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, comply 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.
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 Ad vectors
- Production of clinical grade recombinant Ad vectors under cGMP conditions
- Perform quality control testing.