Newsletter | July 30, 2025

07.30.25 -- Purification Strategies For Multispecifics

FOCUS ON DOWNSTREAM MANUFACTURING

Purification Strategies For Multispecifics

In this segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” our panelists Mark Fitchmun and Dr. Jian Ren debate the use of affinity resins compared to ion exchange and multimodal chromatography methods.

Designing Successful Viral Clearance Studies

Review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns

In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

Streamlining Single-Use Assemblies For Downstream Bulk-Filling

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

Evaluation Of A New Multimodal Anion Exchange Resin

Tackle tough bioseparation challenges head-on. Learn about a new multimodal anion exchange resin, showcasing superior impurity clearance and higher yields for complex and low pI proteins.

DOWNSTREAM MANUFACTURING SOLUTIONS

Protein A Resin With High Binding Capacity - Cytiva

Multi-Method Analysis - Detect Your HCP Impurities - Cygnus Technologies Inc.

FOCUS ON FILL-FINISH

Orphan Drug Development: Fill Finish, Clinical Trials, And Advocacy's Impact

Orphan drug development is a journey marked by challenges at every step. From patient recruitment to aseptic fill finish, overcoming hurdles is critical for bringing life-saving treatments to market.

FILL-FINISH SOLUTIONS

Container Closure Integrity Testing - Lonza

Capacity Update April 2025: Fill/Finish - Curia

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