ADVENT is a cGMP Contract Manufacturing Organization (CMO) complying with the regulatory guidelines of both FDA and EMEA, with the objective to maximize quality and cost effectiveness of clinical lot production. This multi-product facility is dedicated to biologics, including viral vectors, recombinant proteins, antibodies for vaccine and gene therapy applications, as well as cell banks.
ADVENT’s experienced technical stuff is currently working on the production of investigational medicinal products, including the Chad-Zaire3 Ebola vaccine. The company collaborates with private and public institutions such as the NIH and New York University.
The facility consists of five independent production rooms, a media prep room, a storage area, a purification room and a fill/finish suite. All laboratories are classified grade C areas with the exception of the grade B fill/finish suite. Adenovirus purification can be performed by CsCI gradient ultracentrifugation or by AEX chromatography. A state-of-the-art QC laboratory is located outside the facility and used to run specific QC assays for adenoviral vectors. FPLC and HPLC systems dedicated to vector purification allow an efficient process for downstream usage, as well as purification scale-up studies.