Newsletter | September 25, 2025

09.25.25 -- Engineering Off-The-Shelf Cell Therapies For Cancer & Autoimmune Disease

SPONSOR

Webinar: Achieving Flexibility In T Cell Manufacturing - Adaptation Of Standardized Processes

Join Miltenyi Bioindustry’s expert-led webinar to explore how the gold-standard T Cell Transduction (TCT) process on the CliniMACS Prodigy® platform is transforming CAR-T manufacturing. Discover scalable, standardized solutions to accelerate production while preserving potency. Gain insights into G-Rex® integration, process development support, and in-depth analysis of expansion, efficiency, exhaustion, and tumor-killing performance to advance your cell therapy programs. Click here to learn more.

FOCUS ON MANUFACTURING

Engineering Off-The-Shelf Cell Therapies For Cancer And Autoimmune Disease With Ernexa Therapeutics' Sanjeev Luther

On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Ernexa Therapeutics' President and CEO, Sanjeev Luther, about how the company is advancing cell therapy innovation for cancer and autoimmune disease through engineered induced pluripotent stem cell-derived mesenchymal stem cells (iMSCs).

The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

De-Risking CHO Cell Line Development With Automation And Predictive Modeling

Discover how high-throughput, single-cell technologies combined with machine learning and automation are transforming clone selection to accelerate timelines and improve accuracy in bioprocessing.

Toward A Gene Therapy Platform: What's The Best Format Of TFF?

Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.

Release By Exception Saves Time And Money In QC Activities

Release by exception reduces the manpower needed for reviewing QC batch information, only requiring quality teams to review information when predefined targets are not met and lowering costs.

Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

A Closed Solution For T Cell Isolation And Activation

We outline the incorporation of magnetic bead separation technology into a cell processing platform designed specifically for cell therapy applications.

One HEK Of A Viral Vector To Develop

Here we explore the use of viral vectors in gene therapies, as well as factors that negatively affect them during manufacturing.

Why Cell Washing Is The Hidden Bottleneck In Gene-Edited Cell Therapy

Scaling up life-saving gene-edited cell therapies means tackling production inefficiencies. Overcoming the time-consuming and risky cell washing step is crucial for clinical and commercial success.

Optimized Production Of Recombinant Proteins

Advancements in recombinant protein production have improved efficiency and quality. However, optimizing cell culture media remains crucial to ensuring maximized yield and desirable product attributes.

The Case For Modernizing Small-Volume Aseptic Processing

Tube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.

Accelerating The Industrialization Of CGT Manufacturing

Patent expiry of original product enables 3P innovation to design enhanced equivalent DPI filling system for developers and CMOs.

MANUFACTURING SOLUTIONS

Cleanroom Technology For Unparalleled Cleanliness And Speed - AES Cleanroom Technology

Early Drug Development Made Easy With Small Quantities - West Pharmaceutical Services, Inc.

GMP Recombinant Human IL-15 - Miltenyi Biotec

SecurityLink™ HPLC/UHPLC Fingertight Fittings - Danaher Life Sciences

Advanced Control Capabilities That Facilitate Automation And Data Management - Eppendorf SE

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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