Newsletter | May 12, 2026

05.12.26 -- C> CDMOs: On The Path To $75 Billion In Services?

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Outsourced Pharma Capabilities Update

This online event series connects biopharma companies with CDMOs to explore capabilities across biologics production, HPAPI manufacturing, and drug–device combination development. Through concise presentations, CDMOs showcase expertise in development, scale-up, containment, and GMP manufacturing. Attendees gain insights into technologies, regulatory expectations, and partnership models, while engaging directly with providers to evaluate outsourcing options and identify the best-fit partners for advancing and commercializing complex therapies. Click to learn more.

INDUSTRY INSIGHTS

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.

Eliminating Barriers To In Vivo And Ex Vivo CAR-T Delivery

Assimilate how lentiviral vector processes evolve for in vivo and ex vivo CAR‑T—covering yield, purity, scalability, and shifting regulatory demands for safe, consistent systemic delivery.

10 Questions To Ask When Choosing A Cell Therapy CDMO

A strategic framework outlines ten critical questions to evaluate a manufacturing partner’s reliability, expertise, performance, and operational rigor to ensure successful, scalable cell‑therapy development.

FEATURED EDITORIAL

Cell And Gene Therapy CDMOs: On The Path To $75 Billion In Services?

Cell and gene therapy (CGT) developers – and thus their service providers – have had their share of ups and downs. But what do the promise and uneven realities of these therapies add up to in the development and manufacturing outsourcing sector? According to a Towards Healthcare report, despite the bumps in the road, in 2025 the global CGT CDMO market grew to $8.2 billion. What of future predictions? Here's a detailed analysis.

From Biology Grad To Manufacturing Guru

Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT

Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.

INDUSTRY INSIGHTS CONTINUED

The Slow Drift Toward Variability And The Case For Standardization

Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.

Translating Massive Data Into Therapeutic Momentum

New advances in chemomics, proteome mapping, and modern synthetic methods are redefining how quickly and precisely discovery teams can move from raw data to meaningful clinical momentum.

12.5x Titer Boost Accelerates CAR-T Program To IND Filing

Plasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.

Robotics, ML For Process Intensification

By integrating perfusion into upstream manufacturing, see how this approach has achieved up to a fivefold increase in productivity, delivering titers that significantly exceed current industry benchmarks.

How AI-Enabled Validation Technologies Enable The Predictive Plant

Discover how AI-enabled digital validation shifts manufacturers from reactive compliance to predictive intelligence, connecting validation, asset, and quality data to accelerate digital maturity.

Modern Lentiviral Platforms For Scalable Cell Therapy

A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

Viral Vectors: The Backbone Of Cell And Gene Therapy

Viral vectors are the indispensable backbone of genetic medicine. Uncover the fundamental trade-offs and manufacturing strategies for large-scale production of AAV and lentiviral delivery systems.

Optimized Transient Transfection Platform: AAV Program From Gene To GMP

Achieve faster AAV gene therapy progress by adopting a unified platform for manufacturing. Accelerate your program to GMP readiness with up to 9x higher titers and robust, high-quality full capsid yields.

Accelerating Gene Therapy Development For NEDAMSS

Review how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

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

Browse 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.

SOLUTIONS

End‑To‑End Cell & Gene Therapy Solutions

Advancing Gene Editing With Circular DNA

Variability Reduction Program (VRP)

Your CDMO Partner From CMC Development To Commercial Supply

Innovative RNA Manufacturing: Breaking Barriers With Mutant T7 Polymerase

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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