Newsletter | November 10, 2025

11.10.25 -- Manager Alignment And Integration: Best Practices When Working With A CDMO

SPONSOR

Webinar: Navigating Innovation and Challenges in Cell and Gene Therapy Bioprocessing

Join Entegris for an expert-led webinar exploring the key factors shaping bioprocessing in cell and gene therapies. Through an engaging panel discussion, industry leaders will share how to select the right processing tools and containers, manage visible particles without affecting cell integrity, and prepare for future trends—from evolving regulatory expectations to the transformative potential of AI in bioprocessing. Click here to learn more.

FOCUS ON OUTSOURCING

Manager Alignment And Integration: Best Practices When Working With A CDMO

This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

Tech Transfer: 8 Typical Stumbling Blocks To Avoid

Ensure a smooth and successful technology transfer by implementing strategic planning, communication, robust training, and clear agreements to optimize your biopharmaceutical manufacturing process.

Improving Methodologies For iPSC Manufacturing And Differentiation

Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.

AAV Purification: Strategies To Improve Recovery And Downstream Quality

This study evaluates filter trains from four vendors, aiming to enhance titer recovery, HCP removal, DNA breakthrough, turbidity reduction, and throughput in gene therapy manufacturing.

Securing A Treatment Through Grit And Collaboration

Discover how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

From Research Stage To GMP Production

Assimilate how to effectively navigate the transition to GMP, ensuring your project meets stringent requirements while streamlining development and minimizing risk.

Improving Viral Vector Production Through Addressing Complexity

In a recent webinar, Novartis Contract Manufacturing experts explored innovations in viral vector manufacturing and addressed production challenges and quality control strategies.

Future Proofing The Cell And Gene Therapy Supply Chain

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

Enhancing The Upstream Performance Of AAV Vector Manufacturing

Unlock the potential of AAV manufacturing by leveraging data-driven insights and the advanced Pro10™ platform to optimize processes, enhance productivity, and drive innovation in cell and gene therapy.

Global Access To Cell And Gene Therapy: ARM Studios Interview

Don’t miss this compelling interview with Boro Dropulić, CEO of Caring Cross, on how the cell and gene therapy sector can turn scientific breakthroughs into global health solutions.

Harnessing Potential: Innovations And Improvements In Viral Gene Therapy

Review the potential of AAV-mediated gene therapy as a platform approach to treat multiple genetic neurological diseases, and explore suggestions to streamline translational studies and reduce costs.

Comparing Synthesis Processes To Establish rAAV Batch Quality

Through a side-by-side evaluation, we present a comprehensive analysis of various published and newly developed dsDNA conversion processes tested using the same sequencing chemistry.

Enabling Gene Therapy Access Using A Cell-Based Companion Diagnostic (CDx)

This study highlights how we overcame developmental challenges by employing a customized approach that leveraged scientific expertise, strategic collaboration, and effective governance.

Streamline Biopharmaceutical Manufacturing With Versatile Platforms

Gain insights into how standardized quality controls, robust analytics, and streamlined processes can improve efficiency, reliability, and scalability across the development lifecycle.

SPONSOR

Join Jon O'Connell and experts on this Cell & Gene Live event, exploring whether minimum viability can help gene therapy developers make smarter sourcing decisions — from research-grade production through clinical and commercial phases, where cost and quality can make or break a product. Registration is free with support from Roche CustomBiotech.

OUTSOURCING SOLUTIONS

Advancing Vaccines From Preclinical Development To Commercial Supply - FUJIFILM Biotechnologies

A Fully Integrated Toolbox For Therapeutic Protein Expression - Lonza

The Future of Cell & Gene - AGC Biologics

Specialized Scientific Expertise In Biologics From 2 Centers Of Excellence In The U.S., Canada - SGS

Expanding Cell & Gene Therapy Global Supply Chain Offerings - Cryoport Systems

cGMP Cell Manufacturing - Applied StemCell

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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