Newsletter | August 11, 2026

08.11.26 -- Unlocking Global Growth Through Strategic CDMO Partnerships

INDUSTRY INSIGHTS

Best Practices For Building A Multi-Product Manufacturing

Multi-product ATMP facilities need integrated teams, flexible design, and strategic HVAC to ensure scalability, contamination control, cost efficiency, and reliable long-term performance.

A Scientist's Perspective On Advancing AAV Producer Cell Lines

Ten years of AAV producer cell line development distilled into one scientist's account, including a pivotal platform pivot. Read to understand what gene therapy manufacturing actually takes.

Consistency Engineered For Animal‑Free Bioprocessing

Animal‑free soy‑based materials provide consistent molecular weight profiles, stable mineral levels, and controlled manufacturing to ensure reliable, reproducible bioprocessing performance.

FEATURED EDITORIAL

Unlocking Global Growth Through Strategic CDMO Partnerships

Asset development and outsourcing strategies can be intriguing, and full of global connections. Those attributes surface immediately in a conversation with Hyung Heon Kim, Chief Executive Officer and President, MetaVia, a Cambridge, Mass.-based biotech. The company reformed recently, but has roots back to 90 years of South Korean pharma history. Tracing the CDMO relationship MetaVia has is also part of the organization’s history. “Ours is a fun journey to tell,” says Kim. Fun, informative, and enlightening.

The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable

In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

AI, Data, And The New CDMO Commercial Model

The distance between external API producers and fill-finish experts, and the commercial apparatus of their pharma customers, has lessened. Commercial evidence now starts its derivation as innovation becomes tangible material, set processes, and then product creation … at external development and manufacturing partners. Jon Williams, CEO, Lumanity, says there's a shift toward integrating development strategy and commercial decision-making earlier in the lifecycle.

INDUSTRY INSIGHTS CONTINUED

CAR-T Has A Geography Problem

Cellular immunotherapies deliver strong clinical results, but centralized manufacturing and complex logistics limit access. Regional, standardized production can expand global patient access.

DNA Quality As A Manufacturing Variable: What Sponsors Need To Know

Traditional plasmid DNA manufacturing introduces biological impurities and structural variability that lower viral titers. Transitioning to cell-free synthetic DNA platforms ensures sequence fidelity.

The Difficulties Of Working With Multiple Siloed Partners

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Characterization Of Cellular Starting Material

Watch to gain valuable insights into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products.

Five Key Factors For Sustained Post‑Launch Success

From payer negotiations and formulary expansion to real-time uptake analytics and global distribution, post-launch success depends on a commercialization partner that adapts as market conditions shift.

Evaluation Of Synthetic DNA As An Alternative To Plasmid DNA

Synthetic DNA replaces plasmids for AAV production, cutting contaminants and variability and improving reproducibility and scalability from research to manufacturing.

From LAL To rFC: The Evolution Of Endotoxin Testing

Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.

Unlocking The Economics Of AAV Gene Therapy

Optimizing DNA inputs is key to scaling AAV therapies; cell-free enzymatic methods can cut costs up to 22%, saving millions annually at commercial scale.

Towards A Universal LNP Platform For Multiplex Engineering

Multiplex engineering of T cells for solid tumors requires precise delivery. Emerging LNP approaches enable co-delivery of RNA and DNA, offering a safer, more scalable path beyond viral vectors.

AAV Capsid Analysis With Single Particle Mass Photometry

Accurate AAV capsid ratios are critical to gene therapy efficacy. See how mass photometry delivers faster, lower-cost E/F analysis with single-particle resolution.

SOLUTIONS

Accelerating Cell Therapy: Pre-IND To Commercial Supply

Accelerated Delivery Of Manufacturing Capacity

Minimizing Particulate Risk

Advancing Analytics For Modern Biotherapeutics

Rapid Analytics And Next Generation Sequencing

Plasmid DNA Platform

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.

Connect With Outsourced Pharma: