Piattaforma di Cell Factory

Description

The Cell Factory Group brings together Production, Quality Assurance and Quality Control staff together with a Qualify Person (responsible for the release of Advanced Medicinal Therapy Products for clinical use). The team provides the expertise needed to define manufacturing processes and quality control tests that comply with Good Manufacturing Practice (GMP).

The new Cell Factory, located within the IRCSS ISMETT hospital facility, will enable the production of advanced therapies developed by the institution’s researchers, both for clinical trials and for patient-specific hospital use.

In addition, specific Technology Transfer agreements with the University of Pittsburgh and with other Cell Factories or companies in Italy and Europe will make it possible to manufacture externally developed products for clinical use at the hospital or in other healthcare facilities.

Expertise

• Establishment of a GMP-compliant Quality Assurance System;
• Development of manufacturing protocols;
• Design of Quality Control Methods;
• Validation of environments, equipment and products;
• GMP training.

Facilities & Equipment

The New Cell Factory, commissioned in December 2021, ensures flexibility across different types of production and an optimal environmental functionality. Based on specific User Requirements, layouts for the production and quality control areas were developed (and approved by AIFA during a Scientific Advice meeting) for different types of advanced therapies: gene therapy, somatic cell therapy, tissue engineering and combined advanced therapy medicinal products.

The Facility includes four Class B laboratories, one of which has higher containment and is equipped with a pass-through autoclave for waste treatment. The remaining three Class B laboratories can operate completely independently, allowing the simultaneous preparation of three different products, or can be connected in pairs so that an intermediate product prepared in one laboratory can be transferred via pass-box to the adjacent laboratory for further processing. A Class C room has also been created for the use of closed cell preparation systems.

Technical rooms that house the equipment motors allow maintenance to be carried out without entering the production areas. Large Quality Control laboratories are fully equipped to perform all required tests on row material, intermediated and final product release, as well as to receive and store reagents, materials and finished products.

Both the Production area and the Quality Control laboratories are equipped with a monitoring system that enables remote control of critical parameters.