生物工艺的未来

生物工艺的未来

基于单克隆抗体的治疗

单克隆抗体疗法在医药领域发挥着日益重要的作用，为各种疾病提供了靶向和精准的治疗方案。为确保这些疗法的成功实施，构建坚实的基础设施与资源体系不可或缺。 我们将带您深入了解那些能够加速单克隆抗体研发进程的创新解决方案，并探索推动该领域持续进步与发展的前沿分析技术、过程自动化工具及质量控制解决方案。

无论您是科研先锋、制药行业的精英，还是对单克隆抗体开发的复杂性充满好奇的探索者，该网页内容都是您的首选资源。让我们深入了解单克隆抗体的世界，共同探索为创新并高效的治疗方法铺设坚实基石的解决方案！

 

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企业使命：推动生物工艺的未来发展

Monoclonal Antibody Development Workflow

单克隆抗体开发涉及几大关键阶段，每个阶段在实现潜在疗法方面均发挥着至关重要的作用。从筛选和验证目标基因开始，研究人员需识别和筛选与目标疾病或病症相关的靶点基因。此步骤为后续开发阶段奠定了坚实基础。

下一阶段涉及细胞系开发和克隆筛选。研究人员对宿主细胞进行工程改造，以产生所需的单克隆抗体。该过程需优化细胞培养条件，筛选高产量细胞系，并筛选克隆以确定具备理想特性的克隆。我们致力于在每一关键环节，为您提供卓越且高效的技术支撑。下载信息图，了解更多信息。


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Whitepaper

Automation in Therapeutic Antibody Development

Automation offers a promising solution to challenges during antibodies development by:

  • Accelerating decision-making
  • Enhancing quality control
  • Streamlining development processes

This whitepaper explores the latest progress in mAb development and highlights how automation can expedite the journey from bench to bedside.

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Whitepaper

Recent Trends in Therapeutic Antibodies Development

It's been nearly 50 years since Georges J.F. Köhler and César Milstein pioneered the hybridoma method for producing monoclonal antibodies (mAbs). Since then, there has been a rapid expansion in the field of mAbs and antibody–drug conjugates (ADCs) in development. In this article, we outline trends and challenges in therapeutic antibody development and explore the innovations reducing development timelines and costs.

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生物工艺的未来

工艺开发

细胞系开发

细胞外囊泡

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The Vi-CELL BLU cell viability analyzer: Cell counter performance comparison for CHO and HEK cells

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Variability Analysis of the Vi-CELL BLU Cell Viability Analyzer against 3 Automated Cell Counting Devices and the Manual Method

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Integration of the Vi-CELL BLU Cell Viability Analyzer into the Sartorius Ambr® 250 High Throughput for automated determination of cell concentration and viability

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Cluster Count Analysis and Sample Preparation Considerations for the Vi-CELL BLU Cell Viability Analyzer

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Automating the Valita Titer IgG Quantification Assay on a Biomek i-Series Liquid Handling System

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Introducing the Cydem VT Automated Cell Culture System

 

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参考文献

The Nobel Prize. The Nobel Prize in Physiology or Medicine 2018 – press release. (2018). https://www.nobelprize.org/prizes/medicine/2018/press-release/. 2. The Nobel Prize. The Nobel Prize in Physiology or Medicine 1984 – press release. (1984).
The Nobel Prize. The Nobel Prize in Physiology or Medicine 1984 – press release. (1984). https://www.nobelprize.org/prizes/medicine/1984/press-release/.
Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: Understanding time lags in translational research. J R Soc Med. 2011;104(12):510-520. doi:10.1258/JRSM.2011.110180
PhRMA. (2016). Modernizing Drug Discovery, Development and Approval. Accessed February 9, 2024. https://phrma.org/en/resource-center/Topics/Research-and-Development/Modernizing-Drug-Discovery-Development-and-Approval.
Alhazmi HA, Albratty M. Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies. J Pharm. 2023;16(2). doi:10.3390/PH16020291.
European Medicines Agency. (2023). ICH guideline Q14 on analytical procedure development. Accessed February 12, 2024. https://www.ema.europa.eu/en/ich-q14-analytical-procedure-development-scientific-guideline.
World Health Organization. (2022). Guidelines for the production and quality control of monoclonal antibodies and related products intended for medicinal use. Accessed February 12, 2024. https://www.who.int/publications/m/item/guideline-for-the-safe-production-and-quality-control-of-monoclonal-antibodies.
US Food & Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) Regulations. Accessed February 12, 2024. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations.
European Medicines Agency. Good manufacturing practice. (2023). Accessed February 12, 2024. https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice.
Sifniotis V, Cruz E, Eroglu B, Kayser V. Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation. Antibodies 2019, Vol 8, Page 36. 2019;8(2):36. doi:10.3390/ANTIB8020036.
Wolf B, Piksa M, Beley I, et al. Therapeutic antibody glycosylation impacts antigen recognition and immunogenicity. Immunology. 2022;166(3):380-407. doi:10.1111/IMM.13481.