mAbs医薬品の製品、特に高濃度製剤は、薬剤と容器の相互作用や投与デバイスの機能性の影響を受けやすくなります。
薬物の長期にわたる安定性、効能性、および安全性
開発の初期段階から
治療遵守を向上させる信頼性の高い投与システム
より高い濃度と注入量
Stevanato Groupは、医薬品バリューチェーン全体をカバーする包括的なソリューションでバイオ医薬品の製造プロセスに貢献できます。当社は市場における独自の地位を確立しており、一次包装、デバイス、機械、および分析サービスの総合プロバイダーとなることができます。
Trend and insights
The biologics market is growing enormously. Due to the low stability of biologics, 24% of biologic drugs newly approved by the FDA between 2017 and 2021 are lyophilized.
Challenge
EZ-fill® nested vials are in a suspension frame “nest”, contrary to conventional loading where the vials are in direct contact with the freeze-dryer shelf. The suspended configuration avoids glass-to-glass contact during the filling phase and reduces mechanical stress which could lead to vial breakage but it may raise doubts about the heat transfer mechanism from the shelf to the vials.
Solution
Stevanato Group, in collaboration with the Politecnico di Torino University (POLITO), has conducted a series of tests on freeze-drying pharmaceuticals in nested vials demonstrating that EZ-fill® Vials are high-value solutions for lyo products.
The overall study results, performed on a 3ml ISO vial, not only confirmed the usability of nested vials for lyophilization but, above all, demonstrated their potential as a high-value solution for freeze-dried pharmaceutical products.
Objective
verify thermal properties of the nest during and after freeze-drying process, focusing on the impact on time of freeze-drying cycle and on intra-batch variability
Results
EZ-Fill® Nest & Tub configuration, in comparison to Bulk configuration:
Conclusions