Biological Investigational Medicinal Products
ADVENT is a cGMP Contract Manufacturing Organization (CMO), located in Pomezia within the IRBM campus, and complying with the regulatory guidelines of both FDA and EMA. The GMP facility has been granted the authorization to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA).
ADVENT’s multi-product facility is dedicated to the production of biologic clinical lots. The site is currently focused on adenovirus-based viral vectors, for vaccine and gene therapy applications.
ADVENT’s mission is to maximize quality and cost effectiveness of clinical lot production on behalf of its customers. This is achieved by the outstanding scientific support the team can provide in such areas as analytical method development, process development/validation, in-process assay release setup and qualification and cell banking.
The facility consists of five independent production rooms, a media prep room, a storage area, a purification room and a fill/finish suite. It is designed to provide maximum flexibility and continuity in the manufacturing process. All laboratories are state-of-the-art classified grade C areas with the exception of the grade B fill/finish suite.
Adeno Viral Vector Production
FPLC and HPLC systems dedicated to vector purification allow an efficient process for downstream usage, as well as purification scale-up studies. 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 the vectors.
ADVENT can provide a series of services as an integrated package or as a stand-alone service, depending on the needs of its customers. It can provide support for the following processes:
- Construction, rescue and production of research-grade recombinant viral vectors
- Preclinical process development and scale-up
- Analytical development and validation
- GMP manufacturing for gene products
- GMP Quality Control
- QP release
- Quality Assurance and Regulatory Affairs support
ADVENT has an unprecedented track record in clinical lot release with all batches manufactured since its inception being successfully released.