---
name: Advaxia
slug: advaxia
site: cdmo
website_domain: advaxia.com
summary: cGMP CDMO specializing in adenovirus vaccine development and manufacturing with a 100% batch approval rate and 10+ years of biologics expertise, serving major pharmaceutical and biotech clients. Headquartered in Rome, Italy.
tagline: Adenovirus vaccine CDMO with 100% batch approval rate and 10+ years of biologics expertise.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: IT
tier2_domain_verified: false
updated_at: 2026-09-27T07:01:31.033Z
services_count: 7
modalities_count: 2
indications_count: 1
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Advaxia

Adenovirus vaccine CDMO with 100% batch approval rate and 10+ years of biologics expertise.

Listed on cdmo.directory.

## Summary

cGMP CDMO specializing in adenovirus vaccine development and manufacturing with a 100% batch approval rate and 10+ years of biologics expertise, serving major pharmaceutical and biotech clients. Headquartered in Rome, Italy.

## At a glance

- HQ country: IT

## Services

- Cell-Line Development
- Process Development
- CMC Analytical Development
- Quality Control Testing
- CMC Regulatory Submission Support
- Vaccine Manufacturing
- Viral Vector Manufacturing

## Modalities

- Vaccine
- Gene Therapy

## Indications

- Infectious Disease

## Locations

- Headquarters & Manufacturing Facility, Rome, Lazio, Italy

## Certifications

- EMA; Identifier: EMA compliant; Source: https://advaxia.com/
- FDA; Identifier: FDA compliant; Source: https://advaxia.com/
- AIFA; Identifier: AIFA compliant; Source: https://advaxia.com/
- ISO; Identifier: ISO 14.001; Source: https://advaxia.com/
- ISO; Identifier: ISO 45.001; Source: https://advaxia.com/

## Long description

Advaxia is a cGMP contract development and manufacturing organization (CDMO) focused on adenovirus-based vaccines and biologics. The company offers a fully integrated service portfolio spanning development, manufacturing of preclinical and clinical supply, and regulatory support.

## Capabilities

- **Expression Systems:** Generation of high-quality GMP-enabling materials including cell lines and virus seed stocks
- **Process Development:** Translation of research data into reproducible production workflows optimized for clinical success
- **Analytical Development:** Method development, phase-appropriate qualification, and validation using industry-leading equipment and expertise
- **cGMP Manufacturing:** Adenoviral production platforms aligned with current industry best practices and regulatory guidelines
- **Quality Control & Assurance:** Dedicated QC/QA teams with detailed protocols and continuous improvement practices
- **Regulatory Support:** CMC support throughout clinical regulatory processes, from drafting to clinical filing

## Track Record

Advaxia operates a state-of-the-art facility on the IRBM campus outside Rome with an unparalleled 100% batch approval rate. The company has developed and manufactured Ebola Virus Vaccine for GlaxoSmithKline, served as a testing site for AstraZeneca's COVID-19 vaccine, and manufactured COVID-19 vaccine clinical batches.

## Compliance

Fully EMA, FDA, and AIFA compliant; ISO 14.001 and ISO 45.001 certified.

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_Profile last updated: 2026-09-27T07:01:31.033Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.