China Inactivated Anti-Hepatitis A Virus Vaccine For Human Immunization Manufacturer, Supplier, Factory

Inactivated Anti-Hepatitis A Virus Vaccine For Human Immunization, brought by AIM Honesty Biopharmaceutical Co., Ltd., a China vaccine manufacturer, is formulated with KMB17 human diploid cell substrate and Lv-8 virus strain, approved by NMPA with S20153002 for adult formulation. This inactivated vaccine is designed for human immunization to build active immunity against hepatitis A virus, supporting national and international public health procurement programs with stable antigen content and proven immunogenicity comparable to imported alternatives, suitable for bulk orders for public health institutions and vaccine distributors worldwide.

AIM Honesty Biopharmaceutical Co., Ltd., a China-based vaccine manufacturer under AIM Vaccine Group, supplies Inactivated Anti-Hepatitis A Virus Vaccine. This product adopts human diploid cell culture and formaldehyde inactivation technology, retaining sufficient immunogenicity while eliminating viral infectivity. It is an NMPA-approved biological product for human immunization, widely selected by health authorities, vaccine distributors and immunization programs to control HAV transmission across populations.

Product Profile

Inactivated Anti-Hepatitis A Virus Vaccine is an inactivated biological vaccine intended for active human immunization against hepatitis A virus infection. The vaccine is produced using the Lv-8 HAV strain cultivated on KMB17 human diploid cell substrate. After virus harvesting, the bulk suspension is processed through ultrafiltration, concentration and chromatographic purification steps. Formaldehyde inactivation removes viral replication capacity, then aluminum adjuvant is added to form a slightly milky white suspension. Gentle shaking can re-disperse sediment that may appear during storage. The product is available in separate pediatric and adult formulations to match different age groups’ immunization needs.

It targets susceptible populations aged 1 year and older. After intramuscular injection, the vaccine stimulates the human immune system to produce specific anti-HAV antibodies. These antibodies block hepatitis A virus invasion and lower the risk of symptomatic infection and community transmission. Unlike live attenuated vaccine options, this inactivated preparation carries no risk of viral reversion, making it easier for public health planners to deploy in routine and emergency immunization scenarios.

Core Technology

The manufacturing foundation of Inactivated Anti-Hepatitis A Virus Vaccine For Human Immunization relies on two core validated materials: the Lv-8 strain and KMB17 human diploid cell line. Both have accumulated decades of research data and real-world use history, forming the safety and immunogenicity base of the product.

1. Lv-8 strain: This HAV strain was isolated and screened during the 1988 hepatitis A outbreak in Shanghai, sourced from a patient in Lüsi Town, Jiangsu Province. It features short replication cycles, high virus yield, stable genetic characteristics and reliable immunogenic performance, protected by national patent rights.

2. KMB17 human diploid cell line: Independently established by Kunming Institute in 1974. This cell substrate has passed long-term safety validation. It avoids tumorigenicity and exogenous viral contamination risks associated with animal cell substrates, which is a key advantage for human vaccine production.

After cell culture and virus harvest, multiple purification steps remove host cell proteins, DNA and process impurities. Formaldehyde inactivation is performed under controlled temperature and concentration parameters to fully disable viral infectivity. Finished product batches go through full release testing before shipment, covering antigen content, sterility, residual formaldehyde, and safety indicators.

The production line has passed GMP certification, with dedicated cell factory and microcarrier fermentation equipment to support scalable bulk manufacturing for large procurement orders.

Specifications & Dosing

All dosage and administration guidance for Inactivated Anti-Hepatitis A Virus Vaccine follows the official product insert and NMPA requirements. Two separate formulations cover pediatric and adult use cases.

Important operational notes before administration: Shake the vaccine suspension thoroughly before use. It is strictly for intramuscular injection and cannot be administered intravenously. Healthcare practitioners should review recipient medical history for allergy risks before vaccination. Storage and cold chain transport must comply with specified temperature requirements to maintain vaccine stability.

Immune Performance

Inactivated Anti-Hepatitis A Virus Vaccine For Human Immunization achieves favorable immune response in both children and adults. Clinical comparison data shows its antibody seroconversion rate reaches a level comparable to imported inactivated hepatitis A vaccine products. The geometric mean titer GMT of induced anti-HAV antibodies demonstrates competitive performance against imported reference vaccines.

After completing the two-dose primary plus booster immunization schedule, vaccinated individuals develop sustained specific humoral immunity. This characteristic makes the vaccine suitable for routine immunization campaigns, pre-travel prophylaxis, and outbreak response plans where population-level immune protection is required. Antibody levels will gradually persist over time, reducing the probability of severe hepatitis A illness upon exposure to HAV.

Immunogenicity consistency between batches is maintained by tightly controlled upstream cell culture, virus harvest and purification processes. Batch release testing verifies antigen quantity and quality indicators for every production run, supporting reliable supply for large-scale public health tenders.

Quality Assurance

AIM Honesty Biopharmaceutical builds full-cycle quality control for Inactivated Anti-Hepatitis A Virus Vaccine from raw material incoming inspection to finished batch release and post-market monitoring. The manufacturing facility holds national GMP certification for vaccine production. The adult formulation has obtained NMPA marketing approval under registration number S20153002, while the pediatric formulation carries approval number S20153004.

1. Raw material verification: Cell bank, virus seed bank, adjuvant and excipient materials are all stored under controlled conditions with complete traceability records.

2. In-process testing: Sampling is performed at each production stage, including cell culture monitoring, virus titer detection, impurity testing and inactivation validation to confirm complete loss of viral infectivity.

3. Finished product release: Each batch undergoes a full panel of tests including antigen content, sterility, abnormal toxicity, residual formaldehyde and physical property inspection before release.

4. Post-market surveillance: The company maintains pharmacovigilance systems to collect adverse event information and conduct continuous safety review after product distribution.

As part of AIM Vaccine Group, the company maintains independent research institutes and R&D centers. The group regularly participates in international pharmaceutical exhibitions such as CPHI Shanghai and CPHI Europe, communicating with global public health buyers and regulatory stakeholders on vaccine quality standards and supply requirements.

Packing & Logistics

Biological vaccine products have strict cold chain requirements, and Inactivated Anti-Hepatitis A Virus Vaccine For Human Immunization must be kept under specified refrigerated conditions during storage and international shipment. Our team designs export-ready packaging configurations to stabilize temperature during long sea or air transport.

Packaging options include single-dose pre-filled syringes and vial formats. Outer cartons carry full product information, batch numbers, expiry dates and regulatory marking required for customs clearance and national health authority documentation. We can provide supporting documents including batch release certificates, GMP documentation and commercial invoices for tender and import registration procedures.

Our international business team coordinates cold chain logistics partners. Buyers can consult our team for lead time, MOQ, documentation packages and shipping quotation for bulk procurement. All packing workflows follow biological cargo shipping standards to minimize temperature deviation risks in transit.

FAQ

Q: What population is eligible for Inactivated Anti-Hepatitis A Virus Vaccine?

A: This vaccine is intended for susceptible people aged 1 year and older. Separate pediatric and adult formulations are provided for different age brackets: recipients from 1 up to 15 years of age use the 0.5 mL formulation, and individuals older than 15 years use the 1.0 mL formulation. People with known severe allergic reactions to vaccine components cannot receive this immunization product. Medical assessment should be completed for recipients with acute illness or uncontrolled chronic conditions before vaccination.

Q: What is the full immunization schedule?

A: The standard schedule includes one primary dose followed by one booster dose six months after the first injection. The booster shot strengthens long-term antibody response. Health practitioners should follow local immunization guidelines when applying the schedule for national or institutional vaccination programs.

Q: Is this vaccine suitable for bulk public health procurement?

A: Yes. The production line has GMP certification and scalable manufacturing capacity. We support bulk orders for national immunization agencies, international health organizations and vaccine distributors. Our team can supply required certification documents for tender submission and import registration review.

Q: What cold chain conditions are required for storage and transport?

A: The vaccine must be stored and transported within the recommended refrigerated temperature range. Freezing should be avoided, as freezing may damage the antigen structure and compromise product quality. Temperature monitoring is required across the whole logistics chain.

Q: What is the difference between human diploid cell vaccine and vaccines using other cell substrates?

A: Human diploid cell substrate avoids risks of exogenous viral contamination and tumorigenicity linked to animal cell materials. This cell system has long-term safety validation history and delivers a purer final vaccine product, which is widely recognized by global vaccine regulators for human immunization use.

Q: Can I get sample and test documentation support before placing bulk orders?

A: Sample availability and supporting test documents can be discussed with our international sales team. Due to biological product control rules, sample quantities are limited. Batch release reports and quality documents can be provided for the corresponding commercial batches once procurement terms are confirmed.

Structure of hepatitis A virus