Advaxia

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.