Newsletter | September 23, 2026

09.23.26 -- Risk Managing Through The Void Of ATMP Visible Particle Guidance

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Evaluation of a New Multimodal Resin for Emerging Biotherapeutics

As biotherapeutics become more complex, purification scientists need flexibility for process optimization. This 15-minute on-demand webcast, Merck & Co., Inc., presents how Bio-Rad’s Nuvia™ wPrime 2A Media, a weak anion exchange and hydrophobic interaction chromatography (AEX-HIC) mixed-mode resin, provides a broad design space and improved yields while reducing aggregates and HCPs in comparison to existing monoclonal and bispecific antibody workflows. Watch now and request a sample.

FOCUS ON DOWNSTREAM MANUFACTURING

Risk Managing Through The Void Of ATMP Visible Particle Guidance

Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.

 

 

Scalable Purification Strategies For Antibody-Drug Conjugates

Mixed mode chromatography offers a targeted way to control ADC aggregates and DAR profiles. Learn how tuning key parameters and leveraging hydroxyapatite polishing can improve selectivity.

 

Life Cycle Assessment (LCA): Empowering Sustainable Decisions

See how Life Cycle Assessment converts environmental data into practical insights, helping improve product development, sustainability strategies, and decision-making.

 

Analysis Of ADCs Using Hydrophobic Interaction Chromatography

Accurate DAR analysis in HIC requires systems that withstand corrosive salt conditions. Bioinert flow paths and baseline correction tools improve reproducibility, enabling confident characterization of ADCs.

 

Comparing Process Development Approaches For Recombinant Proteins

Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

 

Complex Molecules: A New Chapter For The Biologics Industry

Discover how novel affinity resins address purification challenges for complex antibodies, such as bispecifics and fragments, by preventing aggregation and targeting alternative binding domains.

 

Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing

Uncover 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.

DOWNSTREAM MANUFACTURING SOLUTIONS

The Single-Use Platform Revolutionizing Antibody Production - W.L. Gore & Associates

Oligonucleotide Synthesis Solutions - KNAUER

Drug Product Filtration System - Cytiva

FOCUS ON FILL-FINISH

 

Reducing The Bioburden Load In Drug Formulation And Filling

Sterile drug manufacturing requires preventing and removing contamination. Multi-stage filtration cuts microbial load, protects final filters, and supports quality, efficiency, and patient safety.

 

Safeguarding Biologic Integrity Through Enhanced Component Compatibility

For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

FILL-FINISH SOLUTIONS

A Look At Sterile Injectable Expansion - Simtra BioPharma Solutions

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