Newsletter | September 30, 2026

09.30.26 -- The Levers And Tradeoffs That Drive Process Productivity

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Sterile manufacturing is increasingly a strategic differentiator in drug development, particularly as antibody-drug conjugates (ADCs) add complexity to formulation, fill/finish, and lyophilization. This collection explores critical decisions around in-house manufacturing, outsourcing, and CDMO selection, alongside ADC-specific lyophilization challenges. Technical perspectives on process development, cycle optimization, controlled ice nucleation, drying, and automated visual inspection offer practical guidance for improving efficiency, consistency, and product integrity while reducing risk and accelerating progress toward commercialization. Learn more

FOCUS ON FILL-FINISH

 

Lipid Nanoparticles For Pulmonary Delivery Of mRNA

Gain insight into how nebulized mRNA lipid nanoparticles show preclinical success in lung delivery, offering fresh momentum for inhaled gene therapies targeting respiratory diseases.

 

GLP-1 INJ Solid Phase Peptide Synthesis (SPPS) Workflow

Scale your GLP-1 peptide synthesis efficiently. Discover how automated solid-phase workflows and single-use fluidics maximize crude purity while reducing total solvent consumption.

 

Automated Fill And Finish For Cell Therapy

Automated fill-finish systems protect sensitive cell therapies using low-shear handling to maintain dose uniformity, cell viability, and process consistency across every batch.

 

Early-Phase Injectable Formulation Development

Examine how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

FILL-FINISH SOLUTIONS

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Enzyme Indicator Technology - Protak Scientific Ltd

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Planning For Scale-Up - West Pharmaceutical Services, Inc.

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Bio-Expo Live Downstream Manufacturing Session is a virtual event for biopharma professionals focused on downstream manufacturing solutions. Attendees can discover new equipment and technologies supporting therapeutic areas from ADCs to vaccines through short, interactive presentations with live Q&A. The event is tailored for biopharma companies and contract manufacturers seeking solutions to overcome downstream manufacturing challenges. Register now to reserve your spot!

FOCUS ON DOWNSTREAM MANUFACTURING

The Levers And Tradeoffs That Drive Process Productivity

This virtual panel discussion featured David Scherr, Ph.D., a senior scientist in bioprocessing technologies and engineering at AstraZeneca, and Vadim Klyushnichenko, Ph.D., VP biopharmaceutical development and quality at Calibr-Skaggs Institute for Innovative Medicines. Scherr and Klyushnichenko discussed where productivity gains can be achieved and how development teams can improve process performance by simplifying purification strategies and reducing chromatography steps. 

 

 

Challenges And Solutions In Lyophilization Development For ADCs

Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

 

Keeping mAb Aggregation Low During The Final UF/DF Step

mAb aggregation can arise from molecular properties, process conditions, and equipment‑driven stress. Learn where aggregation risk increases across downstream processing and formulation.

 

Gain Efficiency And Flexibility With Chromatography Resins

Explore a platform that supports intensified purification strategies with high binding capacity, fast throughput, and robust stability, making it ideal for scaling therapeutic production.

 

Unlocking Robust Separations For Modern Peptide Therapeutics

As peptide therapeutics grow more complex, impurity profiling demands greater chromatographic confidence. See how robust reproducibility can support reliable GLP-1 receptor agonist analysis.

 

Titer Analysis In The Era Of Complex Antibody Therapeutics

As antibody formats grow more complex, titer is harder to measure. Chromatography cuts through matrix noise to deliver accurate, scalable quantification from early development through QC.

DOWNSTREAM MANUFACTURING SOLUTIONS

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Bench Scale Tangential Flow Filtration System - Repligen

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Comprehensive Fluid Management And Flow Control Solutions - CPC Biotech

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