Pancisi Elena, Granato Anna Maria, Scarpi Emanuela, Ridolfi Laura, Carloni Silvia, Moretti Cinzia, Guidoboni Massimo, De Rosa Francesco, Pignatta Sara, Piccinini Claudia, Soldati Valentina, Calabrò Luana, Framarini Massimo, Stefanelli Monica, Bulgarelli Jenny, Tazzari Marcella, Fanini Francesca, Petrini Massimiliano
Osteoncology and Rare Tumors Center, Immunotherapy, Cell Therapy and Biobank, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014 Meldola, Italy.
Biostatistics and Clinical Trials Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014 Meldola, Italy.
Vaccines (Basel). 2022 Jun 23;10(7):999. doi: 10.3390/vaccines10070999.
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.
先进治疗医药产品（ATMPs）作为治疗多种疾病的创新药物正在迅速发展。因此，质量分析测试对于确保产品安全和质量一致性的作用变得至关重要。我们研究所正在进行几项涉及基于树突状细胞（DC）的癌症治疗疫苗的临床试验。基于DC的疫苗是通过CD14+单核细胞分化制备的。给患者注射一剂1000万个新鲜的DC，而其余的DC则进行分装、冷冻，并储存在氮气中以备后续治疗剂量使用。为了评估质量参数的维持情况并确定冷冻疫苗分装的保质期，制定了一个稳定性计划。对DC最终产品在0、6、12、18和24个月时的几个参数进行了评估。我们的结果表明，在氮气中储存24个月后，细胞活力在82%至99%之间，成熟标志物的表达仍在批放行标准范围内，无菌测试合格，细胞共刺激能力未变。因此，收集到的数据表明，冻融不会干扰DC疫苗产品，其功能和质量特性随时间保持稳定。
