cGMP CONTRACT DEVELOPMENT &
MANUFACTURING ORGANIZATION
cGMP CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATION
Uniquely equipped CDMO partner with an unparalleled track record.
Fully integrated service portfolio for adenovirus vaccines — from development, to manufacturing of pre-clinical and clinical supply.
- 100% batch approval rate
- 10+ Years of biologics expertise
- Fully EMA, FDA & AIFA compliant
- ISO 14.001 & ISO 45.001 certified
WE SPECIALIZE IN:
Expression Systems
We possess extensive experience in generating high quality/GMP enabling materials such as cell lines and virus seed stocks.
Process Development
We blaze new trails in biologics development & manufacturing, by translating leading-edge research data into hands-on, reproducible production know-how that will maximize your probability of success in the clinic.
Analytical Development
Our laboratory possesses industry-leading equipment, software and scientists who specialize in method development, phase appropriate qualification and validation.
cGMP Manufacturing
We have perfected a wide array of adenoviral production platforms, in alignment with the latest industry best practices and regulatory guidelines.
Quality Control
Our dedicated QC team relentlessly seeks out opportunities to improve our capabilities, equipment, staff training and operational standards.
Quality Assurance
We have developed detailed protocols and practices to improve and streamline the QA process across all our project workflows.
Regulatory Support
We provide CMC support throughout every stage of the clinical regulatory process, from drafting to clinical filing, to help maximize the probability of success for approval.
ABOUT US
Advaxia is trusted by transformative pharmaceutical and biotech companies throughout the world. We have developed and manufactured Ebola Virus Vaccine for GlaxoSmithKline, served as a testing site for AstraZeneca’s COVID-19 vaccine, manufactured COVID-19 vaccine clinical batches, and we continue to break new ground in the creation of adenovirus-based vaccines.
100% Successful
Track Record
At our state-of-the-art facility on the IRBM campus outside Rome, we have set an unparalleled track record in clinical lot success: 100 percent of the batches we manufacture have been approved and released.
CAREERS
We’re always on the lookout for top performers and leading innovators in the areas of vaccine research, development and biologics manufacturing.
NEWS &
EVENTS
Advaxia’s QP and Scientific Director, Dr. Stefania Di Marco to present at the World Vaccine Congress in Barcelona. Title of Dr. Di Marco’s talk: Viral Vaccine Manufacture:
- Merits and potential pitfalls of using the adenovirus in comparison to other systems
- Applications of adenoviral-mediated vaccines with an emphasis on the SARS-CoV-2 vaccine AZD1222