Newsletter | October 6, 2026

10.06.26 -- Inside Scaling Next-Gen MSCs Without Scaling Risk

SPONSOR

 

Maximize Exosome Yields Using a Chemically Defined Bioreactor Media System

How can MSC-derived exosome manufacturing achieve greater yields without adding complexity? This RoosterBio webinar introduces RoosterHD-EV, a chemically defined, xeno-free, fed-batch media system designed for streamlined manufacturing from seeding through harvest. Explore how process intensification can simplify workflows, increase manufacturing flexibility, enable paired cell and exosome harvest, and deliver a 10- to 20-fold improvement in overall process yields. Click here to learn more.

FOCUS ON MANUFACTURING

Inside Scaling Next-Gen MSCs Without Scaling Risk

Here's why scaling MSC therapies requires maintaining product consistency, potency, and comparability as manufacturing evolves.

 

 

The Proven, Practical Gateway To Upstream Process Intensification

N-1 perfusion increases inoculum density and speeds production without altering fed-batch processes. Discover a practical path to lower costs and higher yields in biologics manufacturing.

 

Characterization Of Tumor-Specific T-Cells With Modifications

Explore a scalable RNA-seq approach that delivers reproducible, high-quality transcriptomic data from checkpoint-edited T-cells, uncovering gene expression changes linked to PD-1 and TIGIT deletion.

 

CRISPR-Cas9 KO Cell Line Generation And Development

See how CRISPR-generated FKRP knockout muscle cells and a high-throughput On-Cell Western method can quantify α-dystroglycan glycosylation restoration and support rAAV-FKRP potency testing.

 

"Bestcellers": Controlled Filling & Freezing Of Cells

Cell culture freezing requires precise fluid controls to safeguard viability. Examine advanced fluid management methods for cell banking, cell therapy, and large-scale cryogenic workflows.

 

Cost Modeling Analysis Of AAV And LV Manufacturing

Scale plays a pivotal role in viral vector economics. Compare intermediate-scale AAV and LV manufacturing scenarios to pinpoint effective strategies for reducing risk and total cost.

 

Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up

Scaling up lipid nanoparticles requires evaluating key fluid dynamics. Compare the trade-offs between laminar microfluidics and turbulent mixing to select the right scale-up strategy.

 

Scalable Bioreactor Strategies For Targeted Exosome Delivery

Engineered exosomes displaying tumor-homing peptides offer a promising tool for targeted cytotoxic drug delivery. See how stirred-tank bioreactor systems scale production efficiently for critical research.

 

Clearing DNA Impurities In AAV And LVV Vector Manufacturing

Endonucleases are essential for clearing DNA impurities in viral vector manufacturing. Learn how a new enzyme compares to other commercially available options in AAV and LVV production.

 

Shifting Biomanufacturing From Rigid Setups To Plug-And-Produce

Legacy biomanufacturing relies on rigid, custom operations. Modular automation, integrated sensors, and plug-and-produce designs create adaptable, efficient facilities.

 

Quality Equipment Design Proven Through Testing

Rigorous multi-cycle stress testing and environmental validation ensure manufacturing hardware delivers uncompromising reliability for critical processing workflows.

 

DNA Quality As A Manufacturing Variable: What Sponsors Need To Know

Traditional plasmid DNA manufacturing introduces biological impurities and structural variability that lower viral titers. Transitioning to cell-free synthetic DNA platforms ensures sequence fidelity.

 

The Fast Track To Global Expansion: Consistency Across Every Site

Operational consistency across global facilities protects product integrity and supports growth. Standardized processes reduce risk, minimize variability, and strengthen quality across markets.

 

Overcoming Challenges To The Commercialization Of Lentiviral-Based Therapies

Commercializing lentiviral therapies requires robust expression. Review performance data from suspension cell lines using transient transfection in chemically-defined, animal-free media.

 

Implementing AI Systems In Regulated Pharma Environments

Explore how AI can be safely and effectively deployed in regulated pharma environments, with practical guidance on risk, governance, and lifecycle management rooted in GAMP 5 principles.

SPONSOR

 

Webinar: Viral Vector for Rare and Ultra-rare Disease

Rare and ultra-rare disease programs require viral vector strategies tailored to smaller patient populations. Explore practical approaches to right-size development and manufacturing, determine appropriate scale, reduce costs and timelines, and align processes with clinical and commercial needs. This webinar will share practical strategies for leveraging manufacturing partners and advancing toward proof of concept and clinical validation efficiently and cost-effectively.  Click here to learn more.

MANUFACTURING SOLUTIONS

•

Fluid Management Solutions For Precision, Scalability, And Reliability - CPC Biotech

•

Workflows For T-Cell Isolation And Activation - Thermo Fisher Scientific Bioproduction

•

Standardize Your Process With An Automated Solution - Cytiva

•

Single-Use Tubular Bowl Centrifuge Platform For High Cell Viability - CARR Biosystems

•

Innovating Upstream AAV Manufacturing For The Next Wave Of Gene Therapies - Mirus Bio

•

Custom GMP-Grade Protein Services - ACROBiosystems

Connect With Cell & Gene: