| HS Code | 870265 |
| Product Name | Marek's Disease Vaccine, Live (Strain FC-126) Veterinary Grade API |
| Active Ingredient | Live attenuated turkey herpesvirus (HVT), strain FC-126 |
| Vaccine Type | Live viral vaccine |
| Target Species | Chickens and poultry |
| Indication | Active immunization against Marek's disease |
| Mechanism Of Action | Viral replication in the host induces a protective immune response against Marek's disease virus |
| Api Grade | Veterinary-grade active pharmaceutical ingredient (API) for vaccine manufacturing |
| Formulation Compatibility | Compatible with tablets, injections, capsules, powders, granules, premix, and solutions |
| Route Of Administration | Injectable or as directed in final veterinary dosage form |
| Potency Expression | Potency is quantified as plaque-forming units (PFU) per dose |
| Shelf Life | Typical shelf life is 12-24 months when stored under specified conditions |
As an accredited Marek's Disease Vaccine,Live(Strain FC-126) 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 glass vials, 10 mL, with rubber stoppers and crimped aluminum seals. Quantity: 1000 doses per vial. |
| Container Loading (20′ FCL) | Refrigerated 20′ FCL loading; live vaccine maintained cold, cushioned and secured with gel packs, labeled with handling and temperature documentation. |
| Shipping | This live viral vaccine must ship under strict temperature control, typically on dry ice or at +2–8°C depending on formulation, using validated insulated containers. Use temperature data loggers, protect from light, and follow IATA/ADR regulations for biological substances and dry ice to ensure efficacy. |
| Storage | Store under refrigeration at 2–8°C in the original, tightly closed container. Protect from light and moisture. Do not freeze or expose to heat, as viability of the live FC-126 strain may be compromised. Use aseptic handling during preparation for tablets, injections, capsules, powders, granules, premixes, or solutions. Ensure strict cold-chain maintenance throughout storage and distribution. |
| Shelf Life | Shelf life is typically 18 months when stored in liquid nitrogen at -196°C; reconstituted vaccine must be used within 2 hours. |
Within day-old hatchery vaccination lines, FC-126 live viral API is diluted and administered subcutaneously in 0.2-mL doses. The release specification for this route is aligned with USDA 9 CFR 113.330 and Ph. Eur. 0589 where the product is registered under a European marketing authorisation. Hatchery injection cabinets equipped with 21-gauge needles and 1,000-dose vial racks typically operate at 8,000–12,000 chicks/h; field batch records show dose-volume drift exceeds ±5% when peristaltic tubing sets are not replaced after 6–8 h of continuous run. Because the API is a live herpesvirus of turkeys, it is not converted into tablets or capsules; tabletting shear and gastric acid exposure destroy infectivity. The formulation addition ratio is not a fixed mass percentage but is derived from bulk infectivity. For a clarified bulk titre of 6.2 log10 PFU/mL, a 1:200 v/v dilution into a stabilised diluent containing sucrose, phosphate buffer, and peptone yields approximately 1,580 PFU per 0.2-mL dose. The diluted suspension is held at 2–8°C in ice-jacketed bags and must be used within 2 h after hydration; holding beyond 2 h is associated with a 0.3 log10 titre loss in field transport data. Terminal finished products are 1,000-dose cell-associated suspension vials, 200-mL diluent bags, and hatchery kits matched by lot number.
Cell-associated FC-126 is produced in chicken embryo fibroblast monolayers, harvested by trypsinisation, and suspended in a cryoprotectant containing dimethyl sulfoxide at 7.5–10.0% v/v and fetal bovine serum at 10–20% v/v. The addition ratio of infected cells to cryoprotectant is set by viable-cell count and is commonly adjusted to 1×10^6–5×10^6 cells/mL before controlled-rate freezing at −1°C/min to −80°C, followed by liquid nitrogen vapour phase storage at −196°C. Compliance is verified under USDA 9 CFR 113.330 and Ph. Eur. 0589; post-thaw plaque assay on chicken embryo fibroblasts must demonstrate not less than 1,500 PFU per 0.2-mL dose. Downstream filling uses screw-cap cryovials or flame-sealed glass ampoules in 1,000-dose formats. Thawing is performed in water baths at 25–37°C for less than 90 s; hatchery failure data show that ampoules left at 25°C for more than 4 min before dilution lose 0.5 log10 PFU/mL, and refreezing of thawed product is prohibited. Terminal finished products are frozen cell-associated Marek's disease vaccines for dilution with cold Marek diluent immediately before injection.
For a cell-free FC-126 harvest destined for freeze-drying, the stabiliser system and cycle design determine residual infectivity rather than a single mass-based addition ratio. A stabiliser composed of 4.0% w/v sucrose, 1.0% w/v hydrolysed gelatin, and 0.4% w/v disodium hydrogen phosphate is used before lyophilisation; published data for FC-126-specific stabiliser limits is limited. Freeze-drying cycles maintain shelf temperature at −35°C during primary drying and chamber pressure at 50–100 µbar, with secondary drying at 25°C for 6–8 h. Residual moisture is controlled to ≤2.0% w/w by Karl Fischer titration as referenced in USP <921>. Formulation addition ratio before lyophilisation is derived from pre-freeze titre: a bulk titre of 6.0 log10 PFU/mL diluted 1:125 v/v into stabiliser gives a fill concentration of approximately 1,600 PFU per 0.2-mL liquid dose before freeze-drying. Downstream production uses Type I glass vials, halogenobutyl rubber stoppers, and aluminium flip-off seals. Terminal product types are 1,000-dose lyophilised plugs for reconstitution with 200 mL sterile diluent. Residual moisture above 2.5% w/w and prolonged oxygen exposure are incompatible with stable infectivity.
At 18–19 days of embryonation, automated in-ovo machines deliver 0.05 mL per embryo into the amniotic fluid. Production-scale systems process 20,000–70,000 eggs/h per line, with dose-volume coefficient of variation maintained below 5% only when the diluted vaccine viscosity remains between 1.0 and 3.0 cP at 25°C. The formulation addition ratio for this route is based on final infectivity concentration: a 1.0-mL bulk ampoule containing 1.5×10^6 PFU is diluted into 49 mL Marek diluent to yield 3.0×10^4 PFU/mL, equivalent to 1,500 PFU per 0.05-mL embryo dose. Diluent compatibility requires phosphate-buffered, sucrose-stabilised media with osmolality between 280 and 320 mOsm/kg; saline-only vehicle causes unacceptable sedimentation in machine reservoirs. Downstream filling assembles 50-mL injector bags, 18-gauge egg-punch needles, and sanitation ports that must be flushed free of peroxygen residues below 10 ppm. Compliance is maintained under USDA 9 CFR 113.330 and WOAH Terrestrial Manual Chapter 2.3.13. Terminal products are in-ovo vaccination kits for hatchery injection machines.
| Dosage form / route | Compliance anchor | Addition ratio basis | Process control point | Terminal product type |
|---|---|---|---|---|
| Subcutaneous 0.2-mL injection | USDA 9 CFR 113.330; Ph. Eur. 0589 | 1:200 v/v from 6.2 log10 PFU/mL bulk | 2–8°C hold, use ≤2 h | 1,000-dose vials plus 200-mL diluent bags |
| Frozen cell-associated −196°C | USDA 9 CFR 113.330; Ph. Eur. 0589 | 1×10^6–5×10^6 cells/mL in cryoprotectant | Thaw 25–37°C, ≤90 s | 1,000-dose ampoules or cryovials |
| Lyophilised plug | Ph. Eur. 0589; USP <921> | 1:125 v/v from 6.0 log10 PFU/mL bulk | Primary drying −35°C, residual moisture ≤2.0% w/w | 1,000-dose Type I glass vials |
| In-ovo 0.05-mL injection | USDA 9 CFR 113.330; WOAH Terrestrial Manual Chapter 2.3.13 | 1.0-mL ampoule at 1.5×10^6 PFU into 49 mL diluent | Viscosity 1.0–3.0 cP, 20,000–70,000 eggs/h | 50-mL injector-compatible bags |
In multivalent Marek's disease vaccines, FC-126 HVT is co-formulated with SB-1 or CVI988/Rispens using component-specific infectivity ratios rather than a single active-to-stabiliser ratio. A bivalent fill targeting 2,000 PFU of HVT and 1,500 PFU of SB-1 per 0.2-mL dose requires pre-dilution of each monovalent bulk based on measured plaque titre; for example, HVT at 6.4 log10 PFU/mL is added at 1:250 v/v and SB-1 at 5.8 log10 PFU/mL at 1:100 v/v into the final stabiliser, but these ratios shift with each bulk harvest. Downstream blending occurs in closed stainless steel vessels with low-shear agitation to avoid loss of cell-associated infectivity. The stabiliser system contains 5.0% w/v sucrose, 1.0% w/v hydrolysed gelatin, and 0.2% w/v potassium phosphate; the blend is filled as 1,000-dose vials and stored at −196°C. Compliance is verified by differential serotype-specific plaque assays and sterility testing under USDA 9 CFR 113.330 and Ph. Eur. 0589. Terminal finished products are bivalent frozen cell-associated vaccines and trivalent formulations containing CVI988/SB-1/HVT. Published data for FC-126-specific trivalent stabiliser limits is limited.
Across large hatchery operations, dilution logistics for FC-126-based suspensions use integrated cold-chain workstations where frozen or lyophilised API is reconstituted in 200-mL, 500-mL, and 1,000-mL diluent bags. The dilution ratio is governed by final dose volume and infectivity: one 1,000-dose lyophilised vial containing 1.5×10^6 PFU is reconstituted in 200 mL diluent to give 7.5×10^3 PFU/mL, sufficient for 1,500 PFU per 0.2-mL dose. Downstream production includes sterile docking of monodose bags, 2–8°C jacketed transfer lines, and in-line turbidity sensors calibrated to reject dilutions with visible precipitation or particulates after 6 h. Compliance references cold-chain validation under USDA 9 CFR 113.330 and stability provisions in Ph. Eur. 0589; distribution shippers must maintain internal temperature at 2–8°C for liquid forms or −196°C for frozen cell-associated forms. Terminal products are hatchery kits containing vaccine ampoules, twin 200-mL diluent bottles, transfer spikes, and injection-line tubing sets. This segment does not produce tablets, granules, premixes, or oral powders; live HVT infectivity cannot survive tabletting shear or gastric passage.
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Designated as Veterinary Grade API, Marek’s Disease Vaccine, Live (Strain FC-126) is a replication-competent Meleagrid alphaherpesvirus 1, more commonly designated turkey herpesvirus serotype 3. The strain code FC-126 identifies the master seed lineage rather than a chemically defined molecule. The live viral API is released as either a cell-associated cryopreserved suspension or a cell-free lyophilized plug. Trade documentation lists the possible carrier categories as tablets, injections, capsules, powders, granules, premix, and solutions; however, the viable biological form is suited only to injectable or in ovo diluent presentation. Tablets, capsules, and dry premix classifications are not appropriate final dosage forms for live FC-126 because compression shear, desiccation, and gastric transit would reduce infectious titre below the protective threshold. The API is intended solely for downstream formulation into sterile injectable solutions, in ovo injection diluents, or lyophilized stabilizer blends for further dilution.
Identity is established by monoclonal antibody fluorescent antibody test or polymerase chain reaction specific for HVT sequences, with absence of cross-reaction against serotype 1 and serotype 2 Marek’s disease viruses. Infectious titre is quantified by plaque assay on primary chicken embryo fibroblast monolayers under agar overlay and is reported as plaque-forming units per dose or per millilitre. The final unit dose titre is not universal and must be read from the manufacturer’s certificate of analysis; registered HVT monovalent products commonly reference a minimum protective titre in the range of 1,000–3,000 PFU per 0.2 mL dose, but the exact release figure is licence-specific. Bacterial and fungal sterility is assessed using Ph. Eur. 2.6.1 or USP <71>. Mycoplasma absence is evaluated by Ph. Eur. 2.6.7. Extraneous viral agents are controlled according to the USDA 9 CFR 113.330 family of requirements and the relevant regional registration dossier. For lyophilized cell-free API, residual moisture is controlled by Karl Fischer titration using USP <921> or Ph. Eur. 2.5.12; for cell-associated API, the critical release parameters include post-thaw viability, cryoprotectant concentration, and maintenance of liquid nitrogen temperature throughout storage.
At hatchery-level vaccination, FC-126 is most often formulated as an injectable solution after thawing the cell-associated API or reconstituting the lyophilized cell-free API. The final product is administered subcutaneously at day-old or by in ovo injection at day 18–19 of embryonation. In comparison with attenuated serotype 1 vaccines, FC-126 lacks oncogenic potential in chickens and can be used as the serotype 3 component in bivalent protocols with SB-1 to broaden protection against very virulent Marek’s disease virus. It is not interchangeable with CVI988/Rispens in monovalent high-challenge programs; published protection indices indicate that HVT alone provides a narrower protective window against very virulent pathotypes. The chosen physical form determines the cold-chain configuration. Cell-associated suspension requires storage in vapour-phase liquid nitrogen at -196 °C, while cell-free lyophilized powder is held at 2–8 °C before reconstitution.
In polyvalent Marek’s disease vaccines, FC-126 is manufactured separately, released against its own titre specification, and then blended with SB-1 or CVI988/Rispens under aseptic conditions. Bivalent HVT plus SB-1 formulations rely on the serotype 2 strain to compensate for the limited protective breadth of HVT alone. Trivalent products containing HVT, SB-1, and CVI988 are used where very virulent Marek’s disease virus pressure is high. No universal blend ratio exists; each manufacturer’s approved outline of production defines the contribution of each strain in plaque-forming units per dose. During blending, cell-associated APIs must be maintained at 0–8 °C and the final filled vials must be returned to liquid nitrogen storage. The addition of serotype 2 or attenuated serotype 1 components does not eliminate the need for early vaccination because maternal antibody interference and early challenge can reduce vaccine take. Equipment used for blending must be qualified for viability preservation, particularly when peristaltic pumps create shear stress on infected cells.
Aseptic filling of FC-126 API into vials is performed on automated filling lines using single-use tubing, vented needles, and chilled filling manifolds. Peristaltic pumping can reduce cell-associated viability; therefore, process qualification includes viral titre before and after filling. For lyophilized cell-free API, the lyophilization cycle must keep product temperature below the collapse temperature of the stabilizer matrix. Primary drying shelf temperature is commonly held below -20 °C, followed by secondary drying at 20–25 °C under controlled vacuum. Exact cycle parameters are proprietary and vary with vial size, fill volume, and stabilizer composition. Product contact surfaces must be free of quaternary ammonium residues, oxidizing agents, and extreme pH residues because the enveloped HVT particle is susceptible to inactivation by detergents and acidic or alkaline conditions. After removal from liquid nitrogen, cell-associated bags are thawed in a water bath at 25–35 °C and then held on ice until dilution. The holding time after thaw is manufacturer-validated and commonly does not exceed 2 hours at 0–8 °C. Lyophilized API after reconstitution is used within 2 hours and is not refrozen.
Cell-associated FC-126 API is transported and stored in vapour-phase liquid nitrogen. Exposure to temperatures above -140 °C during repeated retrieval can cause loss of cell viability and reduce infectious titre. Freeze-thaw cycling is limited to a single thaw prior to use. Lyophilized cell-free API is stored at 2–8 °C and must be protected from direct light. Over-drying of powder or granular intermediates below the stabilizer requirement can damage the viral envelope; therefore, desiccant selection in secondary packaging is controlled. Reconstituted vaccine must not be combined with diluents containing preservatives unless specifically validated, because preservatives such as chlorhexidine or high concentrations of certain surfactants can rapidly reduce HVT infectivity. Unused constituted product is discarded as biohazardous waste in accordance with regional veterinary biological disposal rules.
FC-126 is a turkey herpesvirus and is antigenically related to Marek’s disease virus but does not induce Marek’s disease in chickens. This distinguishes it from attenuated serotype 1 strains such as CVI988/Rispens, which require more stringent containment and have higher protective capability against very virulent field isolates. The table below summarizes the principal distinctions.
| Strain | Species origin | MDV serotype | Oncogenic potential in chickens | Primary field role | Common physical form |
|---|---|---|---|---|---|
| FC-126 | Turkey | 3 | Non-oncogenic | Monovalent, bivalent with SB-1, HVT vector backbone | Cell-associated cryopreserved or cell-free lyophilized |
| SB-1 | Chicken | 2 | Non-oncogenic | Bivalent with HVT for broader protection | Cell-associated cryopreserved |
| CVI988/Rispens | Chicken | 1 | Attenuated | Monovalent or trivalent against very virulent MDV | Cell-associated cryopreserved |
FC-126 also serves as the parent backbone for recombinant HVT vector vaccines carrying insertions for Newcastle disease virus, infectious laryngotracheitis virus, and other poultry pathogens. The plain FC-126 API contains no foreign gene insert. Published direct comparative data for every possible field challenge model is limited, so strain selection is based on serotype coverage, challenge pathotype, and manufacturer-validated potency. The operational boundary for FC-126 is defined by its lack of oncogenicity, its compatibility with serotype 2 and attenuated serotype 1 partners, and its requirement for strict low-temperature handling when supplied as a cell-associated suspension.
