Newsletter | December 16, 2025

12.16.25 -- The Top 10 Nations Redrawing The Outsourcing Map

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INDUSTRY INSIGHTS

Model-Driven Genetic Design And Bioprocess Optimization Across Modalities

By integrating AI and mechanistic models into early design, developers can overcome productivity limits and accelerate timelines for complex therapeutic modalities.

Exploring Strategies For Developing Robust AAV Platforms

Delve into the increasing necessity for carefully designed development platforms to deliver cutting-edge AAV therapies efficiently and safely to patients.

The Future Of Gene Therapy Production: Enriching Full Capsids, Reducing Costs

Gain a deeper understanding of full capsid kinetics, how process intensification improves patient safety, and how tech can be harnessed for scalable gene therapy production.

FEATURED EDITORIAL

The Top 10 Nations Redrawing The Outsourcing Map

The days are gone when your outsourcing strategy could be managed with a simple spreadsheet and a focus on cost-per-liter.

To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem

The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.

INDUSTRY INSIGHTS CONTINUED

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Risk To Readiness: Smart CMC Strategy Defines Advanced Therapy Success

Early, phase-appropriate CMC planning is critical for advanced therapy success. Proactively managing regulatory risks and applying Quality by Design principles secures a clear path to market.

Mastering The Journey From Initial Method Transfer To Successful Lot Release

A panel of experts share potential pitfalls and lessons learned from their many years of experience across a wide array of projects in the cell and gene therapy space.

Enhancing The Upstream Performance Of AAV Vector Manufacturing

Unlock the potential of AAV manufacturing by leveraging data-driven insights and the advanced Pro10™ platform to optimize processes, enhance productivity, and drive innovation in cell and gene therapy.

The Key To Viral Vector Success

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

Leveraging The Right RNA Polymerase Enhance Capping Efficiency

By utilizing an engineered co-transcriptional capping RNA Polymerase, researchers can reduce the production of double-stranded RNA byproducts and enhance the functionality of mRNA therapeutics.

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Regulatory Bar Raised For Cell Therapies: Are You Ready?

Since 2024, multiple cell and gene therapy programs faced regulatory delays due to manufacturing deficiencies, highlighting the critical need for robust CMC strategies and inspection-ready operations.

Why Fill/Finish Operations Make Or Break Viral Vector Therapies

Discover how precision fill/finish processes ensure the safety, sterility, and success of cutting-edge viral vector therapies as they move from production to patients.

Seamless Transitions From Bench To CGT Applications

Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

Transforming Rare Disease Drug Development For A Faster Cure

This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

4 Things To Consider In Pharmaceutical Labeling

Pharmaceutical labeling demands precision. Examine key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options.

Biotech Plant Scale-Up Support Summary

Learn how a biotech company, facing a tight timeline and budget, scaled up its production from the lab to a full commercial site using a strategic operational readiness approach.

Versatile Manufacturing Platform For CGT And Oncolytic Virus Production

See how the iCELLis500+ fixed-bed bioreactor supports the scalable manufacturing of both AAV and oncolytic virus therapies, detailing successful process development and scale-up strategies.

SOLUTIONS

Partnering With Leading Innovator TrakCel To Support CGTs

Our combined offering aims to increase speed-to-therapy by increasing connectivity between providers and hub patient services, enabling seamless care coordination and patient engagement.

Optimize Your RNA-LNP Delivery With Ionizable Lipids

Whether you are advancing RNA-based therapeutics or exploring next-generation nanomedicine, understanding the properties of ionizable lipids is crucial to unlocking the full potential of LNP delivery.

Biosimilar Development: Early-Stage Characterization To QC Release

We provide a complete range of bioanalytical solutions, including method development, validation and transfer; PK and PD Bioanalysis, ELISA and multiplex assays, bioassays, and immunogenicity testing.

Streamlining CRISPR-Cas9 Gene Editing With Ready-To-Use Solution

LipidBrick® Cell Ready enables efficient CRISPR delivery for TCR knockout in T cells, improving viability and expansion over electroporation, with optimized RNA ratios and liposome volumes.

A Concept-To-Commercial Gene Therapy CDMO

The Curator™ adherent platform has been used to manufacture more than 450 Phase 1 and 2 clinical batches, spanning over 17 years and covering a variety of serotypes and indications.

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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