Newsletter | April 29, 2025

04.29.25 -- The Cell And Gene Therapy Dilemma: Centralized Vs. Decentralized Manufacturing

SPONSOR

Discover the future of iPSC-based therapies in this free Cell & Gene Live digital event. Experts will share insights on emerging applications, regulatory challenges, gene editing advancements, and key safety considerations in scalable iPSC manufacturing. Don't miss this opportunity to hear from leaders at the forefront of regenerative medicine. Supported by Invetech.

FOCUS ON MANUFACTURING

The Cell And Gene Therapy Dilemma: Centralized Vs. Decentralized Manufacturing

This article explores key factors to consider when determining whether a centralized or decentralized model is best suited to support access for a specific CGT product, depending on the condition and context.

Tackling Encapsidated Host Cell DNA To Improve Quality

Discover a cell line that enhances rAAV production by reducing host cell DNA encapsidation, improving safety and efficiency through genetic modifications that inhibit apoptotic DNA fragmentation.

Rapid And Precise Assessment Of AAV Capsid Ratios And Viral Titer

Empty capsids in AAV preparations can reduce efficacy and trigger unwanted immune responses. Droplet Digital PCR offers a fast, precise, and easy way to quantify empty and full capsids in AAV samples.

Depth Filters For The Clarification Of AAV

Explore study results demonstrating the ability of Sartoclear depth filters to deliver high performance for AAV clarification, ensuring scalability, high recovery rates, and robust filtration.

Cell Harvesting: Optimizing Viability And Recovery In Cell Therapy

Learn about a family of centrifuges and review of data collected on the centrifuges' performance for the harvest of cells in cell therapy production.

Challenges Facing Aseptic Manufacturing In The CGT Market

Cell and gene therapies are gaining traction in the biopharmaceutical world, but challenges will inevitably follow. Considerations for aseptic fill/finish are essential as this technology grows.

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.

Automating Ancillary Processes: Closing Bottlenecks In CGT Manufacturing

Watch as speakers share a variety of challenges encountered when closing and automating ancillary processes, and how closed automated platforms improved scalability and reproducibility.

Cell Therapy Scale-Up Strategies For Commercial Success

This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

Tailored Automation And Advanced Technologies For The Next Decade

From personalized treatments to large-scale viral vector production, the future of ATMPs hinges on optimized automation. Delve into the technologies driving this transformation and the challenges ahead.

Risks And Safety Measures For Cytotoxic Compounding

Cytotoxic compounding poses risks like contamination and exposure, causing serious health effects. Safety measures include isolators, PPE, SOPs, and advanced technologies like the Bioquell Qube.

MANUFACTURING SOLUTIONS

High Quality Water - Corning Life Sciences

XCell ATF System: Breaking Productivity Barriers In Upstream Bioprocessing - Repligen

SciVario twin Bioprocess Controller - Eppendorf SE

Optimizing Performance For De-Risked Lentiviral Vector Production - MilliporeSigma

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