ABOUT US
ABOUT US
About
About
Scientific Leadership
Scientific Leadership
Industry Standards
Industry Standards
Mission
Mission
Facility
Facility
cGMP Campaigns
cGMP Campaigns
ABOUT US
We are a leading-edge contract development & manufacturing organization.
Advaxia is trusted by transformative pharmaceutical companies throughout the world. We have developed and manufactured an Ebola Virus Vaccine for GlaxoSmithKline, served as a testing site for AstraZeneca’s COVID-19 vaccine, and produced COVID-19 clinical batches — and we continue to break new ground in the creation of adenovirus-based vaccines.
Altogether, we have helped prepare regulatory dossiers for more than 50 pharmaceutical products, spanning a variety of regulatory authorities and government entities throughout the United States, Europe, ASIA and Canada.
We operate in full compliance with the guidelines of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Italian National Regulatory Authority (AIFA). We are authorized for manufacturing and testing of investigational medicinal products and testing of human medicinal products (commercial AZD1222 vaccine). We are also ISO 14.001 and ISO 45.001 certified.
LEADERSHIP TEAM
Dr. Stefania Di Marco, Ph.D.
Qualified Person and Scientific Director
Currently, Scientific Director and Qualified Person of the biotech Advaxia S.r.l. (part of IRBM), Pomezia-Roma.
- 12-year GMP experience in production, testing and release of investigational adenovirus-based vaccines for infectious diseases (HCV, malaria, RSV, HIV, Ebola, leishmaniasis, rabies, HBV, RVF and SARS-CoV-2) and investigational gene therapy products for cancer.
- Author of 58 peer-reviewed publications and inventor of four patents.
- 12-year experience in the evaluation and review/monitoring of EU-funded research programmes: FP7, H2020 and HORIZON proposals; Eureka-Eurostars proposals.
- 18-year research experience as Senior Researcher/Group Leader in preclinical drug discovery and development, employing molecular biology, biochemistry and X-ray crystallography for functional studies and structure-based drug design (six years at Novartis and twelve years at Merck). Main research subjects have been medically relevant protein targets in several therapeutic areas, like Infectious Diseases, Anti-Thrombotics, Cardiovascular and Oncology.
- She graduated in Biological Sciences from the University of Rome La Sapienza and obtained a PhD in Cellular and Molecular Biology from the University of Rome Tor Vergata.
We set industry standards in cGMP innovation and expertise.
- Construction, rescue and production of research-grade recombinant viral vectors
- Preclinical process development and scale-up
- Analytical development and validation
- GMP manufacturing
- GMP Quality Control
- QP release
- Quality Assurance and Regulatory Affairs support
Our mission is to deliver tomorrow’s medicines — today.
Vaccine breakthroughs are our passion. A healthier world is our goal. We help our clients build that world by optimizing the quality and cost-effectiveness of every clinical lot we produce. From analytical method development to process validation, to in-process assay release setup and qualification and cell banking, we relentlessly pursue scientific excellence in adenoviral vaccine manufacturing, so you can run world-changing clinical trials.
We make our facility openly available to client audits, as well as to examinations by regulatory bodies, including local authorities — and our unique approach to flawless operation ensures that we pass every inspection, by incorporating all of the following:
- Compliance with regulatory and customer requirements
- Risk management principles
- Continuous improvement through the monitoring of key performance indicators (KPIs) and their regular review by the management team
But above all, our industry-leading excellence rests on the shoulders of our team, whom we hold to elite cGMP standards encompassing product quality, purity, process efficiency and robustness. We recognize that patient safety comes first — and that requires state-of-the-art equipment, as well as a relentless striving for perfection across all areas of manufacturing and development. Our team members are equipped with decades of combined experience in academia and the pharmaceutical industry, and their collaboration continues to accelerate breakthrough achievements for our clients every day.
Our facility and team provide comprehensive support throughout production and development.
At our state-of-the-art facility on the IRBM campus outside Rome, we have set an unparalleled track record in clinical lot success: a full 100 percent of the batches we manufacture have been approved and released.Â
Covering an area of 750 square meters, our cGMP manufacturing facility is divided into the following sections:
- 6 C-grade (ISO 8) classified independent production rooms (1 Cell culture room, 2 Virus production rooms, 1 Virus purification room, 1 Media preparation room, 1 dispensing room)
- 2 B-grade (ISO 7) classified clean rooms dedicated to fill and finish
Our integrated controlled temperature unit storage system is monitored around the clock, and includes an ultra-low freezer system, vapor phase LN2 tanks, and multiple layers of emergency backup devices. We also maintain a manufacturing-dedicated warehouse area, and control access through a secure building management system (BMS) checkpoint.
These facilities enable our expert staff to deliver a full array of production services, including:
- cGMP Master and Working Cell Bank Production (MCB, WCB)
- cGMP Master and Working Virus Bank Production (MVB, WVB)
- DS and DP Production
- DP Fill and Finish
- Process intermediate, and final product storage
- Quality control/quality assurance services
- Support dossier filing with all necessary regulatory authorities
Our process development team paves the way for successful GMP campaigns.
In addition to our primary GMP facility, we also maintain a separate 200-square-meter R&D/process development area, equipped with a full set of tools for executing development and engineering work packages, including the following components:
- Research cell banks capable of handling up to 450 vials (1 batch/month)
- Virus banks capable of handling up to 550 vials (1 batch/45 days)
- Pre-GMP viral seed stock generation and characterization
- Toxicology lot production and filling
- Upstream and downstream small-scale process simulation
- Process development and engineering runs