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Gene therapy manufacturing

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高盐裂解配合耐高盐核酸内切酶优化AAV生产工艺
本文介绍了细胞裂解的主要考虑因素,以及如何通过高盐浓度配合耐高盐核酸内切酶提高AAV载体生产工艺的病毒滴度和感染能力。
病毒载体特征鉴定和生物安全性
基因疗法在供患者使用前,需要进行生物安全性检验以确定产品安全性,同时还需了解相应工艺。
病毒载体合同开发与制造
专业的病毒载体药物生产需要价值不菲的技术专长,还需通过与经验丰富的合同制造商合作来确保安全性和合规性,从而降低相关成本。
病毒载体下游处理
新型基因疗法促使下游操作需要可扩展的纯化技术,以提高产量和处理能力。
病毒载体配制、过滤和填充
配制符合监管要求的基因疗法,优化下游流程,以实现可重复的产品质量、安全性、产量和纯度。
病毒载体上游工艺流程
复杂的病毒载体生产工艺上游决策会影响下游工艺。原料、培养基和储存方式的选择都可能对结果产生重大影响。
Gene Therapy Manufacturing
Gene therapy innovation requires integrated manufacturing, testing, safety, and compliance expertise from experienced partners.
基因治疗制剂生产_生物制药生产-默克生命科学
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。
Building Regional Cell Culture Media Supply Chains
Ensure reliable cell culture media supply with our continuously expanding global network of regional sites for resilient biopharma manufacturing.
AAV Process Intensification Using High Salt Lysis and Salt Tolerant Endonuclease
This page describes key considerations for cell lysis and how the combination of a high salt concentration and a salt tolerant endonuclease can be used to increase vector titer and infectivity during AAV vector manufacturing.
Development and Optimization of a Lentivirus Manufacturing Platform
Learn how development of a suspension adapted HEK293T cell line with accompanying cell culture media can maximize lentivirus production for cell and gene therapies.
Lentivirus Platform: Optimizing Performance for De-Risked Production
Learn how the VirusExpress® lentivirus platform utilizes DoE experiments and supplementary studies to optimize workflows, enhance yield, and ensure quality in cell and gene therapies.
Lentivirus Harvest Clarification Process for Cell & Gene
Explore lentivirus harvest clarification options for viral therapy production using suspension cell lines in manufacturing platform development.
DNA/RNA Removal in Viral Production
Benzonase®endonuclease efficiently removes nucleic acid contaminants from viral production, crucial for cell and gene therapies and vaccines.
Strategies for the Separation and Analysis of Empty and Filled Capsids During Viral Vector Production
Explore strategies for separating empty and filled capsids in viral vector production. Learn about upstream strategies and how trends in AAV capsid design impact purification.
Bioprocessing Bag Films: Key Characteristics & Properties
Leak-Proof Bioprocessing Bags. Stronger Films, Better Results, Lower Costs.
Membrane Filtration: Efficient Particle Retention and Bioburden Reduction in Bioprocessing Fluid Streams
Some prefilters reduce bioburden and can be used as a cost-effective alternative to sterilizing filters for bioburden control in bioprocessing.
Promote Optimal Cell Growth with Single-Use Bioprocessing Film
Bioprocessing film designed for cell culture. Switch to Irgafos®168 free bioreactor bags to optimize cell growth and productivity.
Bioreactor Process Development and Scale-Up for Transient Transfection-Based Lentivirus Manufacturing in Suspension Cell Culture
A step-by-step overview of suspension-based, transient transfection bioreactor process development and scaleup of lentivirus production.
Scalability Challenges of Viral Vector Manufacturing
Scaling up viral vector production using adherent cell culture systems is challenging. Learn how suspension cell culture systems benefit large-scale bioprocessing.
Bioprocessing And Scale-Up Of Suspension HEK293 Cells For AAV Manufacturing
To address scalability challenges of AAV manufacturing, we developed an HEK293 suspension cell line that can be used across many serotypes. Get the data in this article.
Development of a Novel Sf9 Rhabdovirus-Negative Cell Line (Sf-RVN®) and Companion Chemically Defined Medium
See how the Sf9 rhabdovirus-free cell line was developed and how we’ve developed a companion chemically-defined insect cell media for protein and viral expression.
Holistic Approach to Optimize Viral Vector Harvest
Webinar explores challenges and solutions in viral vector harvest for bioprocessing.
NGS Identity Testing for Viral Gene Therapies
Webinar discusses risk mitigation testing strategies for viral vector identity confirmation after unexpected sequence variants.
Gene Therapy: R&D to IND Regulatory Navigation
Advance gene therapy efficiently with insights from experts on implementing a "right first time" testing strategy in limited resources.
Rapid Adenovirus Detection: Lot Release
Webinar introduces rapid RCA detection assay combining culture assay with molecular endpoint for replication competent adenovirus.
AAV Gene Therapy Potential
Ensure AAV safety in drug development journey, speeding clinic readiness for more effective disease treatment.
Viral Vector Characterization & Biosafety
Gene therapy demands biosafety testing for product safety and process understanding before patient use.
Viral Vector Downstream Processing
New gene therapies drive the need for scalable purification technologies in downstream operations for higher yield and throughput.
Viral Vector Formulation, Filtration & Filling
Formulate gene therapies to meet regulatory requirements, optimizing downstream processes for reproducible product quality, safety, yield, and purity.
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