Newsletter | September 15, 2025

09.15.25 -- Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond

SPONSOR

Webinar: From Diagnosis to Dose in 14 Months: Accelerating Gene Therapy

Discover the inspiring story of how the Krueger family, with the help of Andelyn Biosciences and leading gene therapy experts, developed a treatment for their daughter’s ultra-rare condition in just 14 months—defying timelines. This webinar reveals the power of patient-led advocacy, cutting-edge AAV manufacturing, and bold partnerships, offering a replicable roadmap for rare disease communities seeking faster cures. Click here to learn more.

FOCUS ON OUTSOURCING

Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond

Contract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.

Overcoming Challenges: Optimize And De-Risk Your mRNA Product Manufacture

mRNA therapy and vaccine manufacturing can become complex and challenging when working with multiple CMOs. Partnering with an end-to-end CMO is key to overcoming the challenges of mRNA manufacturing.

Dispelling Common Clinical Trial Oversight Myths

Many clinical trial oversight problems can be avoided or mitigated by sponsor understanding root causes and being a proactive collaborator with its partners.

Gene Therapy In-Use And Device Compatibility Studies

Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

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.

The Evolution Of AAV Production: Scaling Through Nature Instead Of Brute Force

Evaluate the performance and productivity of VintaProcess in addressing the persistent manufacturing challenges in AAV gene therapy production.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered TARGATT™ landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Scalability Of A Flexible, High-Producing Triple-Transfection rAAV Platform

Explore a demonstration of a scalable, high-yield triple-transfection rAAV platform's flexibility and efficiency, enabling gene therapy production with robust performance metrics and streamlined processes.

The Next Frontier: Industrializing Cell Therapy Manufacturing

Learn how leveraging platform processes can enable flexible service at each level – pre-clinical through commercial – and reduce development timelines and costs on the path to market.

Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids

Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

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Discover how allogeneic NK cell therapies are reshaping cancer immunotherapy! Join Cell & Gene's Erin Harris as she hosts industry leaders for a dynamic discussion on their groundbreaking, complementary approaches. Don’t miss this inside look at the future of cell therapy—Register now for free! This event is supported by ThermoFisher Scientific.

OUTSOURCING SOLUTIONS

Minaris Advanced Therapies Capacity Update July 2025: Cell & Gene Therapy - Minaris Advanced Therapies

Alcami Capacity Update July 2025: Analytical Services - Alcami

Inspiring Waves Of Change - SK pharmteco

Analytical Control Strategy For Your Product Lifecycle - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services - FUJIFILM Biotechnologies

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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