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Purified Inactivated Rabies Vaccine For Human Protection

As a trusted global supplier of Purified Inactivated Rabies Vaccine For Human Protection, AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. combines a robust Vero cell platform with multi‑step chromatographic purification to produce an inactivated vaccine that meets stringent international pharmacopoeial standards. Manufactured entirely in B+A grade cleanrooms and formulated without any preservatives or antibiotics, each vial contains at least 2.5 IU of inactivated rabies virus antigen, ensuring consistent immunogenic performance for both pre‑exposure prophylaxis in at‑risk occupations and post‑exposure management after suspected rabid animal contact.

Product Overview

The Purified Inactivated Rabies Vaccine For Human Protection is presented as a white crisp cake that, upon reconstitution with the supplied sterile water for injection, forms a clear, colorless liquid ready for intramuscular administration. The formulation relies on high‑purity inactivated rabies fixed virus (aGV strain) to induce neutralizing antibodies without the addition of preservatives or antibiotics. The table below summarizes its key compositional and physical parameters.

Parameter Specification
Active Ingredient Inactivated rabies fixed virus (aGV strain)
Cell Substrate Vero cells
Excipients 1% human albumin, 1% gelatin, 5% sucrose, PBS
Diluent Sterile water for injection, 1.0ml per vial
Dosage Form Lyophilized powder for intramuscular injection
Volume per Vial 1.0ml after reconstitution
Potency ≥2.5 IU per single human dose
Appearance (Pre-reconstitution) White crisp cake
Appearance (Post-reconstitution) Clear, colorless liquid
Preservatives None
Antibiotics None
Storage Condition +2°C to +8°C, protected from light
Shelf Life 36 months
Packaging 1 vial vaccine + 1 vial sterile water for injection per single human dose

1. Lyophilized Format: The freeze‑dried cake preserves antigen activity for 36 months under routine refrigeration, supporting flexible stockpile management and easy shipment.

2. Preservative‑Free Composition: Without preservatives or antibiotics, the vaccine minimizes the potential for hypersensitivity and is well tolerated across all indicated age groups.

3. Broad Indication Profile: Approved for both pre‑exposure and post‑exposure prophylaxis, the vaccine covers everyone from occupational risk groups to the general population following an animal bite.

Together, these characteristics make the Purified Inactivated Rabies Vaccine in a practical and safe choice for national immunization programs and emergency response stockpiles alike.

Purification & Potency

AIM Honor applies a sequence of advanced downstream processes to guarantee that every vial of Purified Inactivated Rabies Vaccine delivers high antigenic purity and consistent potency. After virus cultivation in Vero cells and complete inactivation, the suspension is concentrated and polished to remove impurities while preserving the immunogenic epitopes required for rapid seroconversion.

1. Ultrafiltration Concentration: A 20m² ultrafiltration system concentrates the inactivated virus and eliminates low‑molecular‑weight impurities, providing a clean starting material for chromatography.

2. Chromatographic Polishing: The concentrated suspension passes through a 600mm chromatography column that selectively retains intact viral particles, effectively removing residual host‑cell proteins and DNA.

3. Controlled Lyophilization: Purified bulk is formulated with stabilizers and dried in a 40m² freeze‑drying system under strictly controlled parameters, locking in potency without the need for preservatives.

4. Potency Verification: Each batch is tested to confirm a minimum potency of 2.5 IU per dose, ensuring robust immunogenicity that meets or exceeds international pharmacopoeial requirements.

This rigorous purification cascade consistently yields an inactivated vaccine with low endotoxin levels (≤10 EU/dose) and reliable batch‑to‑batch uniformity, providing confidence for both clinicians and procurement agencies.

Indications & Schedule

The Purified Inactivated Rabies Vaccine is indicated for anyone requiring reliable immunization against rabies virus. Its standardized intramuscular regimen simplifies administration across diverse healthcare settings, from urban hospitals to rural clinics.

1. Post‑Exposure Prophylaxis: Following immediate and thorough wound cleansing, five doses are administered on days 0, 3, 7, 14, and 28. The first dose may be doubled in elderly, immunocompromised, or delayed‑presentation cases to strengthen the early immune response.

2. Pre‑Exposure Prophylaxis: Three doses given on days 0, 7, and 21 or 28 provide baseline immunity for veterinarians, animal handlers, forestry workers, slaughterhouse staff, and laboratory personnel.

3. Category III Exposure Management: For severe exposures involving bleeding wounds or mucous membrane contamination, rabies immunoglobulin (20 IU/kg) or antiserum (40 IU/kg) is infiltrated around the wound concurrently with the first vaccine dose.

4. Re‑Immunization Guidance: Previously vaccinated individuals exposed again within one year receive two booster doses on days 0 and 3; beyond one year, a full five‑dose series is recommended.

Adhering to these schedules enables healthcare providers to achieve a 100% seroconversion rate within 14 days, offering timely, life‑saving protection in every indicated scenario.

Quality Assurance

AIM Honor’s quality framework for the Purified Inactivated Rabies Vaccine For Human Protection is built around international GMP compliance and internal standards that are stricter than national pharmacopoeia benchmarks. Every production step, from cell banking to final packaging, is monitored and documented to guarantee product integrity.

1. B+A Grade Cleanrooms: All open manipulations, including strain passage and filling, take place in B+A grade environments with personnel in fully enclosed protective suits to maintain sterility.

2. Closed Sterile Systems: Virus propagation and bacterial culture are performed in fully closed systems, eliminating cross‑contamination risks and preserving biological consistency.

3. Multi‑Point Release Testing: Every batch undergoes potency, sterility, endotoxin (≤10 EU/dose), and pH testing, with stability monitoring continued throughout the assigned 36‑month shelf life.

4. Domestically Developed aGV Strain: The high‑yield aGV strain, fully characterized and banked under GMP conditions, ensures consistent antigenic performance and reliable manufacturing scalability.

This uncompromising approach to quality means that every vial of Purified Inactivated Rabies Vaccine can be deployed with full confidence in its safety, purity, and prophylactic power.

Global Supply

As a direct factory supplier, AIM Honor supports bulk procurement and cross‑border logistics for the Purified Inactivated Rabies Vaccine, helping national health systems and international organizations maintain uninterrupted access to high‑quality rabies prophylaxis.

1. Bulk Ordering: Direct engagement with the manufacturer secures competitive pricing, reserved batch allocations, and stable lead times for large‑volume tenders.

2. Validated Cold Chain: Temperature‑controlled packaging with real‑time data loggers maintains the required +2°C to +8°C range from factory loading through final delivery, protecting antigen potency.

3. Regulatory Documentation: Complete dossiers, including certificates of analysis, GMP statements, and stability summaries, are provided with each shipment to facilitate customs clearance and product registration.

4. Sample Evaluation: Qualified institutional buyers can request evaluation samples to perform local quality assessments and accelerate the registration process before committing to volume purchases.

With dedicated export support and scalable manufacturing capacity, AIM Honor ensures that the Purified Inactivated Rabies Vaccine For Human Protection reaches the communities that need it most, reliably and affordably.

FAQ

Q: What is the shelf life of this purified inactivated rabies vaccine?

A: The vaccine has a shelf life of 36 months when stored and transported continuously between +2°C and +8°C, protected from light. Maintaining an unbroken cold chain throughout distribution is essential to preserve the potency and immunogenicity of the lyophilized product until the moment of reconstitution.

Q: Does this vaccine contain any preservatives or antibiotics?

A: No, this inactivated vaccine is completely free of preservatives and antibiotics. The excipients are limited to 1% human albumin, 1% gelatin, and 5% sucrose, used solely as stabilizers to protect the antigen during freeze‑drying and storage, which significantly reduces the risk of allergic reactions.

Q: How is the vaccine reconstituted and administered?

A: The lyophilized powder is reconstituted with the entire volume of the enclosed sterile water for injection and shaken until fully dissolved into a clear liquid. It is then administered immediately via intramuscular injection into the deltoid muscle for adults and older children, or into the anterolateral thigh for young children.

Q: Are there any contraindications for post‑exposure vaccination?

A: No. Because rabies is uniformly fatal once clinical signs develop, there are absolutely no contraindications for post‑exposure immunization. The vaccine must be given to every exposed individual regardless of age, pregnancy status, or underlying health conditions, with appropriate medical supervision when necessary.

Q: What quality tests are performed before release?

A: Each batch undergoes a comprehensive panel of release tests, including potency verification (≥2.5 IU/dose), sterility testing with zero microbial growth, endotoxin quantification (≤10 EU/dose), pH measurement, and visual inspection. Stability is also monitored periodically throughout the shelf life to confirm ongoing compliance.

Q: How can international buyers place a bulk order?

A: AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. welcomes bulk purchase inquiries from government health agencies, international organizations, and institutional buyers. Contact our export team through the official website to discuss order volumes, pricing, cold‑chain logistics, and the regulatory documentation needed for import into your country.

Partnership Value

Partnering with AIM Honor means choosing a manufacturer that integrates scientific rigour with operational reliability. Our vertically integrated production, from the domestically developed aGV strain to final lyophilization, gives us full control over quality and supply continuity, while our GMP‑certified facility and strict internal standards exceed national pharmacopoeia requirements.

1. Reliable Efficacy: Clinical performance backed by a 100% seroconversion rate within 14 days and a minimum potency of 2.5 IU per dose supports confident deployment in outbreak and routine settings.

2. Regulatory Preparedness: Comprehensive technical dossiers and batch‑specific documentation are available to accelerate product registration and tender participation in your market.

3. Long‑Term Support: From initial sample evaluation through repeated bulk shipments, our dedicated account team ensures responsive communication, technical consultation, and supply security.

Contact AIM Honor today to learn how the Purified Inactivated Rabies Vaccine For Human Protection can strengthen your rabies elimination strategy with a preparation grounded in purity, safety, and proven immune protection.

Purified Inactivated Rabies Vaccine For Human Protection  Purified Inactivated Rabies Vaccine For Human Protection

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