第一至第二階段
一旦研究性新藥 (IND) 的申請被接受，就可以開始第一階段臨床試驗。
現在是開發、標準化和擴展藥物製造能力的時候，也是確保適當的分析和品質控制流程標準化的時候
一旦候選藥物的安全性得到確立，II 期試驗將評估其療效。此階段的成功可引起合作夥伴和投資人的興趣。在這個階段，重點在於擴大規模和進一步優化製程，並確保內毒素含量和無菌性符合標準。
特色類別
生物技術資源
- Biopharmaceutical Application Guide
Navigate the biopharmaceutical landscape with our application guide, providing resources and solutions for mAb, ADC, and mRNA processes.
- A Molecule’s Journey: Breaking Down Roadblocks to Clinical Success
A guidebook for biopharma executives navigating the complexities of clinical development. Learn how to successfully bring a molecule from the lab to the clinic.
- Quality and Regulatory Trends
Explore how we ensure high-quality products and services with a focus on compliance, risk management, and a strong code of conduct.
- Using a 3L Disposable Bioreactor to Increase Your Throughput Development Capacity
This webinar showcases the efficiency and economy of single-use bioreactors. Discover how using a 3L single-use bioreactor can enhance your throughput development capacity in therapeutic protein process development.
- Biosimilar Upstream Process Development – The Challenges and Promises
Explore the challenges and promises of biosimilar upstream process development. Learn how process changes impact product quality and achieve consistency in manufacturing.
- Mobius Single-Use Bioreactors Scalability: Bench to Clinical Scale
Discover how Mobius® Single-use Bioreactors enhance throughput development capacity, offering scalable solutions from bench to clinical scale.
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