Newsletter | October 6, 2025

10.06.25 -- Defining Strong Program Management In CDMO Partnerships

SPONSOR

Webinar: From Plasmids to Cell-free DNA using Megabulb DNA

This Touchlight and ElevateBio webinar explores how non-viral methods are transforming T cell engineering by overcoming cost, safety, and scalability challenges of viral transduction. Speakers highlight CRISPR-based editing with mbDNA™ paired with Life Edit’s LEG14 nuclease. Data show mbDNA™ enabled efficient, precise TCR knock-in with superior performance over Nanoplasmid™, offering a scalable path to next-generation T cell therapies. Click here to learn more.

FOCUS ON OUTSOURCING

Defining Strong Program Management In CDMO Partnerships

This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.

Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

This session is designed for teams developing new products, optimizing processes, or preparing regulatory submissions, and will provide practical tools for a better approach to E&L management.

Impact Of Media Selection

To highlight the importance of media selection, a study was conducted assessing the effect of three commercially available cGMP grade medias and their influence on T-cell phenotype.

Patient Selection By Anti-AAV Total Antibody Binding

Advance the future of medicine by harnessing AAV-based gene therapies — powerful delivery systems that drive safer, more effective, and potentially curative treatments for genetic disorders.

Part Of ARM: Advancing The Future Of Regenerative Medicine Together

With hundreds of members spanning over 25 countries, ARM serves as a hub for innovation, policy development, and cross-sector collaboration in regenerative medicine.

The Continuation Of A Journey

One family managed to combine resources and people to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

The Advantages Of Off-The-Shelf GMP iPSCs With A DMF

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

Taking A Look At AAV Production Using HEK293 In A Perfusion Process

A unique, scalable, and cost-effective approach to generating AAV viral vectors leverages a high-performing cell line, optimized reagents, and purpose-built technology.

SPONSOR

As focus shifts from oncology, autoimmune cell therapies stand poised to lead the next frontier of cell therapy innovation. The 3rd Cell Therapy for Autoimmune Summit returns with the latest data and strategies to translate this promise into patient breakthroughs. Hear directly from scientific pioneers at Cabaletta Bio, Kyverna, Cartesian, Century Therapeutics, Artiva Bio and Novartis, to propel your lead candidate to clinical success.

OUTSOURCING SOLUTIONS

Enabling Advanced Bioprocessing: Solutions That Challenge The Status Quo - Repligen

Cell And Gene Therapy Analytical Services - AGC Biologics

Oncology CRO Helping To Bring Cancer Therapies To Patients - Catalyst Oncology

With Passion We Bring Pharmaceutical Solutions To Life - IDT Biologika

SPONSOR

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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