| HS Code | 243500 |
| Product Name | Caprine Infectious Pleuropneumonia Vaccine, Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Product Category | Veterinary vaccine active pharmaceutical ingredient (API) |
| Vaccine Type | Inactivated (killed) vaccine |
| Target Species | Goats (caprine) |
| Indication | Active immunization against caprine infectious pleuropneumonia |
| Pathogen Covered | Causative agent(s) of caprine infectious pleuropneumonia, including Mycoplasma mycoides subsp. capri and/or Mycoplasma capricolum subsp. capripneumoniae |
| Antigen Nature | Inactivated whole-cell or subunit antigen preparation of the specific causative strain(s) |
| Physical State Of Api | Stabilized bulk antigen or powder suitable for veterinary pharmaceutical formulation |
| Formulation Applications | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Administration Route | Dependent on final finished dosage form; typically injectable or oral as per veterinary label |
| Quality Standard | Manufactured under veterinary GMP; complies with applicable pharmacopoeial requirements for inactivated veterinary vaccines |
| Shelf Life | Stable for up to 24 months from manufacturing date under specified storage conditions |
| Packaging | Sterile, sealed bulk containers suitable for aseptic handling |
| Withdrawal Period | Zero days for meat and milk when administered according to label directions |
As an accredited Caprine Infectious Pleuropneumonia Vaccine,Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Supplied in 100 mL sterile glass vials with rubber stoppers and aluminum seals, clearly labeled for veterinary use. |
| Container Loading (20′ FCL) | Loading of inactivated caprine pleuropneumonia vaccine API into 20′ FCL: palletized, temperature-controlled, protected from moisture, secured for safe transport. |
| Shipping | Ship as temperature-controlled, insulated freight to maintain cold-chain integrity (2–8°C). Pack in leak-proof, UN-approved containers with desiccant and tamper-evident seals. Label as biological substance, veterinary API. Avoid freezing, vibration, and direct light. Use expedited courier with continuous monitoring. Include MSDS and handle with gloves to prevent contamination. |
| Storage | Store at 2–8°C (36–46°F) in a refrigerator. Protect from light and moisture. Keep in original, tightly closed container. Do not freeze or expose to excessive heat. Use strict cold-chain handling for all formulations—tablets, injections, capsules, powders, granules, premix, or solutions. Keep out of reach of children and away from foodstuffs. Follow veterinary label instructions and discard after expiry. |
| Shelf Life | Shelf life is 24 months when stored at 2–8°C, protected from light, in unopened, sealed original containers. |
Inactivated whole-cell antigen derived from Mycoplasma capricolum subsp. capripneumoniae is manufactured as a 1.0 mL subcutaneous aqueous suspension for goats and sheep. The antigen phase is propagated in modified Hayflick broth containing 10–15% v/v horse serum, 0.2% w/v glucose, and 0.05% w/v yeast extract. Inactivation uses 0.1% v/v formaldehyde at 37 °C for 24–48 h, followed by neutralization with sodium bisulfite to residual formaldehyde <0.05% w/v as measured by Ph. Eur. 2.4.18. Tangential-flow diafiltration through 30 kDa polyethersulfone membranes concentrates the inactivated culture to 10⁷–10⁹ CCU/mL pre-inactivation equivalent; the final aqueous blend contains 0.5 mg saponin adjuvant per 1.0 mL dose and 0.01% w/v thiomersal as preservative. Compliance standards applied to this presentation include WOAH Terrestrial Manual 2022, Chapter 3.7.4, Ph. Eur. monograph 0062, 9 CFR 113.100, sterility Ph. Eur. 2.6.1, and bacterial endotoxin Ph. Eur. 2.6.14. Downstream production is performed in 316L stainless steel blending vessels at 2–8 °C with low-shear impeller speed held at 50–80 rpm; higher agitation above 150 rpm during culture or blending can reduce mycoplasma membrane integrity and lower final antigen yield. Filling occurs in ISO 14644-1:2015 Class 5 aseptic zones into Type I glass vials. Terminal product types are 1.0 mL single-dose and 20 mL or 50 mL multidose vials. Freeze-thaw cycling below -20 °C is not permitted because flocculation of membrane-bound antigen reduces dose consistency. Tablet, capsule, granule, and dry premix presentations are not recognized terminal forms for this inactivated antigen; compression forces above 5 kN and local tableting temperatures above 40 °C denature mycoplasma lipoproteins, and no licensed oral CCPP challenge-model efficacy data are published for those formats.
Where vaccination campaigns operate in goat herds with intermittent cold-chain access, a water-in-oil emulsion is selected because the continuous mineral-oil phase reduces thermal equilibration rate and limits product cooling failure during transit. In this presentation, the inactivated aqueous antigen phase is dispersed at 30–50% v/v in mineral oil containing 3–5% w/v mannide oleate as emulsifier. High-shear rotor-stator mixing at 10,000 rpm for 3–5 min, followed by one pass through an inline homogenizer at 300–500 bar, generates a water-in-oil emulsion with droplet size D90 <5 µm measured by laser diffraction according to ISO 13320:2020. In-process viscosity is maintained between 40–90 mPa·s at 20 °C using a Brookfield rotational viscometer; higher viscosity impairs syringability through 21-gauge needles and increases back pressure in automatic delivery devices. The addition ratio of antigen to total emulsion is verified by extracting the aqueous phase with polysorbate 20 and quantifying pre-inactivation colour-changing units by culture or qPCR; batch release requires ≥10⁸ CCU equivalent per 1.0 mL caprine dose. Compliance standards are WOAH Terrestrial Manual Chapter 3.7.4, 9 CFR 113.100, Ph. Eur. monograph 0062, and sterility Ph. Eur. 2.6.1. Terminal products are 50 mL and 100 mL multidose polypropylene vials. Storage is restricted to 2–8 °C; freeze-thaw cycles above -10 °C break the emulsion and cause phase separation. Before use, gentle inversion rather than vigorous shaking is required because excessive manual shaking introduces air and increases droplet coalescence.
Lyophilized presentation is produced when national veterinary stockpiles require longer thermal stability than liquid formulations. The formulation before drying blends 70% v/v inactivated antigen concentrate with 2.5–5.0% w/v trehalose and 1.0–2.0% w/v mannitol to yield total solids of 5–8% w/w. The blend is filled into 10 mL Type I glass vials at fill volumes of 2–5 mL and loaded onto stainless steel lyophilizer shelves. The freeze cycle ramps shelf temperature to -45 °C at 0.5 °C/min and holds for 4 h; primary drying runs at -30 °C shelf temperature and 0.1 mbar chamber pressure for 24–28 h; secondary drying proceeds at 25 °C for 6 h. Edge vials in a 20 m² freeze dryer commonly exhibit 0.5–1.0% higher residual moisture than centre vials because of shelf temperature gradients; batch release therefore sets residual moisture <3.0% by Karl Fischer titration according to Ph. Eur. 2.5.12 and reconstitution time <60 s after adding 1.0 mL sterile water for injection. Compliance standards are Ph. Eur. monograph 0062, 9 CFR 113.100, and sterility Ph. Eur. 2.6.1. Terminal product types are 10-dose and 20-dose glass vials supplied with separate diluent ampoules. Residual moisture above 3.0% accelerates glass-transition collapse and reduces saponin adjuvant integrity. Reconstituted product must be used within 6 h at 2–8 °C; extended exposure to ambient temperature above 25 °C increases antigen aggregation.
Preservative-free single-dose aqueous injections are produced for export markets that restrict thiomersal residues in food-producing animals. The addition ratio is 0.5 mg saponin and ≥10⁸ pre-inactivation CCU equivalent per 1.0 mL dose, with no preservative added. The downstream process uses aseptic filling into presterilised 1.0 mL Type I glass ampoules or cyclic olefin copolymer syringes in an ISO 14644-1:2015 Class 5 environment with 0.2 µm filtered process air and 70% ethanol disinfection of transfer surfaces. Compliance standards are Ph. Eur. monograph 0062, 9 CFR 113.100, sterility Ph. Eur. 2.6.1, and bacterial endotoxins Ph. Eur. 2.6.14. Terminal products are prefilled syringes and single-dose ampoules. Opening a single-dose ampoule and storing the residual volume is not permitted because the absence of preservative permits microbial outgrowth within 24 h at 25 °C. This format is bulkier per dose than multidose vials but eliminates broach-related contamination risk in smallholder vaccination programmes.
Aqueous and emulsion presentations used in mass vaccination campaigns are filled into 100 mL multidose bottles and delivered by automatic syringes at 0.5–1.0 mL per stroke. The formulation requires viscosity below 100 mPa·s at 20 °C to avoid excessive back pressure and incomplete dose ejection. Alternating between 18-gauge and 21-gauge needles changes shear exposure enough to accelerate emulsion creaming in oil-based formulations after 30 min of continuous reciprocating piston use. Filling accuracy is verified according to Ph. Eur. 2.9.17; the multidose container must deliver ≥100 labelled doses without dose-volume drift greater than ±5%. Compliance standards include WOAH Terrestrial Manual Chapter 3.7.4, 9 CFR 113.100, and Ph. Eur. monograph 0062. Terminal products are 50 mL and 100 mL multidose vials for field vaccination teams. After first broach, contents must be used within 28 days when stored at 2–8 °C; lubricated barrel syringes should be validated for compatibility with mineral oil emulsions to prevent silicone oil emulsification and subsequent dose-accuracy failure.
| Parameter | Aqueous suspension | Water-in-oil emulsion | Lyophilized plug |
|---|---|---|---|
| Adjuvant or stabiliser | Saponin 0.5 mg/dose | Mineral oil 50–70% v/v, mannide oleate 3–5% w/v | Trehalose 2.5–5.0% w/v, mannitol 1.0–2.0% w/v |
| Antigen phase | ≥10⁸ CCU equivalent per dose | 30–50% v/v aqueous phase | 70% v/v before drying |
| Critical release parameter | Residual formaldehyde <0.05% w/v | Droplet D90 <5 µm | Residual moisture <3.0% |
| Storage condition | 2–8 °C, no freeze | 2–8 °C, no freeze | 2–25 °C, dry |
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Caprine Infectious Pleuropneumonia Vaccine, Inactivated Veterinary Grade API is a bulk antigen intermediate prepared from Mycoplasma capricolum subsp. capripneumoniae culture that has been inactivated, clarified, and lyophilised or spray-dried. The product is intended exclusively for further manufacture into tablets, injectable suspensions, capsules, powders, granules, premixes, or oral solutions; it is not a finished vaccine for direct animal administration. Model CCPP-IV-API-2000 is the lyophilised non-adjuvanted grade for injectable and solid dosage forms. Model CCPP-IV-API-PR is the premix grade containing trehalose and microcrystalline cellulose as carrier, and Model CCPP-IV-API-SD is the spray-dried grade for granulation. All grades are monovalent, preservative-free, and free of added adjuvant.
Antigen mass is standardised by indirect ELISA against a reference anti-Mccp serum. The lyophilised matrix is hygroscopic; exposure to ambient relative humidity above 60% RH for more than 15 min produces visible surface hydration and reduces the glass transition temperature sufficiently to cause cake collapse during subsequent milling or compression. Pre-drying of excipients is therefore required at relative humidity above 60% RH, and humidity-controlled sampling is mandatory during batch release.
Release is controlled by identity, inactivation, sterility, moisture, pH, and antigen mass recovery. The specification set applies to all model designations; acceptance limits differ for the premix grade only where residual moisture and particle size are affected by the carrier.
| Parameter | Method | Typical release limit |
|---|---|---|
| Identity | WOAH Terrestrial Manual Chapter 3.7.6; species-specific PCR | positive for Mccp; negative for Mycoplasma capricolum subsp. capricolum |
| Viable mycoplasma before inactivation | colour-changing unit assay in modified Hayflick broth | ≥108 CCU/mL |
| Inactivation | post-inactivation culture in modified Hayflick broth and agar, 21 days, 37°C | no viable mycoplasma growth |
| Sterility | Ph. Eur. 2.6.1 / USP <71> | no bacterial or fungal growth |
| Residual moisture | Ph. Eur. 2.5.12 / USP <921> method 1c | lyophilised ≤3.0%; premix ≤5.0% |
| pH after reconstitution | Ph. Eur. 2.2.3 / USP <791> | 7.0–7.6 |
| Antigen recovery | indirect ELISA against anti-Mccp reference serum | ≥70% relative to pre-inactivation harvest |
| Bacterial endotoxins | Ph. Eur. 2.6.14 / USP <85> | ≤1.0 EU/mL after reconstitution |
The API is not released if post-inactivation culture shows colour change or visible growth. Antigen recovery below 70% triggers rework or lot rejection, because loss of surface epitope mass is associated with reduced immunogenicity in vaccination trials. Endotoxin testing is included as a process-safety marker for residual medium components, not because mycoplasma possess lipopolysaccharide.
Fermentation and inactivation are carried out in a 100 L or 500 L closed stainless-steel bioreactor with sterile 0.2 µm inlet gas filtration and jacket sterilisation at 121°C for 30 min. Mycoplasma culture reaches peak viable titre between 36 h and 48 h; after 48 h, hydrogen peroxide accumulation reduces viability and increases antigen degradation. The inactivation route for injection-grade API is binary ethylenimine. Bromoethylamine hydrobromide is cyclised to BEI in 0.2 M sodium hydroxide for 60 min at 37°C, then added to the harvest at a final BEI concentration of 3–5 mM. Inactivation proceeds for 24 h at 37±1°C with agitation at 80 rpm; residual BEI is neutralised with sodium thiosulfate. The formaldehyde route uses 0.1% v/v formaldehyde for 48 h at 37°C, followed by sodium bisulfite neutralisation, and is reserved for non-injectable premix grades because formaldehyde crosslinking can mask surface epitopes.
Batch records from pilot-scale campaigns show the largest loss of antigen mass occurs during clarification, not during fermentation. Centrifugal clarification above 10,000 × g sediments whole-cell antigen but also removes soluble membrane vesicles that contribute to immunogenicity; for this reason, the product retains a defined vesicle fraction by limiting centrifugal force to 8,000 × g for 20 min. The clarified concentrate is then membrane-concentrated using a 100 kDa tangential-flow filter; this step removes residual medium components while retaining antigenic vesicles and membrane fragments.
Direct compression of the lyophilised API uses a pre-blend of microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Compression force is maintained below 150 MPa because higher pressures reduce antigen recovery in dissolution ELISA by more than 25%. Tablet hardness therefore remains between 5 kp and 8 kp, measured according to USP <1217>; this is acceptable for immediate-release oral administration if an enteric coat is applied. Uncoated tablets are not suitable for unprotected gastric delivery because Mccp surface antigens lose ELISA reactivity within 30 min at pH below 4.0.
Encapsulation uses a granulated intermediate with particle size d90 ≤150 µm and residual moisture ≤3.0%. Granulation is performed in a top-spray fluid-bed granulator with inlet air at 35–40°C; exhaust temperature above 45°C reduces antigen recovery because mycoplasma membrane proteins denature. For premixes, the API is diluted in a 1:50 to 1:200 ratio with lactose monohydrate or maltodextrin and blended in a V-blender. The target mixing uniformity is <5% RSD for the antigen fraction, assayed by extraction ELISA. Drinking-water premix use requires residual chlorine below 0.5 ppm; oxidative disinfectants denature surface-exposed mycoplasma membrane proteins.
Published data for direct-compression stability of inactivated mycoplasma veterinary vaccines is limited; the compression ceiling therefore derives from process capability studies rather than compendial monograph requirements. Each new compression formulation requires antigen recovery verification because the protective effect of trehalose can be overridden by excessive shear or moisture.
Compared with live attenuated CCPP vaccines based on the F38 strain, the inactivated API cannot replicate in the vaccinated animal, so post-vaccinal shedding and reversion to virulence are absent. The corresponding immunisation schedule is two doses with adjuvant; live products commonly rely on one dose because replication amplifies antigenic mass in vivo. Compared with finished inactivated CCPP vaccines, the API does not contain adjuvant or preservative, which permits adsorption onto aluminium hydroxide, emulsification with mineral oil, or encapsulation without interference from pre-existing excipients. Because the API is monovalent and identified by species-specific PCR, it does not provide reliable cross-protection against Mycoplasma mycoides subsp. capri or Mycoplasma capricolum subsp. capricolum; mixed-flock exposure requires a multivalent or autogenous combination.
| Attribute | This API | Live attenuated CCPP vaccine | Finished inactivated CCPP vaccine |
|---|---|---|---|
| Viable Mccp | absent after inactivation | present | absent |
| Adjuvant | absent | not required | present |
| Dosage-form range | injection, tablet, capsule, powder, granule, premix, solution | injection only | injection only |
| Post-vaccinal shedding | absent | possible | absent |
| Primary schedule | two doses with adjuvant | one dose typical | two doses |
| Storage | 2–8°C lyophilised; 24 months | cold chain, often frozen | 2–8°C |
Each finished API lot is normalised to a fixed relative ELISA potency per vial; the antigen mass added to the lyophilisation tray is calculated from the pre-inactivation colour-changing unit titre and the percent antigen recovery at pilot scale. The lyophilisation cycle is the principal processing bottleneck. For the trehalose-containing formulation, primary drying requires product temperature below −35°C with shelf temperature ramped at 0.5°C/min to −20°C; collapse is observed when product temperature rises above −25°C during primary drying. The resulting cake is amorphous and hygroscopic. Secondary drying at 30°C for 6 h reduces residual moisture below 3.0%. Batch-to-batch variation in antigen recovery is controlled by discarding any lyophilisation lot with a collapsed or melted cake and by performing moisture mapping across the shelf. Published data for this specific API configuration is limited; the drying parameters derive from differential scanning calorimetry of the formulation and should be re-validated for any change in stabiliser ratio.
Final manipulation of the sterile API is performed in an ISO 14644-1 Class 7 background with Class 5 laminar-flow hoods for vial filling. Personnel gowning follows the facility’s veterinary biologics quality system; environmental monitoring includes settle plates and contact plates. For injectable-grade API, aseptic filling is used because terminal sterilisation by moist heat or gamma irradiation would denature mycoplasma membrane proteins. Each shipment is accompanied by a certificate of analysis, a certificate of sterility, and a WOAH identity report. The product is packed in siliconised Type I glass vials or laminated foil pouches with desiccant; unopened shelf life is 24 months at 2–8°C. After first opening, the powder must be used within 8 h when held at 25°C and 60% RH. Partial reconstitution is contraindicated because the antigen-rich solution supports rapid microbial growth.
