Newsletter | October 19, 2026

10.19.26 -- Next-Generation Molecules Challenge Notions Of Yield And Performance

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The body as a bioreactor

What if therapeutic production could move from the facility into the patient? Explore how advances in lipid nanoparticle design, delivery science, and manufacturing are helping bring the body-as-a-bioreactor vision closer to reality—and reshaping what may be possible for genomic medicine.

FOCUS ON UPSTREAM MANUFACTURING

Next-Generation Molecules Challenge Notions Of Yield And Performance

In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss how the process-related associated with next-generation molecules like bispecifics and trispecifics complicate downstream purification efforts impurities (e.g., chain mispairings). They agree that mitigating these impurities is a developmental challenge both upstream and downstream.

A Comprehensive Solution For Adventitious Agent Testing

Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

Extracellular Vesicle Isolation From Conditioned Media

Explore a scalable, sterile solution for isolating extracellular vesicles (EVs) in exosome therapeutics to enhance yield, purity, and commercial viability through innovative filtration technology.

Enabling 2-4x EV Yield Improvements In Bioreactor Culture

A chemically defined fed-batch bioprocess medium simplifies hMSC-EV production, increasing yields while maintaining EV quality across donors and tissue types in scalable GMP-compatible environments.

Beyond High Titers: Expanding A Generalized Host Engineering Tool

Sequential genetic integration can equip stable cell lines with multiple functions. Uncover applications spanning antibody production, glycosylation control, receptor knockdown, and lentiviral packaging.

High-Sensitivity Residual E. coli DNA Testing Supporting Biologics

Advancements in high-sensitivity residual DNA testing enhance the precision of plasmid DNA purity analysis, ensuring compliance with regulatory standards critical for manufacturing processes.

A Hub For Life Sciences Drug Development

Middlesex County, NJ, is a hotbed for the life sciences, offering a deep talent pool, an extensive R&D presence, and dedicated backing by local government in the form of strategic investment.

Optimizing Bispecific Antibody Expression Via Multi-Omics Analysis

Discover how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

Overcoming Regulatory Hurdles In AAV Production

Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Examine how specialized assays and strategic partnerships streamline compliance.

Media And Buffer Mixing Using A Magnetic Mixer

A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

Novel Plasmids And Optimized HEK293 Cell Line Improves AAV Productivity

Low AAV productivity and lack of platform processes continue to drive AAV production costs up. Take a look at a robust and scalable suspension manufacturing platform for AAV production.

UPSTREAM MANUFACTURING SOLUTIONS

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Single-Use Cell Processing Platform - CARR Biosystems

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Stable Cell Line Development For Complex Biologics - Catalent

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The Glycoengineering Toolbox: Matched GMP Enzymes And Sugars - Roche CustomBiotech

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Automated Hydration System - FUJIFILM Biosciences

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Advance The Potential Of Your Cell Culture - Roche CustomBiotech

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Webinar: Maintaining Process Consistency and Performance During N-1 Perfusion Scale-Up

Scaling an intensified N-1 perfusion process from bench to pilot scale can present challenges. Drawing on collaborative work conducted across 5 L, 50 L, and 500 L bioreactor scales, experts will share how consistent culture performance, cell growth, and monoclonal antibody production were maintained throughout scale-up. Gain practical insights into the key considerations, challenges, and strategies for successfully transferring intensified upstream processes toward larger-scale manufacturing.

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Webinar: Scaling ADC manufacturing without compromising quality

Scaling ADC programs from clinical to commercial manufacturing brings new challenges in mixing, solvent distribution, hydrophobicity, and process control. This webinar explores practical strategies and digital tools to reduce scale-up risk, including CFD modeling for conjugation, membrane strategies for TFF, and SIMCA®-online for multivariate process control, batch genealogy, and golden batch monitoring. Discover approaches to improve consistency, robustness, and efficiency across ADC manufacturing. Click here to learn more.

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