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Advanced Platform-Based Bioprocessing

Advanced Platform-Based Bioprocessing

Advanced Platform-Based Bioprocessing

Product catalog summary
Overview
Repligen Corporation provides advanced solutions for gene therapy manufacturing, focusing on process intensification to enhance efficiency and yield. Their technologies address common challenges in gene therapy production, such as low yields, complex workflows, and limited process knowledge.
Challenges
  • Low Yields: Issues include low viable cell density during transfection, multiple harvests, and low purification recovery.
  • Complex Workflows: Challenges involve triple plasmid transfection, high seed train volume, lysate clarification, and inefficient downstream purification.
  • Limited Process Knowledge: There is a lack of standard platforms for various modalities like AAV, Lentivirus, pDNA, and exosomes, along with limited scale-up experience.
Solutions
  • Increased Yield: Enhanced vector production through increased cell density and continuous harvest and clarification.
  • Optimized Purification: High-throughput process development and gene therapy-specific affinity resins.
  • Simplified Workflow: Integration of perfusion and clarification steps with single-use fluid management.
  • Expert Consultation: Hands-on support from industry experts in gene therapy.
Intensification Data
  • 3X AAV8 production and >80X Lentivirus production using KrosFlo® TFDF® System.
  • 167X load volume and 240X total AAV recovery using KRM™ Chromatography System.
Technologies and Products
  • KrosFlo® TFDF® System: Combines perfusion and clarification in one step.
  • ProConnex® Flow Paths: Configurable flow paths for fluid management.
  • Hollow Fiber Filters: Suitable for shear-sensitive molecules like Lentivirus.
  • SIUS® Gamma Flat Sheet Cassettes: High flux performance for AAV concentration.
  • KrosFlo® RS TFF Systems: Automated systems for shear-sensitive vectors.
  • AVIPure® Resins: AAV-specific caustic stable affinity resins.
  • OPUS® Pre-packed Columns: Suitable for AAV, Lentivirus, or plasmid purification.
  • KRM™ Chromatography Systems: Offers superior gradient control and high yield.
  • FlowVPX® Device: In-line PAT monitoring for purification processes.
  • KrosFlo® RPM System: Automated real-time process management.
  • Fluid Management Solutions: Advanced valve and tubing technology for efficient transfer and containment.
Contact Information
Repligen Corporation provides customer service across various locations in Estonia, the Netherlands, and the USA, with contact details available for each region.
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Catalog excerpts

Advanced Platform-Based Bioprocessing-1

Data Sheet End-to-end process-intensified solutions for Gene Therapy Manufacturing Repligen offers unique and innovative technologies with in-depth process expertise to help intensify your gene therapy manufacturing processes at every step of the workflow. Intensified Vector Production Intensified Seed Train UF/DF •♦•Chromatography UF/DF Intensification Data Upstream viral vector production intensification 3X AAV8 production using KrosFlo® TFDF® System > 80X Potent Lentivirus production using KrosFlo1 TFDF® System • Low viable cell density in production bioreactor during transfection • Multiple harvests Complex workflows • Triple plasmids transfection and viral vector production • High seed train volume • Lysate clarification • Inefficient downstream purification Limited process knowledge • Lack of standard platform for various modalities: AAV, Lentivirus, pDNA, exosomes • Limited scale-up and/or implementation experience Increased yield Optimized vector production • Increased viable cell density with process intensification • Continuous harvest and clarification Optimized purification • High-throughput process development for resin optimization • Gene Therapy-specific affinity resins • Low shear/hold-up volume downstream equipment Simplified workflow • Increased viable cell density in N-1 bioreactor • Integrated perfusion and clarification steps • Single-use fluid management Expert consultation implementation support from recognized Gene Therapy industry Scaling rAAV9 Purification with KRM™ Chromatography System 167X load volume into capture column 240X total AAV recovery (VG) © 2023 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or the

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Advanced Platform-Based Bioprocessing-2

Gene Therapy Manufacturing Data Sheet Meet our experts Rachel Legmann Sr. Director of Technology, Gene Therapy KrosFlo® TFDF® System • Perfusion and clarification in one step • Enables multiple harvests and continuous clarification, low shear and hold-up volume ProConnex® Flow Paths • Complete, configurable flow paths • Plug and play fluid management Hollow Fiber Filters • Wide range of membrane formats, chemistries and pore sizes • Ideal for Lentivirus large, shear-sensitive molecules SIUS® Gamma Flat Sheet Cassettes • Fully assembled, irradiated cassettes for high flux performance and reduced...

 Open the catalog to page 2
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