Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center
Elena Pancisi,
Anna Maria Granato,
Emanuela Scarpi,
Laura Ridolfi,
Silvia Carloni,
Cinzia Moretti,
Massimo Guidoboni,
Francesco De Rosa,
Sara Pignatta,
Claudia Piccinini,
Valentina Soldati,
Luana Calabrò,
Massimo Framarini,
Monica Stefanelli,
Jenny Bulgarelli,
Marcella Tazzari,
Francesca Fanini,
Massimiliano Petrini
Affiliations
Elena Pancisi
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Anna Maria Granato
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Emanuela Scarpi
Biostatistics and Clinical Trials Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Laura Ridolfi
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Silvia Carloni
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Cinzia Moretti
Immuno-Hematology and Transfusion Medicine, AUSL Romagna, 47121 Forlì, Italy
Massimo Guidoboni
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Francesco De Rosa
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Sara Pignatta
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Claudia Piccinini
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Valentina Soldati
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Luana Calabrò
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Massimo Framarini
Oncologic and General Surgery, AUSL Romagna, 47121 Forlì, Italy
Monica Stefanelli
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Jenny Bulgarelli
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Marcella Tazzari
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Francesca Fanini
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Massimiliano Petrini
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, Italy
Advanced therapy medical products (ATMPs) are rapidly growing as innovative medicines for the treatment of several diseases. Hence, the role of quality analytical tests to ensure consistent product safety and quality has become highly relevant. Several clinical trials involving dendritic cell (DC)-based vaccines for cancer treatment are ongoing at our institute. The DC-based vaccine is prepared via CD14+ monocyte differentiation. A fresh dose of 10 million DCs is administered to the patient, while the remaining DCs are aliquoted, frozen, and stored in nitrogen vapor for subsequent treatment doses. To evaluate the maintenance of quality parameters and to establish a shelf life of frozen vaccine aliquots, a stability program was developed. Several parameters of the DC final product at 0, 6, 12, 18, and 24 months were evaluated. Our results reveal that after 24 months of storage in nitrogen vapor, the cell viability is in a range between 82% and 99%, the expression of maturation markers remains inside the criteria for batch release, the sterility tests are compliant, and the cell costimulatory capacity unchanged. Thus, the data collected demonstrate that freezing and thawing do not perturb the DC vaccine product maintaining over time its functional and quality characteristics.
