Newsletter | October 14, 2025

10.14.25 -- Manufacturing Interleukin-2 For In Vivo Use: Key Considerations

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Meet the Next Evolution of ddPCR Solutions

Introducing Bio-Rad's most advanced Droplet Digital™ PCR (ddPCR™) systems yet — the QX Continuum™ and QX700™ systems series, which set new standards in sensitivity, workflow simplicity, ease of multiplexing, and performance through absolute quantification. Learn More

FOCUS ON MANUFACTURING

Manufacturing Interleukin-2 For In Vivo Use: Key Considerations

Interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Manufacturing success requires stringent control over production, formulation, and stability to ensure safety and efficacy.

Anticipating The Next Decade Of Gene Therapy

Improvements include the development of alternative approaches to gene delivery, advances in upstream and downstream processing, analytical methods, and intensified/continuous processing.

Barrel Filling Vs. Tip Filling A Syringe – Which Approach Should Be Used?

There are two primary filling methods for pre-filled syringes. Delve into the pros and cons of each approach, highlighting why barrel filling is generally preferred in the pharmaceutical industry.

Future-Proofing Aseptic Manufacturing

Investing in adaptable aseptic manufacturing pays off. Find out how flexible systems, despite higher initial costs, handle complex drugs and changing volumes to boost productivity and quality.

Vial Containment Systems For Gene Therapies: Series Summary

Proactively understanding containment system performance can streamline development and accelerate market delivery. Review comparative data for CZ-based systems and traditional glass or polypropylene options.

Unlocking The Potential Of Gamma Delta T Cell-Based Therapies

Learn more about two unique methods for clinical-scale expansion of gamma delta T cells, which are well suited for a wide variety of treatments due to their reduced risk of graft-versus-host disease.

Scalable Expansion And Downstream Processing Of High-Quality hiPSCs

Grasp the insights about a scalable, microcarrier-based 3D culture process for expanding hiPSCs to 10L, yielding over 10 billion cells while maintaining quality.

Next Generation Sequencing In Viral Safety Testing

Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

Exploring Perfusion Technology For Virus Manufacturing Process Intensification

Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

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.

Optimizing Stem Cell Culture Conditions

Uncover how you can revolutionize your stem cell research with a stable, plant-based growth factor that simplifies culture maintenance and boosts cell health.

GMP Process Solutions For MSC-EV Purification With 10X Yield Improvements

Biological components in conditioned media are a consistent problem during downstream processing of EVs. A novel in-process reagent prevents these issues and improves particle recovery 10-fold while maintaining CQAs.

Closing The Loop: A Simple And Scalable Cell Processing Platform

The transition from manual to automated cell processing is vital for therapeutic success. A versatile, single-use system simplifies operations, reduces variability, and ensures product quality throughout manufacturing.

Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines

Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.

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Webinar: Enhancing viral vector sterile filtration: process efficiency and GMP alignment

Sterile filtration is vital to viral vector manufacturing success—impacting yield, quality, and compliance. Join Cytiva to explore advances with Supor™ EKV and Supor™ Prime filters for AAV and lentivirus workflows. Learn how optimized filtration strategies boost recovery and streamline downstream operations, plus gain practical guidance on implementing PUPSIT in line with EU GMP Annex 1. Click here to learn more.

MANUFACTURING SOLUTIONS

A QMS That Helps You Transform Compliance Into A Competitive Advantage - MasterControl, Inc.

Modular Biopharma Cleanrooms - AES Cleanroom Technology

Accelerate Manufacturing With GMP-Compliant Automation Solutions - Invetech

IRO: The New Standard Of CGT Manufacturing - Ori Biotech

A Platform To Transform Cell Therapy Manufacturing - Cytiva

Welders And Sealers That Deliver Dependable, Sterile Results - Terumo BCT

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Join Cell & Gene Live on October 16 at 11am ET for a virtual panel discussion on Designing Early Manufacturing for Long-Term Success in CGT. Registration is free with support from Thermo Fisher Scientific.

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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