Good Manufacturing Practice (GMP)
Our strict quality assurance programme ensures that our medicinal products are consistently produced and controlled to the highest quality standards. We are a GMP-accredited manufacturing facility and meet the most stringent criteria from the US government’s Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to produce material to be used in human clinical studies.
We have recently established a joint venture named ADVENT S.r.l. with the IRBM Science Park to produce investigational medicinal products. This Good Manufacturing Practice (GMP) facility has been designed to maximize quality and cost effectiveness.
Our production and purification area consists of five independent production rooms, a media preparation room, storage area, purification room and a fill and finish suite.
Our facility’s specialisation is the GMP production of novel vaccines and gene therapy products using adenoviral vectors. Adenovirus purification can be performed by cesium chloride gradient ultracentrifugation or by anion-exchange chromatography.
State-of-the-art laboratories
We also have fully-equipped, state-of-the-art laboratories, located outside the GMP production/purification area, housing the following features:
• GMP quality control (QC). The laboratory is equipped to run the product-specific QC assays. In particular, for adenoviral vectors they include: potency/infectivity assay, titration of physical particles, characterisation of vector structure, stability studies as well as appropriate in-process controls.
• Preclinical and process development. Four 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 technology transfer for downstream process as well as purification scale-up studies.
Hire our facilities
We can provide a series of services as an integrated package or as a stand-alone service, including the following processes:
• 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
• QP Release
• Quality assurance and regulatory affairs
Contact us for more information, to discuss your project or to request a quote.