Newsletter | October 13, 2026

10.13.26 -- How CDMOs Are Accelerating RNA Therapeutics From Lab To Clinic

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Webinar: From iPSC Starting Material to Scalable GMP Manufacturing

Developing scalable, high-quality iPSC sources can be complex as cell therapy programs move toward clinical manufacturing. This webinar explores an integrated approach combining GMP iPSC lines, working cell banks, GMP-compatible media, and standardized expansion protocols. Learn how this coordinated system can simplify process development, support reproducible high-volume iPSC feed streams, scale to billions of cells, and enable downstream differentiation. Click here to learn more.

INDUSTRY INSIGHTS

 

Custom Assemblies For Viral Vector Manufacturing

Meeting tight production timelines requires planning and supply chain resilience. Learn how manufacturing coordination supported viral vector production and delivery under pressure.

 

Enhancing AAV Production Performance And Economics

Enzymatically produced dbDNA offers safer, faster, and more scalable AAV manufacturing by reducing costs, improving full capsid yields, and enabling high‑fidelity, bacteria‑free DNA production.

 

Speeding Up Safety: An Evaluation Of Mycoplasma Technology

Rapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering sensitive contamination detection across diverse matrices.

FEATURED EDITORIAL

How CDMOs Are Accelerating RNA Therapeutics From Lab To Clinic

Praise to the RNA innovators, and our innovative service providers. You’ve brought us a long way. Still, that progress hasn’t necessarily made it easier to strategize the outsourcing of specific RNA-based projects. We’ve expanded development programs therapeutically and dialed up nuanced production requirements. So the current question is what will the RNA outsourcing ecosystem look like a few years from now? Here’s some expert analysis.

 

Expanding Global Access Through Voluntary Licensing And Tech Transfer

Turning patented biomedical discoveries into affordable, widely available treatments requires aligned partnerships between innovator pharma and regional generic manufacturers. In this episode of Outsourcing Against the Outbreak, Charles Gore, Executive Director of the Medicines Patent Pool (MPP), breaks down how voluntary licensing models expand access across low- and middle-income markets.

 

How Smart Outsourcing Is Accelerating ATMP Development

Innovation requires new thinking and approaches. It also heightens the need for disciplined execution. With ATMP development – as well as with any program – starting out on a path lined with outsourcing principles may prove your greatest competitive advantage. A discussion from Chief Editor Louis Garguilo.

INDUSTRY INSIGHTS CONTINUED

 

Challenges In Large-Scale AAV And Lentivirus Manufacturing Using dbDNA

Plasmid DNA supply and regulatory concerns constrain large-scale viral vector manufacturing. Examine whether enzymatically generated dbDNA can deliver comparable rAAV and rLV production outcomes.

 

Boosting Plasmid Yield & Integrity

This e. coli platform boosts plasmid DNA yield, preserves ITR integrity, and reduces variability, enabling scalable, cost-effective manufacturing for gene therapy and vaccine applications.

 

Scaling MSC Therapies To GMP: The Variability Challenge

Scaling stem cell therapies hinges on managing biological variability. Learn how automated 3D processing, defined media, and robust analytics drive predictable development.

 

Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up

Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.

 

The Fast Track To Global Expansion: Consistency Across Every Site

Operational consistency across global facilities protects product integrity and supports growth. Standardized processes reduce risk, minimize variability, and strengthen quality across markets.

 

The Hidden Constraint In GMP Operations Decision-Making

Data Friction stalls critical biopharma decisions and inflates manufacturing risks. See five daily workflows impacted by siloed information and how to build a unified data strategy.

 

The Crucial Role Of Apheresis In Cellular Therapies

Focusing on quality, the presenters will discuss the importance of adhering to collection protocols and the real-world effects on treatment outcomes.

 

The Critical Bottleneck In Personalized Cancer Vaccines

Personalized cancer vaccines face a DNA production bottleneck. Synthetic approaches speed timelines, boost consistency, and simplify workflows to deliver individualized therapies faster.

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Enabling Success in Cell & Gene Therapy — October 29 at 11:00 a.m. ET

Explore the technologies, capabilities, and scale-up strategies advancing cell and gene therapy manufacturing. Leading CGT CDMOs will share insights on process development, technology transfer, clinical supply, and commercial readiness, helping sponsors evaluate potential partners and navigate the unique challenges of advanced therapy manufacturing. Learn more.

SOLUTIONS

Comprehensive Manufacturing Solutions Backed By Global Expertise

3D Modeling Of Facilities With Digital Twin Technology

Your All-In AAV, All-The-Time CDMO

Accelerate Your Next In Vivo CAR-T Program

Your CDMO Partner From CMC Development To Commercial Supply

Services For Advancing mRNA-LNPs From Bench To Clinic

Manufacture Where Care Happens

Scalable Platform Innovation And Productivity Gains

Viral Vector Services

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

 

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