Oeiras

Advanced Bio in Oeiras, Portugal 

Advanced Bio in Oeiras is a multiproduct biotherapeutic manufacturing facility. The site is located in Oeiras, Portugal, approximately 20 km away from Lisbon Airport.  

The Oeiras facility offers ​a ​21,500 ft2 (2,000 m2) facility with 5 cGMP Suites to support: 

• Cell and Virus banking 
• Virus, Virus-like Particles and Viral-vectors 
• DNA and RNA products 
• Polysaccharides  
• Live Biotherapeutic Products 
• Recombinant Proteins 
• Manual Sterile Fill-Finish 

​​The​​ ​Oeiras ​facility ​was built to offer a unique combination of problem-solving attitude and flexibility while ensuring strict GMP compliance. ​Advanced Bio establishes the ​best-tailored​ solutions for each product and can manufacture a wide range of biopharmaceuticals across all stages of clinical development.

Throughout a close collaboration with iBET, ​Advanced Bio ​can offer its customers ​process development services, process characterization and final quality control solutions all within the same location. iBET is the largest private ​not-for-profit​​ research institute in Portugal with more than 30 years ​of ​expertise in developing manufacturing solutions for different biologic entities. 

The Oeiras site has a robust Quality System designed to ensure strong contamination control strategies using single-use technologies. The site was approved in 2023 by FDA for the manufacturing of the first commercial oral microbiome product – ​​VOWST. 

Advanced Bio in Oeiras has been approved by the local Portuguese Regulatory Authority (Infarmed) since 2009 and holds a Certificate of GMP Compliance of a Manufacturer (certificate F053/S1/SA/001/2022) for the production of biological API/Drug Substance (Online EudraGMP, Ref key: 155486).  ​

The Oeiras site​​ also has a Manufacturer Authorization (MA - F053/001/2022) for Human Investigational Medicinal Products (IMPs)/Drug Product for immunological products, cellular and gene therapies and for biotechnology products (e.g. originated from ​viruses​​​, bacteria or cells)​,​ with the correspondent GMP certificate (certificate F053/S1/ME/001/2022) (Online EudraGMP, Ref key: 156028).