バイオ医薬品 - Stevanato Group
複雑で敏感で安定化が難しい薬剤を革新的な投与ソリューションで提供
Home - Stevanato Group > Markets - Stevanato Group > バイオ医薬品 - Stevanato Group
page-wrapper

敏感な薬剤の安定性の確保

バイオ医薬品市場は、2027年までに2桁 (+15%) の年間複合成長率 (CAGR) を達成すると予測されています。[1]Stevanato Groupは、最先端の分析サービス、信頼性の高いテクノロジー、そして製造機器を組み合わせた、新世代の医薬品に適した新しいガラス製医薬品密封ソリューションと医薬品投与デバイスを提供しています

[1] - Source: IQVIA and Stevanato Group internal analysis

主な課題

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。

主な課題
05 Safety

薬物の長期にわたる安定性、効能性、および安全性

155 R&D

開発の初期段階から

92B Filled Syringe+Add Ons

治療遵守を向上させる信頼性の高い投与システム

348_Water_diluent

より高い濃度と注入量

biologics wide
biologics wide

統合されたサービスを通じてバイオ医薬品の最適なパートナーとなるStevanato Group

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

infographics integrated offering mAbs
infographics integrated offering mAbs

当社のソリューション

EZ-fill®キット

臨床段階ですか?EZ-fill®キットがどのように役立つかをご覧ください。

データと結果

Proven Lyophilization of RTU Nested Vials

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.

Comparison of vials in bulk and EZ-fill® configuration throughout a lyophilization process

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:

  • Simplify lyophilization industrial cycle scale-up with no impact on cycle time
  • Reduce intra-batch variability, improving the overall quality of the lyophilized cake

Conclusions

  • The temperature difference between the vials and the NEST is very limited = limited impediment of the nest to the heat transfer.
  • Chamber pressure has less impact on the Kv (heat transfer coefficient) in vials in NEST, compared to the SHELF configuration

Interval plot of Fmax

Interval plot of Pmax

Read More

Alba® platform ensures stability for sensitive drug

Line plot of break loose force Alba Syringe

Line plot of extrusion force Alba Syringe

Average particles Alba Syringe

Read More

Article

Biologic integrity: measuring and managing the hidden leachables risk from PFS adhesive

White Paper

Alba® platform ensures stability for sensitive drugs