Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center
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)-b...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-06-01
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| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/10/7/999 |
| _version_ | 1827626386956746752 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Elena Pancisi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T12:53:58Z |
| format | Article |
| id | doaj.art-81747b5ebaba429caba0e93b295c5085 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T12:53:58Z |
| publishDate | 2022-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-81747b5ebaba429caba0e93b295c50852023-11-30T22:02:18ZengMDPI AGVaccines2076-393X2022-06-0110799910.3390/vaccines10070999Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer CenterElena Pancisi0Anna Maria Granato1Emanuela Scarpi2Laura Ridolfi3Silvia Carloni4Cinzia Moretti5Massimo Guidoboni6Francesco De Rosa7Sara Pignatta8Claudia Piccinini9Valentina Soldati10Luana Calabrò11Massimo Framarini12Monica Stefanelli13Jenny Bulgarelli14Marcella Tazzari15Francesca Fanini16Massimiliano Petrini17Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyBiostatistics and Clinical Trials Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyImmuno-Hematology and Transfusion Medicine, AUSL Romagna, 47121 Forlì, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOncologic and General Surgery, AUSL Romagna, 47121 Forlì, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyOsteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, 47014 Meldola, ItalyAdvanced 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.https://www.mdpi.com/2076-393X/10/7/999immunotherapydendritic cell vaccinequality controlATMPstability |
| spellingShingle | 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 Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center Vaccines immunotherapy dendritic cell vaccine quality control ATMP stability |
| title | Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center |
| title_full | Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center |
| title_fullStr | Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center |
| title_full_unstemmed | Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center |
| title_short | Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center |
| title_sort | stability program in dendritic cell vaccines a real world experience in the immuno gene therapy factory of romagna cancer center |
| topic | immunotherapy dendritic cell vaccine quality control ATMP stability |
| url | https://www.mdpi.com/2076-393X/10/7/999 |
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