INSIGHTS ON DOWNSTREAM MANUFACTURING

• Performing Virus Clearance Studies With Retroviral-Like Particles: Updated Guidance

  Updated regulatory standards now support using non-infectious retroviral-like particles for viral clearance. This shift reduces costs and accelerates timelines for biomanufacturers.

• A Gentler Workflow: Fc-fusion Protein Purification With Mixed-Mode And Anion Exchange Chromatography

  Gain insights into comparative performance, workflow flexibility, and practical considerations for implementing a new weak anion exchange hydrophobic resin and a strong anion exchange resin.

• WuXiHigh 2.0 Delivers A 180 mg/mL Formula

  This case study shows how smart formulation and integrated development achieved a stable 180 mg/mL biologic for subcutaneous delivery, for teams tackling concentration issues.

• Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing

  See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.

• Ensure Successful Viral Clearance

  3/26/2026

  A decade of viral clearance data comparing established and emerging operations, highlighting LRV performance, key process risks, and practical insights to strengthen downstream safety.

• AST Origins: Pioneering RTU Flexibility With Robotic Fill-Finish Systems

  3/25/2026

  Modernize sterile manufacturing with robotic fill-finish systems. Achieve multi-format flexibility and risk reduction to meet the rigorous demands of personalized medicine and small-batch production.

• To 10X & Beyond, AgentV™-DSP Arrives Ready To Rock

  3/25/2026

  Filter fouling has limited exosome therapeutic scalability—until now. Explore how a breakthrough reagent achieves 50% particle recovery versus 5% traditionally, enabling affordable clinical manufacturing.

• EV Content vs. Function: Using Analytical Tools To Reveal The Connection

  3/25/2026

  See how downstream processing affects CD73 expression and function on MSC-EVs through orthogonal analytical methods that connect vesicle content to biological activity and therapeutic potential.

• Introducing AgentV: A Scalable Solution For 10X Exosome Yield

  3/25/2026

  Understand how a downstream treatment prevents filter fouling during exosome purification, enabling 40-70% particle recovery compared to traditional 5-10% yields while maintaining quality attributes.