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Solutions for pDNA / mRNA Manufacturing

质粒DNA作为起始材料,用于mRNA或病毒载体的生产,如慢病毒和腺相关病毒(AAV)载体。

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ACCELERATING pDNA / mRNA MANUFACTURING

End-to-end manufacturing solutions

With the proven success of mRNA-based vaccines in addressing the Covid-19 pandemic, mRNA technology is at the forefront of transforming the world of medicine, and the biopharma industry has ongoing clinical trials to develop both vaccines and therapies to treat infectious diseases and even cancer. pDNA is a critical raw material and acts as a template for mRNA manufacturing. Although cell-free, the IVT mRNA process workflow is impacted by low process yields and scalability challenges. Repligen technologies are uniquely suited to help overcome these challenges in process development and manufacturing at the commercial scale for pDNA and mRNA.

挑战
解决方案

Global high demand

  • Scalability and cost effectiveness
  • Accelerate speed to market
  • Shear sensitivity
  • Low productivity and purification yield

Increased pDNA and mRNA yield
Optimized vector production

  • pDNA: Intensify microbial growth for pDNA production with perfusion-based technology
  • Simplify manufacturing process by replacing centrifugation with microfiltration TFF
  • On-line pDNA product purity monitoring (Process Analytical Technology)

Fully scalable Chromatography and TFF equipment designed for low shear and low hold-up volume performance, maximizing product purity and recovery

Product quality 
Product quality and purity

  • pDNA: open circular pDNA removal
  • mRNA: removal of rDNA, dsRNA, RNA fragments,
    non-encapsulated LNPs

Increased pDNA and mRNA quality

  • Fully sterile and closed automated systems with single-use flow paths
  • Pre-packed columns enable purification and process consistency
  • Analytical in-line technology 

Limited process knowledge

  • Limited scale-up process and implementation experience
  • Lack of in-line process monitoring for cell and cellfree platforms

Expert consultation
Hands-on process and implementation approach from recognized Gene Therapy, oncolytic and vaccines industry experts

 

pDNA/mRNA MANUFACTURING TECHNOLOGIES

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XCell ATF® Systems

  • Scalable, single-use cell retention
  • Higher viable cell density and total pDNA titer

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中空纤维过滤器

  • Wide range of membrane formats, chemistries and pore sizes
  • Recommended MWCO for TFF1: 10-300 kDa

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SIUS® Gamma Flat Sheet Cassettes

  • Fully assembled, irradiated cassettes for high flux performance and reduced process time
  • Recommended MWCO: 10-300 kDa

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KrosFlo® TFF 系统

  • Automated hollow fiber or flat sheet TFF
  • Ideal for shear-sensitive vectors with low hold-up volume

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OPUS® 预装柱

  • Broad range covering process development and commercial manufacturing requirements
  • Pack any resin for plasmid and mRNA purification

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KRM™ 层析系统

  • Superior gradient control, higher peak resolution, high yield
  • Ready-to-operate single-use flow path

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FlowVPX® Device

  • In-line PAT monitoring in downstream
  • Applications in pDNA, mRNA and LNP manufacturing

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流体管理系统

  • State-of-the-art valve and tubing technology
  • Designed-for-purpose transfer and containment assemblies

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ProConnex®
流路

  • Single-use, sterile, configurable flow paths
  • Plug and play fluid management

Repligen technical support Ensures success

具有基因治疗专业知识的 Repligen 现场应用专家 (FAS) 可为全球客户提供从咨询到操作的全方位支持。

咨询

  • 理论
  • 技术适配性
  • 实验计划

评估

  • 示范
  • 培训
  • 数据分析

开发

  • Optimization
  • 流路选型
  • 系统选型

使用

  • 规模放大
  • 验证
  • 长期培训计划

资源

全部展开

Lentiviral vector manufacturing process enchancement utilizing TFDF® technology
Thomas Williams、Oliver Goodyear、Lee Davies、Carol Knevelman、Michael Bransby、Kyriacos Mitrophanous & James Miskin
Cell and Gene Therapy Insights, 2020年4月

Gene Therapy Manufacturing
René Gantier, PhD, 基因治疗技术总监, Repligen Corporation 

Repligen Corporation
2021年4月

使用封闭式、预辐照的一次性使用平板TFF设备进行AAV研究David Bianchi, Carl Breuning, Michael LaBreck, Shelly Parra, Mary Jo Wojtusik, Repligen Corporation 
Alex Meola, Michael Mercaldi, Thomas Thiers, Homology, Medicines Inc. 

Repligen Corporation
Homology, Medicines Inc.
2020年7月