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到位、能力標準化的時候
一旦候選藥物的安全性得到確定，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。
開發和實施臨床規模製程既耗時又複雜，需要規範、採購和整合許多元件。使用 生物製藥應用指南 ：
- 疫苗（包括 mRNA）
- 單克隆抗體 (mAbs)
- 抗體藥物結合物 (ADC)
- 微生物
- 質粒 DNA (pDNA)
- 細胞和基因治療 (CGT)
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.
取得正確的資源可協助您專注於最有潛力幫助有需要的病患的發現和臨床候選藥物。請選擇您所處的開發流程階段，以瞭解更多資訊，或依照產品和服務連結，取得在創業初期提供即插即用機會的資源。
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