a Type I glass vial sealed with 13 mm bromobutyl stopper; the product is reconstituted with 2.0 mL sterile diluent to a final dose.
| Stabilizer composition | Collapse temperature | Karl Fischer moisture | Reconstitution time |
|---|---|---|---|
| 4.0% sucrose / 2.0% mannitol / 1.0% glycine | −29 °C | 2.7% w/w | 110 s |
| 5.0% sucrose / 2.0% mannitol / 1.0% glycine | −28 °C | 2.2% w/w | 90 s |
| 6.0% sucrose / 3.0% mannitol / 0.5% glycine | −27 °C | 1.8% w/w | 75 s |
The reconstitution diluent supplied with lyophilized live swine epidemic encephalitis vaccine is formulated as a low-extractable isotonic vehicle because phosphate-buffered saline alone depresses viral infectivity titre by 0.2 log10 TCID50 within 30 min when residual aluminum ions exceed 10 μg/L. The addition ratio for the diluent is sodium chloride 0.85% w/v, potassium dihydrogen phosphate 0.06% w/v, polysorbate 80 0.02% w/v, and water for injections q.s.; no live virus is added. The solution is prepared in a 316L stainless steel tank, filtered through 0.22 μm PVDF, filled into 5 mL glass ampoules under Grade A air, and terminally sterilized at 121 °C for 15 min. Depyrogenation of ampoules is performed at 250 °C for 45 min; bacterial endotoxin limit is 0.25 EU/mL per Ph. Eur. 2.6.14. Container closure integrity is verified by dye ingress per Ph. Eur. 3.2.9 after terminal sterilization. The terminal product is a co-packed sterile diluent ampoule or blow-fill-seal ampoule, used to reconstitute 2.0 mL lyophilized cake to a final vaccine dose.
Combination of live swine epidemic encephalitis virus with other live porcine viral bulks is not a simple co-lyophilization step because virus–virus interference, most commonly via interferon induction, can suppress the potency of one component by more than 1.0 log10 TCID50. In polyvalent development, the live swine encephalitis component is potency-adjusted to 104.0 TCID50 per dose and combined with the second attenuated viral bulk at 1:1 to 1:3 potency-adjusted volume ratios; the shared stabilizer remains sucrose 5.0% w/v, hydrolyzed gelatin 1.5% w/v, and potassium phosphate 0.5% w/v. Blending is performed at 4 °C in a sterile single-use bag with 50 rpm impeller for 15 min; pre-lyophilization potency is re-assayed by TCID50 to verify interference below 0.5 log10 TCID50. The lyophilization cycle is extended by 2–4 h primary drying because increased total solids raise dried cake resistance. This formulation track is used only when target animal safety and efficacy data support compatibility under VICH GL44 and EU GMP Annex 2; published data for this specific configuration is limited, and release limits are assigned lot-by-lot. The terminal product is a polyvalent live freeze-dried injection in 2.0 mL fill volume, for intramuscular administration after reconstitution.
Intradermal delivery of live swine epidemic encephalitis vaccine through a spring-powered needle-free injector creates transient shear rates above 105 s−1; without shear protection, infectivity titre can fall by 0.5 log10 TCID50 per actuation. The intradermal solution formulation uses concentrated live virus bulk at 2.0–3.5% v/v, hydroxypropyl methylcellulose 0.15% w/v, trehalose 2.0% w/v, and sodium chloride 0.85% w/v; the target dose is 0.2 mL per intradermal site delivering 103.2 TCID50. Aseptic compounding is performed at 2–8 °C with 60 rpm low-shear mixing to avoid polymer degradation; the solution is passed through 0.22 μm PVDF membrane and filled into 5 mL Type I glass vials with 13 mm chlorobutyl stoppers. Device validation on the filling line uses a nozzle diameter 0.15 mm and pressure 4.3 MPa; titre retention after 20 actuations is above 90%. Compliance includes Ph. Eur. 5.1.1 for aseptic preparation, Ph. Eur. 2.6.1 for sterility, ISO 13485 design controls for the device, and IEC 60601-1 electrical safety if a powered injector is used. The terminal product is an aqueous intradermal solution in single-dose vials for needle-free administration to swine.
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Swine Epidemic Encephalitis Vaccine, Live Veterinary Grade API, released under model designation SEELive-Vx/102, is a lyophilized antigen concentrate intended solely for incorporation into finished veterinary immunobiologicals. The active fraction contains attenuated swine epidemic encephalitis virus propagated on a manufacturer-specified cell substrate, clarified by centrifugation, mixed with a stabilizer system, and desiccated to a controlled residual moisture. The resulting dry cake is not dispensed as a final sterile injectable in this presentation; it is formulated into tablets, injections, capsules, powders, granules, premix, and solutions only after formulation compatibility testing. Batch release includes infectivity, identity, moisture, sterility, mycoplasma, and extraneous-agent determinations, with values stated on the certificate of analysis. Storage is at −20 °C to +5 °C with protection from light and atmospheric moisture.
Lyophilization is used because the live virus is thermolabile in aqueous suspension. The cake is typically white to off-white, with a collapse temperature determined by differential scanning calorimetry; freeze-drying cycles are run at shelf temperatures from −40 °C during primary drying to +20 °C during secondary drying, with chamber pressure maintained between 50 µbar and 150 µbar. The release specification for residual moisture is ≤ 3.0% w/w by Ph. Eur. 2.5.12. The stabilizer matrix is formulated without reducing sugars because reducing sugars can glycate surface glycoproteins and reduce infectivity. The amorphous phase should possess a glass transition temperature above 40 °C to avoid cake shrinkage; collapsed cakes increase residual moisture and titre heterogeneity across the batch. Primary drying endpoint is determined by comparative pressure measurement; the cycle is advanced only when product temperature approaches shelf temperature without a rise in chamber pressure. Secondary drying removes bound water, and moisture is confirmed by Karl Fischer titration with oven extraction. Failures typically appear as collapsed cakes, meltback, or vial-to-vial titre heterogeneity linked to insufficient freezing rate or excessive fill depth. The liquid concentrate fill volume before drying is limited by a cake height-to-vial diameter ratio not exceeding 1.5:1 to maintain heat transfer and drying reproducibility. Reconstitution is performed in a dry nitrogen-purged isolator at 15–25 °C after vials have equilibrated to room temperature. The live particle is sensitive to pH below 6.0, to exposure above 37 °C, and to high-shear mixing; downstream unit operations must remain below the validated titre-loss threshold. Published data for this specific swine encephalitis strain under tableting conditions are limited, so each formulation change requires infectivity-recovery studies rather than reliance on general platform assumptions.
For oral powders, granules, and premixes, the API is geometrically diluted with a carrier selected for low reducing-sugar content and low surface moisture, typically lactose monohydrate or a sucrose-maltodextrin blend. A 1:10 geometric preblend is prepared in a V-shell blender or bin blender filled to 50–65% of total volume; mixing speed is maintained below 25 rpm to avoid shear-induced degradation of the viral envelope. Carriers with loss-on-drying above 1.0% are pre-dried in a fluid-bed dryer at 40 °C for not more than 30 min and cooled before blending. The active fraction must not be pre-dried under these conditions. Segregation is controlled by matching carrier and API particle size distributions; if the D90 ratio exceeds 3:1, static adhesion to stainless steel contact surfaces may produce low assay values in initial and final samples. Blend homogeneity is assessed by sampling from 10 positions and testing titre per unit mass; acceptance requires relative standard deviation ≤ 5.0% for potency. If the RSD exceeds this, re-blending is limited to 10 min because additional shear can lower infectivity. For granulation, low-shear fluid-bed granulation with inlet air temperature not exceeding 30 °C is preferred. High-shear granulators with tip speeds above 1 m/s are not used because local heating and shear can reduce infectivity by more than 0.5 log10 TCID50/g. Tablet compression, when required, is limited to a maximum compression pressure of 150 MPa and granulate moisture below 2.0%. Magnesium stearate lubrication is kept at 0.5–1.0% w/w and mixing time below 5 min because prolonged hydrophobic lubrication can interfere with disintegration and oral mucosal antigen release. Capsule filling on tamping-pin machines is performed at low pin compression; dosator-type machines are configured to avoid powder compaction above 50 MPa. The final capsule is not further coated with solvent-based film unless titre recovery after a 24 h coating process is above 90% of the pre-coating titre. Acidic effervescent excipients and citric acid-based matrices are incompatible unless the final product is shown to maintain pH above 6.0 during dissolution.
Where the API is converted into an injectable solution, the lyophilized cake is reconstituted in sterile phosphate-buffered saline at pH 7.2–7.4 or a manufacturer-specified diluent containing partially hydrolyzed gelatin and sucrose. The reconstituted solution is held at 2–8 °C and used within 2 h; aqueous stability beyond this window is lot-dependent and must be verified by infectivity assay. The injectable preparation must meet 9 CFR 113.6 general requirements for live virus vaccines and is tested for sterility by 9 CFR 113.26, mycoplasma by 9 CFR 113.28, and endotoxin by Ph. Eur. 2.6.14. Sterilizing-grade filtration through a 0.22 µm membrane after reconstitution is not permissible for the antigen fraction because viral particles may be retained or adsorbed; aseptic processing is used for the API, and the diluent is sterilized separately. Intramuscular or subcutaneous routes are used; intravenous administration is not indicated. Gentle swirling rather than vortexing is required during reconstitution, because vigorous agitation can denature surface glycoproteins. If a preservative is added, the preservative must be screened for virucidal activity; thimerosal and benzalkonium chloride may be incompatible with enveloped RNA viruses at typical preservative concentrations. Visible and subvisible particulate matter are controlled at the API stage by clarification before lyophilization, not by filtration after reconstitution. If the solution is mixed with other live antigens, compatibility must be demonstrated by co-titration and identity-specific PCR because unintended interference can suppress the immune response.
The live attenuated API differs from inactivated whole-virus and subunit vaccines in replication competence, adjuvant requirement, and immune response profile. The live virus replicates in the host after administration, stimulating both humoral and cell-mediated immunity; inactivated whole-virus preparations generally require adjuvants and produce primarily antibody-mediated responses. Subunit and peptide antigens are more thermostable and easier to formulate into tablets and capsules, but they lack the full spectrum of conformational epitopes. These differences have direct formulation consequences: the live API cannot be exposed to the drying temperatures or solvent systems tolerated by subunit proteins, and the batch-release infectivity assay is a critical quality attribute that does not exist for killed or subunit products. The absence of adjuvant may alter local reactogenicity profile; however, the live agent can be shed and may require segregation of vaccinated animals from non-vaccinated susceptible animals for a defined period. Manufacturer documentation should give the minimal isolation interval; if not stated, the absence of a peer-reviewed shedding profile for this specific vaccine limits use in mixed-status herds. This is a meaningful difference from inactivated or subunit products, which do not shed replication-competent antigen.
| Attribute | Live Attenuated API | Inactivated Whole-Virus | Subunit/Peptide |
|---|---|---|---|
| Replication competence | Present in target host | Absent | Absent |
| Adjuvant requirement | Often absent | Commonly required | Required |
| Cell-mediated immunity | Yes | Limited | Limited or absent |
| Thermotolerance | Low in dried cake; very low in solution | Moderate | High |
| Oral dosage form feasibility | Requires low-shear processing and pH ≥ 6.0 | Feasible with acid-resistant coating | Feasible |
| Residual infectivity assay | Required, TCID50 | Not applicable | Not applicable |
| Reversion risk | Monitored by animal passage | None | None |
The API is intended for downstream formulation and is not a ready-to-use final product. It therefore differs from marketed ready-to-use vaccines in that no diluent, preservative, or adjuvant is included. The absence of these components gives the formulator flexibility in selecting the final dosage form but transfers compatibility risk to the downstream process. Each formulation matrix must be qualified against the release titre, and the stability-indicating method must be revalidated for the final dosage form because matrix components can interfere with the TCID50 readout.
Compliance verification follows a matrix of tests. Table 2 lists the critical test procedures and the corresponding standard designations used for batch release.
| Quality Attribute | Test Method | Release Criterion |
|---|---|---|
| Appearance | Visual inspection | White to off-white cake, no collapse |
| Identity | RT-qPCR | Positive for swine epidemic encephalitis virus |
| Virus titre | Spearman-Kärber TCID50 assay | Not less than 5.0 × 105 TCID50 per dose equivalent after reconstitution |
| Residual moisture | Ph. Eur. 2.5.12, USP <921> | ≤ 3.0% |
| Sterility | 9 CFR 113.26, Ph. Eur. 2.6.1 | No growth |
| Mycoplasma | 9 CFR 113.28, Ph. Eur. 2.6.7 | Negative |
| Endotoxin | Ph. Eur. 2.6.14 | ≤ 5 EU per dose |
| Extraneous agents | 9 CFR 113.6 | Negative |
| Storage stability | VICH GL17 | Maintain titre at −20 °C to +5 °C for 24 months |
For downstream processing, the API should be used only in equipment with validated cleaning and containment. The residual moisture specification must be maintained during any opening of the container; the processing environment should be controlled at ≤ 40% RH and 15–25 °C. Contact with chlorine-based disinfectants, heavy-metal ions, strong oxidizing agents, and acidic buffers below pH 6.0 is incompatible with the live antigen. Mixing with amine-based additives should be avoided unless compatibility is experimentally confirmed, because residual aldehydes or amines may react with surface glycoproteins. If the API is incorporated into capsules, hard shell dissolution testing should confirm that the capsule releases within 30 min in simulated gastric fluid adjusted to pH 6.0; standard gastric fluid at pH 1.2 is not suitable for live antigen survival. These boundaries define the operational envelope for formulation development with this veterinary grade API.
