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主页应用制药和生物制药生产基因治疗制剂生产

基因治疗制剂生产

新的基因治疗制剂给苦于治疗手段匮乏的患者带来了希望，正推动着市场对快速创新的需求，催生了数以百计的全球基因治疗制剂开发项目。但打造创新的基因治疗制剂需要高水平的病毒载体生产和检验专业知识。基因治疗制剂生产还面临着诸多挑战，包括难以缩短治疗应用周期、缺乏成熟工艺模板、监管指南不断变化等。

基因治疗制剂生产商要杀出重围，必须突破工艺开发、扩大化、生产及监管合规等重重障碍——所有这一切都压缩在3-5年内完成，不到传统药物开发的一半。

成功的生产商还必须能敏捷地清除法规、安全性和工艺开发方面的阻力。因此，与经验丰富的全球技术合作伙伴或合同开发与制造机构(CDMO)建立合作关系，往往对于生产商实现创新基因治疗制剂的量产至关重要。

相关视频

Slide 1 of 8
Selecting The Right CMO
Selecting The Right CMO
Partnering with a CMO may be the quickest and most efficient way to produce your therapy
Reducing The Risk of Gene Therapy
Reducing The Risk of Gene Therapy
Managing uncertainties can help you avoid regulatory risks
3 Cost Modeling Insights to Reduce Gene Therapy Manufacturing Costs
3 Cost Modeling Insights to Reduce Gene Therapy Manufacturing Costs
Manufacturing costs present a key challenge to gene therapy commercialization
Process Development Mistakes
Process Development Mistakes
There is a sense of urgency to produce curative therapies for genetic diseases, but costly mistakes can happen when rushing through process development
Assuring Viral Safety
Assuring Viral Safety
Adventitious viruses may contaminate production processes
Intensified Virus Purification
Intensified Virus Purification
Often the virus size is too large to enter the bead pores resulting in low dynamic binding capacity
Efficient DNA Clearance
Efficient DNA Clearance
Benzonase® nuclease efficiently digests DNA and RNA into fragments smaller than 5 base pairs
Start Right to Scale Right
Start Right to Scale Right
Successfully scale your gene therapy production by implementing a platform process from the start.

相关产品资源

文章：保证基因治疗病毒载体的供应
文章：基因治疗制剂生产发展的一波三折
文章：基因治疗制剂：攻克基因治疗制剂生产的最大难题
文章：一种规模不可能满足全部需求：充分利用基因治疗制剂生产中的多种技术供应商

文章：基因治疗制剂未来十年的发展展望
文章：2020之后：预测基因治疗制剂的未来发展
信息图：让罕见病治疗制剂不再稀缺(Labiotech)
文章：区域化和大众化普及细胞和基因疗法
文章：一览基因疗法的价值驱动型一体化解决方案
海报： 基于成本建模的AAV工艺开发指南

基因治疗制剂开发：培养、纯化、配制

工作流程

Viral Vector Upstream Processing

病毒载体上游工艺流程

Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance 

Viral Vector Downstream Processing

Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs

Viral Vector Formulation and Final Fill

Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise

Viral Vector Characterization and Biosafety Testing

Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability

Viral Vector Contract Development and Manufacturing

CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization

相关应用
细胞疗法生产
引入新型细胞疗法依赖于上下游加工、工艺开发、测试和生产等各个环节的优化。因此，世界级的产品和合作伙伴对于疗法开发的成败和速度，确保其安全高效、经济实惠意义重大。
相关服务
病毒载体CTDMO服务
我们加州卡尔斯巴德市的病毒和基因治疗制剂生产基地拥有齐全的服务项目、先进的cGMP设施和深厚的合规知识，20多年来生产了1000多批次的病毒产品，均能满足严苛的时间线要求。
从细胞培养基到制成品过滤的基因治疗制剂工艺参考图
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