Repligen已准备好与基因疗法开发商和生产商合作，为质粒和病毒载体的生产提供突破性技术和极具影响力的解决方案。
Repligen solutions from gene to therapy
Gene Therapy has immense potential to transform the lives of patients with genetic diseases. As demand for plasmids and viral vectors outpace capacity, a greater than 10-fold and potentially close to 100-fold increase in manufacturing efficiency for the gene therapy reagents is likely required to meet a demand curve that is increasing exponentially. Repligen solutions aim to meet the needs for optimized processes, higher yields, and improved process quality - setting new standards for modern scalable processes from gene to therapy.
Leading Gene Therapy Manufacturing 2.0
Repligen is in a unique position to lead Gene Therapy Manufacturing 2.0, where the viral vectors will be continuously produced from producer cells, using intensified suspension cell culture ran in perfusion mode, and purified through a secured and high efficiency downstream process.
Repligen是基因治疗应用的技术和市场领导者
广泛的客户基础，包括临床前到III期临床候选药物厂商、CDMO、治疗开发商、学术机构/医院
被多种技术平台采用，包括质粒、AAV、慢病毒、mRNA、CRISPR、CAR-T
适合基因治疗的工作流解决方案
新的解决方案，用于上游工艺强化以及质粒、病毒和非病毒载体的下游工艺
封闭式系统生物工艺 –一次性使用、伽马辐照、全整合式流路
可放大的平台支持从实验室工艺开发到商品化规模生产
专注于质量 – ISO 9001:2015 生产
Workflow solutions for gene therapy
需求和挑战：
- 自动化操作、标准化硬件平台
- 一次性使用技术，确保封闭式系统生物工艺，消除交叉污染风险
- 工艺现代化/优化，提高产物产量和产物质量
- 稳健的分析技术，标准化固有的分析差异性
REPLIGEN technical support ENSUres Success
Repligen Field Application Specialists (FAS) with expertise in Gene Therapy provide support from consultation to implementation globally.
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
- Flow Path sizing
- 系统选型
使用
- 规模放大
- 验证
- Long-term training plan
资源
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
Viral Vector and Plasmid Quantitation Analytics for Accelerated Gene Therapy Time to Market
August 21, 2020
Technology-ready processes for Gene Therapy Manufacturing 2.0
May 12, 2020
Automated High Throughput Viral Vector Purification to Streamline Downstream Process Development in Gene Therapy
May 12, 2020
AAV Studies Deploying a Closed, Irradiated, Single-use Flat Sheet TFF Device
by 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.
July 2020