Newsletter | August 18, 2025

08.18.25 -- Commercial Clarity And Communication Will Define The Future Of CGT CDMOs

SPONSOR

Webinar: Breaking Barriers with PCR: Innovative Solutions for Clinical Trial Success

Designing PCR-based testing strategies for clinical trials requires not only technical precision but also thoughtful decisions around assay selection, platform capabilities, and clinical relevance. Join experts from Precision for Medicine, as well as guest speakers from Avidity Biosciences and Indaptus Therapeutics, as they explore how PCR-based molecular monitoring drives smarter, faster, and more efficient personalized clinical trials. Register Now

FOCUS ON OUTSOURCING

Bridging The Disconnect: Commercial Clarity And Communication Will Define The Future Of CGT CDMOs

As the cell and gene therapy sector emerged, large CDMOs ventured into the sector as if it were an easy extension of their biologics or small molecule business. It’s not. And that lack of understanding has created an industrywide bottleneck.

De-Risking Cell Therapy Development: 4 Keys To A Streamlined IND Path

The first in a two-part series focuses on the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 IND application.

How The Pharma Industry Is Closing Health Inequities

Pharma leaders discuss advancing equity through inclusive trial design, access planning, and global partnerships to overcome persistent health disparities and expand access to lifesaving therapies worldwide.

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.

Efficient Mammalian Cell Engineering For Difficult Protein Expression In 4-6 Weeks

By leveraging cells equipped with an existing TARGATT™ landing pad, we demonstrate how inducible expression can be efficiently achieved within just 4-6 weeks after donor plasmid creation.

Streamlining AAV And LVV Manufacturing Platform Solutions

Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.

DoE Approach Suggests Transfection Viable-Cell Density As Key Parameter

Uncover how a Design of Experiment (DoE) model was developed to address the multifactorial nature of large-scale transfection, where variables like viable cell density (VCD) and DNA amount jointly influence efficiency.

Intelligent mRNA Manufacturing Through Process Analytical Technologies

Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.

Seamless Transitions From Bench To CGT Applications

Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

An End-To-End Industrialization Roadmap For Autologous Cell Therapy

Explore specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.

OUTSOURCING SOLUTIONS

Proteins Manufactured Through Mammalian Cell Culture Technology - Novartis Contract Manufacturing

Advantages Of Our Expertise In Proprietary Cell Lines - IDT Biologika

Phase-Appropriate, Tailored Process Development Support - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Advancing Innovative Plasmid DNA Manufacturing Solutions For CGT - Aldevron

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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