| HS Code | 401979 |
| Product Name | Pseudorabies Vaccine, Live Veterinary Grade API |
| Vaccine Category | Live Attenuated Viral Vaccine |
| Active Immunogen | Live attenuated Suid herpesvirus 1 (Pseudorabies virus) |
| Api Grade | Veterinary Grade |
| Target Species | Swine |
| Indications | Prevention and control of pseudorabies (Aujeszky's disease) in pigs |
| Dosage Forms Available | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Route Of Administration | Intramuscular, subcutaneous, oral, or intranasal depending on dosage form |
| Adjuvants And Stabilizers | Contains veterinary-grade stabilizers, cryoprotectants, and/or adjuvants as required |
| Shelf Life | Typically 12 to 24 months from manufacturing date, according to final formulation |
| Withdrawal Period | Zero days for swine when administered as directed |
| Packaging | Sealed sterile vials or moisture-proof sachets with desiccant |
As an accredited Pseudorabies 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 | Packaged in sterile, vacuum-sealed, light-resistant containers. Pseudorabies Vaccine, Live Veterinary Grade API available in 100g, 500g, or 1kg quantities. |
| Container Loading (20′ FCL) | 20′ FCL: temperature-controlled container loading of live veterinary-grade Pseudorabies Vaccine API, securely palletized, with cold-chain monitoring for safe transit. |
| Shipping | Ship Pseudorabies Vaccine (live, veterinary grade) under strict cold chain at 2–8°C, protected from light. Use validated insulated containers with gel packs and temperature loggers. Ensure compliant export documentation, customs clearance, and safe handling to prevent leakage. Deliver worldwide via expedited air freight to maintain potency. |
| Storage | Store at 2–8°C in a tightly sealed, light-protected container. Do not freeze or expose to excessive heat, as live virus potency may diminish. Avoid moisture; use aseptic handling. Keep out of direct sunlight. This veterinary-grade API remains stable under controlled cold-chain conditions until formulation into tablets, injections, capsules, powders, granules, premixes, or solutions. |
| Shelf Life | Shelf life typically 12–24 months when stored at 2–8°C, protected from light; avoid freezing. |
For intramuscular immunisation programmes in breeding herds, the live pseudorabies vaccine API is converted into a lyophilised injectable finished product rather than a dry-mixed oral powder; direct compression into tablets or encapsulation is not tolerated because the suid herpesvirus 1 envelope loses infectivity under compression heating, desiccation, and gastric pH below 4.0. Batch records from 2.0 mL and 5.0 mL fill campaigns show that the viral API addition ratio is set by final container titre, not by mass percentage: the release target is 105.5 TCID50 per 2.0 mL reconstituted dose, and the formulated bulk is produced by mixing clarified virus harvest with sucrose-phosphate-glutamate-albumin stabiliser at a 1:1 v/v ratio before 0.2 µm filtration. The stabiliser contributes 2.0–5.0% w/v sucrose-equivalent lyoprotectant and 0.5–1.5% w/v gelatin or alternative protein hydrolysate; the exact ratio is adjusted after pre-filtration infectivity titration so that final vial fill carries a +0.3 log10 process-loss allowance. Downstream production proceeds through PK-15 or ST cell culture in roller bottles or multi-layer flasks with multilayer surface areas up to 6,320 cm2 per unit, infection at an MOI of 0.01–0.1 TCID50/cell, harvest at 80–90% cytopathic effect, depth filtration through 0.45 µm followed by 0.2 µm, stabiliser addition, and aseptic filling into Type I borosilicate glass vials under ISO Class 5 laminar airflow within an ISO Class 7 cleanroom as defined by ISO 14644-1:2015. Lyophilisation is executed with a shelf ramp to -45 °C, primary drying at -25 °C shelf temperature under 100 µbar, and secondary drying at +20 °C until residual moisture is ≤2.5% by Ph. Eur. 2.5.32. The terminal finished product is a lyophilised plug in 10 mL Type I glass vials with bromobutyl stoppers and aluminium flip-off seals, stored at 2–8 °C; after reconstitution it produces the injectable dose for gilts, sows, and boars. Compliance is governed by USDA 9 CFR 113.212 for attenuated pseudorabies vaccine, Ph. Eur. monograph 0744 for live Aujeszky’s disease vaccine, and OIE Terrestrial Manual Chapter 2.1.2 for production and batch release verification. Operational boundaries include viral degradation in liquid hold: clarified bulk held at 2–8 °C beyond 8 h before lyoprotectant addition can lose more than 0.5 log10 TCID50/mL, and resuspension of freeze-dried cake in diluents containing quaternary ammonium compounds should be avoided because residual cationic surface activity can reduce infectivity.
Batch-to-batch variance observed on production lines is concentrated in the upstream cell culture segment: a deviation in roller-bottle rotation speed above 0.6 rpm or a fall in cell viability below 90% at infection reduces final titre by 0.3–0.7 log10 TCID50/mL and forces rebalancing of the stabiliser-to-harvest ratio. Filling lines equipped with peristaltic pumps using 1.6 mm ID platinum-cured silicone tubing and 0.2 µm inline PES filters generate lower shear than rotary piston pumps, reducing titre loss during transferred bulk; transient shear above 2,000 s-1 in the presence of 5% w/v sucrose can produce a 0.2–0.4 log10 titre drop in the unfrozen liquid stream.
Residual moisture and glass transition parameters form the principal stability boundary for lyophilised live pseudorabies vaccine; the formulation is not a simple excipient blend but a virus-loaded amorphous solid whose collapse behaviour depends on lyoprotectant crystallisation. The addition ratio of API is fixed as a virus-to-stabiliser v/v proportion rather than a powder weight fraction: a representative high-stability matrix contains 2.5% w/v sucrose, 0.5% w/v gelatin, 0.1% w/v potassium glutamate, and viral harvest adjusted to deliver 105.5 TCID50 per dose after reconstitution. Sucrose is held between 2.0% and 5.0% w/v because at concentrations below 2.0% the collapse temperature drops below usable primary drying conditions, while above 5.0% the cake becomes hygroscopic and residual moisture rises unless secondary drying is extended. Published data for this exact API-stabiliser configuration is limited; therefore each incoming stabiliser lot is screened by differential scanning calorimetry and freeze-dry microscopy to determine the critical formulation temperature before scale-up.
Downstream process control depends on equipment-specific thermal mapping: pre-drying of stoppers is required when loading area relative humidity exceeds 60% RH, and stoppers with moisture content above 0.5% w/w transfer water to the lyophilised cake during vacuum break. The freeze dryer shelf uniformity must be within ±0.5 °C across the batch; a deviation of +1.0 °C above the collapse temperature in the primary drying plateau causes localised cake shrinkage and non-uniform titre distribution in the vial set. The terminal finished product is a rigid, open-porous lyophilised plug with residual moisture ≤2.5% by Ph. Eur. 2.5.32; this level is confirmed by Karl Fischer titration after destructive sampling of 10 vials per batch. The relevant finished product compliance standards are Ph. Eur. 0744 and 9 CFR 113.212, with excipient control against the applicable Ph. Eur. monographs for sucrose and gelatin.
| Quality attribute | Standard designation | Control limit |
|---|---|---|
| Finished product sterility | Ph. Eur. 2.6.1 | No growth after 14 days |
| Mycoplasma absence | Ph. Eur. 2.6.7 | No mycoplasma |
| Virus titre after reconstitution | 9 CFR 113.212 | 105.5 TCID50/dose |
| Residual moisture | Ph. Eur. 2.5.32 | ≤2.5% |
Reconstitution diluent co-packaging is validated as a separate downstream fill-finish operation because the live PRV API experiences a second aqueous environment only minutes before injection; the diluent therefore must not contain preservatives, benzyl alcohol, or cationic polymers that reduce infectivity at room temperature. The formulation addition ratio for final use is 2.0 mL sterile diluent per single dose of lyophilised vaccine, bringing the injected volume to 2.0 mL with a target titre of 105.5 TCID50; for 10-dose and 50-dose vials the diluent volume is scaled proportionally. The downstream process for the diluent side is separate from viral filling: water for injection is autoclaved at 121 °C for 15 min, filled into low-density polyethylene ampoules or polypropylene bottles through a 0.2 µm sterilising filter under ISO Class 5 conditions, and terminal sterilised where container format permits. The terminal finished product type is a sterile diluent co-pack without preservatives; after reconstitution, the diluted vaccine should be stored at 2–8 °C and used within 4 h, because infectivity loss in the reconstituted state can exceed 0.3 log10 after 6 h at 20 °C. Compliance is aligned with Ph. Eur. 2.6.1 for sterility and Ph. Eur. 5.1.1 for sterilisation methods; in the United States, the diluent falls under the licensed product file as part of 9 CFR 113.212 compatibility testing. Operational boundary: if the diluent pH falls below 6.0 or above 7.8 at release, reconstitution can reduce recovered titre by more than 0.5 log10; therefore pH is adjusted with phosphate buffer to not less than 6.5 and not more than 7.5.
In fill-finish facilities, reconstitution compatibility is tested with lot-to-lot diluent variations; a batch-to-batch difference in polyethylene extractables above 0.5 ppm total organic carbon has been associated with delayed cake wetting and residual dry aggregates in the vial, which reduces injectable uniformity. The diluent lot release therefore includes total organic carbon limit ≤0.5 ppm and endotoxin limit ≤0.25 EU/mL according to Ph. Eur. 2.6.14.
When regional licensing requires fill-finish to occur at a separate establishment, the live pseudorabies API is transferred as a frozen formulated bulk rather than as a finished vial. This scenario is a legitimate downstream supply route for veterinary vaccine manufacturing networks with centralised antigen production and local lyophilisation. The addition ratio in frozen bulk is set by volume after optional tangential flow filtration: if concentration is required, virus harvest is concentrated 10- to 50-fold through 0.45 µm or 100–300 kDa polyethersulfone cassettes, then mixed at a 1:1 v/v ratio with a cryoprotectant-stabiliser matrix containing sucrose 2.0–5.0% w/v and glycerol 5.0–10.0% v/v. Published data for this exact virus-stabiliser configuration is limited; freezing-rate validation is therefore performed in the receiving establishment with product-filled single-use bags not exceeding 2.0 L to ensure uniform heat transfer. The downstream process uses controlled-rate freezing at -1.0 °C/min to -70 °C, then storage at ≤ -70 °C in stainless steel canisters; the fluid path is single-use fluoropolymer bags with 0.2 µm integrity-tested inlet filters to prevent bioburden ingress. Terminal finished product type is a frozen formulated bulk intermediate, not an injectable final product; after thaw in a water bath at 37 ± 1 °C for 10–15 min, the thawed bulk is diluted into final formulation buffer, filled, and lyophilised under the receiving site’s licence. Handover compliance is maintained through USDA 9 CFR Part 103 for import/export permits and Ph. Eur. 2.6.1 and 2.6.7 for sterility and mycoplasma testing. Operational boundary: thawed bulk must be refrozen only once and held at 2–8 °C for not more than 4 h before lyoprotectant dilution; failure to adjust pH after thaw can produce titre loss greater than 0.5 log10.
Equipment validation spots: icy shell growth in large bags can occur if the controlled-rate freezer has a centre-to-edge temperature gradient above 3 °C; the resulting cryoconcentration may produce local pH shift and infectivity loss. Bag thickness is therefore limited to 2 cm before freezing, and cassette spacing is fixed by the freezer manufacturer’s validated load pattern.
High-throughput finishing sites that vaccinate continuous flow barns order the live PRV API in 50-dose or 100-dose lyophilised presentations rather than single-dose vials; the final product is intended for herd vaccination of growing pigs from 8–12 weeks of age, with booster timing established by maternal antibody decline. The addition ratio inside the fill is scaled from the same release target: 105.5 TCID50 per 2.0 mL dose, meaning a 100-dose vial must contain 107.5 TCID50 after reconstitution in 200 mL of diluent. Downstream process adjustments for large vials include longer fill nozzle dwell, stopper placement under partial vacuum to prevent cake collapse, and lyophilisation cycle extension because the increased fill depth changes primary drying resistance; cake thickness is kept below 1.5 cm to permit adequate sublimation. Compliance remains USDA 9 CFR 113.212 and Ph. Eur. 0744, with in-use stability tested under the approved product file. Terminal finished product type is a multi-dose lyophilised plug in 100 mL Type I glass vials with a bromobutyl stopper rated for repeated needle entry, reconstituted with 200 mL diluent and administered as 2.0 mL intramuscular per pig. Operational boundary: after first puncture, the vial must be held at 2–8 °C and used within 4 h; repeated needle entry through a stopper can introduce bioburden if the stopper is not sanitised with sterile alcohol before each puncture. Published multi-dose field stability data for this specific 100-dose configuration is limited; the in-use period is therefore justified by conservative microbial challenge testing rather than long-term viral titre data.
Batch records from commercial filling of 100-dose vials show that cake uniformity is the dominant processing risk: infrared thermography after primary drying reveals radial moisture gradients up to 0.8% between centre and edge if shelf temperature map drifts beyond ±1 °C, and this gradient can produce greater than 0.3 log10 titre variation between first and last dose drawn from the reconstituted vial. Production lines using 100-dose formats therefore use controlled partial stopper closure during shelf unloading at ≤40% RH to prevent water uptake in the cake before aluminium sealing.
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Pseudorabies Vaccine, Live Veterinary Grade API is a bulk live-attenuated Suid herpesvirus 1 (SuHV-1) antigen concentrate intended exclusively for downstream formulation into injectable, oral, and premix finished veterinary medicinal products. The API is standardized by virus titer rather than total antigen mass because the product remains replication-competent. It is supplied as a frozen cell-culture harvest or a lyophilized powder/cake and must not be administered directly without formulation-specific reconstitution, granulation, compression, encapsulation, or solution compounding. The product designation is tied to the master seed lineage and deletion marker rather than a conventional physical model number. Finished dosage forms derived from this API include tablets, injections, capsules, powders, granules, premixes, and solutions, provided that each downstream operation preserves viral infectivity and meets the relevant marketing authorization.
The active virus in the API is a glycoprotein E (gE)-deleted Bartha K61 lineage propagated on porcine kidney-derived continuous cells, most commonly PK-15 or equivalent qualified cell substrate. The gE deletion removes full-length glycoprotein E while retaining glycoprotein B and glycoprotein D, which are sufficient to induce neutralizing antibody and cell-mediated immunity. The SuHV-1 genome is a linear double-stranded DNA of approximately 143 kb; identity testing therefore uses quantitative PCR targeting gB and gE deletion boundaries. The API is not a purified subunit and contains residual cell-culture components, which are controlled through harmonized downstream clarification and purity specifications.
Upstream production is performed in stirred-tank or single-use bioreactors with microcarrier or suspension-adapted cell lines. Growth phase temperature is controlled at 37 °C, pH at 7.2 ± 0.2, and dissolved oxygen at 40–60% air saturation. Infection at a multiplicity of infection between 0.01 and 0.1 is followed by a production phase at 34–36 °C for 48–96 h until cytopathic effect reaches the validated harvest threshold. Harvest is clarified by continuous centrifugation at approximately 10,000×g or by depth filtration through 0.45–0.65 µm capsules. Terminal sterile filtration through 0.2 µm membranes is not possible for this product because the enveloped virion particle size is approximately 150–200 nm; therefore, aseptic process control is used from harvest through final freeze-drying or freezing.
Stabilization typically uses sucrose, trehalose, sorbitol, or hydrolyzed gelatin alternatives at 5–10% total solids in a phosphate or Tris buffer system. The API is maintained at pH 7.0–7.6 to avoid envelope fusion and loss of infectivity. Liquid frozen presentations are stored at −70 °C or below; lyophilized presentations are produced by controlled freeze-drying with reconstitution to a nominal volume. The API is not a film-coated tablet or filled capsule at release; it is a bulk biological active ingredient subject to the same containment and traceability requirements as a master seed-derived virus bank.
The release profile is based on the current OIE Terrestrial Manual Chapter 3.1.2 and relevant Ph. Eur. methods where applicable. Values are typical batch-release limits for lyophilized bulk API unless otherwise indicated:
| Parameter | Method/standard | Typical limit |
|---|---|---|
| Identity | gB-specific quantitative PCR and gE-deletion PCR per OIE Chapter 3.1.2 | gB positive; full-length gE not detected |
| Virus titer | TCID50 assay on PK-15 or Vero cells | ≥ 10^6.5 TCID50/mL after reconstitution |
| Sterility | Ph. Eur. 2.6.1, 9 CFR 113.26 | No growth after 14 days |
| Mycoplasma | Ph. Eur. 2.6.7, 9 CFR 113.28 | Negative |
| Residual moisture | Ph. Eur. 2.5.12 Karl Fischer titration | ≤ 3.0% for lyophilized cake |
| pH after reconstitution | Ph. Eur. 2.2.3 | 7.0–7.6 |
| Endotoxin | Ph. Eur. 2.6.14, USP <85> where injectable | ≤ 10 EU/mL where specified |
Frozen liquid bulk that has not been lyophilized carries a lower minimum titer to account for freeze-thaw loss; however, the same identity and purity criteria apply. Batch release requires a negative extraneous-agent result from porcine parvovirus and bovine viral diarrhea virus exclusion where cell substrate or serum history indicates risk. The API is not released solely on TCID50; the ratio of infectious titer to total genomic copies by quantitative PCR is monitored to detect poor-synchrony downstream formulations. This ratio is not a public monograph requirement, but it is a useful internal control at production scale.
Production-scale behavior shows that harvest titer can vary by 0.3–0.8 log10 TCID50/mL between batches when serum-free adaptation is incomplete or when cell passage number shifts. The clarified bulk is therefore concentrated or diluted after harvest before stabilization to reduce potency drift in finished dosage forms. Downstream formulation must account for titer loss at each unit operation: freeze-drying may cause 0.2–0.5 log10 loss, while granulation and compression can cause additional loss if product temperature exceeds 30 °C.
Potency retest at the time of finished product formulation uses the same TCID50 method. For lyophilized bulk, the acceptable titer loss after one reconstitution cycle is typically not more than 0.5 log10; if loss exceeds this value, investigation of cake collapse, moisture ingress, or stabilizer failure is required. For frozen liquid bulk, shipment is performed on dry ice with continuous temperature monitoring. A temperature excursion above −60 °C for more than 48 h requires rejection or in-house retesting under an approved deviation protocol.
Oral solid dosage forms containing live SuHV-1 require protective formulation because the viral envelope is acid-labile below pH 3.0 and sensitive to shear-induced heat. Direct compression of plain API blends is generally not suitable; the API is first adsorbed onto microcrystalline cellulose, maltodextrin, or low-moisture lactose in a jacketed high-shear granulator at product temperature not exceeding 30 °C. Binder systems are low-viscosity hydroxypropyl methylcellulose or polyvinylpyrrolidone at 2–5% solids. Granules are dried to residual moisture ≤ 3.0% before compression or encapsulation.
Tablet cores may require enteric coating with methacrylic acid copolymer dispersion at a weight gain of 8–12% to prevent gastric inactivation; capsule presentations can use hydroxypropyl methylcellulose capsules with acid-neutralizing excipients that maintain local pH above 4.0 for 45–60 min. Fluid-bed top-spray granulation is preferred over high-shear rotor systems because inlet air dew point below −20 °C and product temperature below 30 °C can be maintained. If high-shear granulation is unavoidable, the wet massing time should be limited and post-step infectivity retested. Published data for this specific presentation is limited, so each oral solid design must be qualified by TCID50 loss at compression and after 6 months at 2–8 °C.
Spray coating of enteric films in a pan coater must control bed temperature below 30 °C to avoid thermal inactivation; organic solvent-based coating is generally unsuitable unless the solvent is removed below the virus degradation threshold and residual solvent is controlled. Aqueous polymer dispersions are preferred. For powders and granules, lyoprotectants present in the API, such as sucrose or trehalose, can become sticky at high humidity; therefore, dry blending and packaging under ≤ 30% RH is necessary to prevent particle agglomeration and moisture-mediated titer loss.
Granules and premixes for feed or drinking-water administration require additional protection from ambient moisture and feed-processing heat. If RH exceeds 60%, pre-drying and blending under dehumidified air at ≤ 30% RH are required. Carriers should be non-ionic and free of carbonate salts that raise local pH above 8.0. Pelleting temperatures above 65 °C can inactivate live SuHV-1 within minutes, so post-pelleting application or microencapsulation is used when heat exposure cannot be avoided.
Premix formats for medicated feed require an approved carrier and must be homogeneously distributed at the target inclusion rate. Blend uniformity is assessed by quantitative PCR rather than viral culture alone because culture variability at low inclusion rates can confound potency. The API should not be mixed with organic acids used as feed preservatives if the resulting pH falls below 4.0; such combinations can reduce infectivity in the premix before consumption.
For injectable finished products, the lyophilized API is reconstituted in sterile diluent according to the finished product label. The API must not be combined with oil-in-water emulsions, aluminum hydroxide adjuvants, or cationic antimicrobial preservatives unless compatibility has been demonstrated, because these components can alter pH or disrupt the viral envelope. Reconstituted solutions are used within 2 h at 2–8 °C unless real-time stability data support longer holding. Parenteral manufacturing equipment must be free of quaternary ammonium residues and hypochlorite because SuHV-1 is highly sensitive to membrane-disrupting disinfectants. Phosphate-buffered saline at osmolality 280–320 mOsm/kg is generally compatible, but hypertonic sodium chloride above 0.9% may accelerate aggregation.
Solution presentations for oral or parenteral use are compounded from frozen or lyophilized bulk under aseptic conditions. The virus is not stable in unbuffered water; diluents with pH 7.0–7.6 and stabilizers such as sucrose 5% are preferred. Chlorinated drinking water should be treated with sodium thiosulfate or alternative acceptable dechlorination before oral solution administration; copper and iron ions can also reduce infectivity and should be chelated where necessary. Exact compatibility limits must be established by finished product validation because published data for this specific SuHV-1 formulation configuration is limited.
The gE deletion in the API enables differentiation of infected from vaccinated animals using validated gE-specific ELISA. Pigs vaccinated with a gE-negative live vaccine remain seronegative for gE but seroconvert to gB and other protective antigens. Regulatory DIVA surveillance in pseudorabies-free regions therefore relies on gE antibody status; vaccinated uninfected populations test gE-negative, whereas field infection with wild-type SuHV-1 induces gE antibodies. This is not possible with non-marker live vaccines, killed whole-virus vaccines, or older SuHV-1 antigen APIs that do not carry the deletion. A killed whole-virus vaccine containing gE cannot be used for DIVA unless the companion diagnostic panel is specifically validated; most eradication programs require marker-negative live or subunit APIs.
Compared with inactivated whole-virus SuHV-1 antigen APIs, the live API requires a lower antigen input per dose because replication after administration amplifies the immunogenic signal. Inactivated products generally require adjuvants and a two-dose primary course; live attenuated SuHV-1 can induce cell-mediated immunity and mucosal immunity under marketing authorization conditions. Subunit gB or gD APIs may provide DIVA markers, but they often do not generate the same breadth of cytotoxic T-lymphocyte responses. The clinical choice between live and killed APIs is therefore determined by vaccination program objectives: eradication programs favor marker live or marker subunit products, while high-biosecurity units with diagnostic constraints may prefer inactivated or subunit products. The live API is not appropriate for use in animals that are immunosuppressed or undergoing corticosteroid therapy unless the finished product authorization explicitly permits such use.
Safety in pregnant sows is strain-dependent. The Bartha K61 lineage is historically regarded as attenuated and has been used in breeding herds under authorized conditions, but the API itself is not a finished product and cannot be administered directly. Each finished product must demonstrate freedom from reversion to virulence by passage studies and must meet local regulatory requirements for shedding and tissue distribution. The live virus may be shed in nasal secretions after vaccination; therefore, in-contact susceptible animals should be managed according to label restrictions, particularly in mixed-age populations.
Unlike live bacterial vector vaccines or mRNA veterinary products, this API contains the whole SuHV-1 particle with full-length gB and gD but partial deletion of gE. The presence of complete viral envelope proteins allows presentation of conformational epitopes in their native lipid bilayer context. This property is not matched by recombinant protein subunit APIs, which may require stronger adjuvants and repeated administration. Conversely, the live API requires cold-chain integrity and is more sensitive to formulation stress than killed vaccines or subunit proteins, so downstream manufacturing controls must be tighter.
Operational boundaries include strict avoidance of repeated freeze-thaw cycles, pH excursions below 3.0 or above 8.0, residual disinfectants, and extended high-shear mixing above 30 °C. Incompatible excipients include cationic polymers and surfactants that disrupt the envelope, strong oxidizers, and alkaline buffers. Waste streams containing the live API are inactivated with sodium hypochlorite 0.5% for at least 30 min or by autoclaving at 121 °C for 30 min. Facilities handling replication-competent SuHV-1 API must operate under biological containment appropriate to the local regulation and must restrict access to authorized personnel only.
