Biotechnology products for use in human clinical trials must be manufactured in compliance with the current good manufacturing practice (cGMP) as defined by the regulatory frameworks. These practices are necessary to assure that such products meet the safety requirements for their use in humans.
The GMP facility, directed by Prof. Riccardo Cortese, complies with the regulatory guidelines of FDA and EMEA, with the objective to maximize quality and cost effectiveness. This multi-product facility is dedicated to the production of clinical lots of Biologics, including viral vectors, recombinant proteins, antibodies for vaccine and gene therapy application as well as cell banks with an expert technical staff, which performs these procedures on a routine basis.
Advent is producing investigational medicinal products, including the Okairos Ebola vaccine.
The company collaborates with industry and public institutions such as the NIH and the University of New York.
The facility consists of 5 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. The access to the classified grade C corridor is possible through an air lock vestibule which serves as gowning room. In addition, to prevent cross-contamination, the access to each single laboratory is through an additional interlocked double door vestibule that allows the personnel to follow the most appropriate dress code for the production. The production laboratories are equipped with laminar flow safety cabinets with 100% exhaust to minimize cross-contamination and with disposable bioreactors.
Adenovirus purification can be performed by CsCl gradient ultracentrifugation or by AEX chromatography. A state of the art QC lab is located outside the facility. The lab is equipped to run the product specific QC assay for adenoviral vectors including potency/infectivity assay, titration of physical particles, characterization of vector structure, stability studies as well as appropriate in process controls. 4 tissue culture rooms are dedicated to the production of vectors for preclinical study and to process development studies. FPLC and HPLC systems dedicated to the vector purification allow an efficient tech transfer for downstream process as well as purification scale up studies.
|Specific Functions of the GMP Pilot Plant|
|Construction, Rescue and Production of Research Grade Recombinant Adenoviral Vectors|
|Preclinical Process Development and Scale-up|
|Analytical Development and Validation|
|GMP Manufacturing for Gene Products|
|GMP Quality Control|
|Quality Assurance and Regulatory Affairs|