Newsletter | January 20, 2026

01.20.26 -- 2025 GLP-1 Impacts Tell Us About CDMOs In 2026

SPONSOR

Outsourced Pharma Capabilities Update – Fill/Finish

This event offers short, interactive digital presentations from leading CDMOs showcasing their capabilities, facilities, and available capacity for biopharma development and fill-finish manufacturing. Attendees can explore sterile filling, lyophilization, and packaging technologies, and ask questions live. Open to pharma and biotech professionals, industry consultants, investment firms, and CDMO sponsors seeking manufacturing solutions. Click here to learn more.

INDUSTRY INSIGHTS

Best Practices To Adapt And Improve Quality Control Programs For CGTs

Cell and gene therapies require adaptive and advanced assays for characterization and safety assessments, and assays historically used for biologics must diversify to accommodate them.

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.

Achieving Cell Therapy Success: Reducing Costs To Improve Patient Access

To ensure the commercial success of cell therapies, developers must adopt innovative manufacturing and QC technologies that reduce COGS while enhancing scalability, quality, and clinical outcomes.

FEATURED EDITORIAL

2025 GLP-1 Impacts Tell Us About CDMOs In 2026

When we began covering the nexus between GLP-1 drugs and CDMO capacity, there were two key questions: Could Big Pharma keep up with demand? Would the CDMO market also have capacity to serve the thousands of drug sponsors needing assistance with their non-GLP-1 programs? Those answers in 2025 tell us a lot about our industry heading into 2026.

Strained Manufacturing, Complexity Stymie In Vivo Progress

 Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

INDUSTRY INSIGHTS CONTINUED

New Technology Platforms Being Developed

Emerging technology platforms are transforming drug development, enabling faster discovery, improved scalability, and greater precision across biologics, advanced therapies, and data-driven processes.

Best Practices In The Design Of A Pharmaceutical Manufacturing Facility

A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

Quality Agreements: Defining Governance In CDMO Partnerships

Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.

Optimizing Safety Measures For rAAV Therapies

See common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

Viral Vectors: The Backbone Of Cell And Gene Therapy

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

Key Analytical Considerations For Developing A Clinical AAV Program

Unlike traditional drugs, AAV therapies require extensive characterization and testing, demanding varying degrees of analysis at each stage of development.

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.

Our Analytical And Quality Control Strategy For Your Therapies

A comprehensive Quality Risk Analysis and Control Strategy is built on five key pillars, each playing a vital role in ensuring that every final product meets the highest safety and efficacy standards.

Quality Foundation: Aligning Operations And Quality For Patients

Quality is the foundation of leadership and operations, ensuring collaboration and strategic focus to deliver safe, effective cell therapies without compromising patient safety or regulatory standards.

The Future Of CGT: Phase-Appropriate Plasmid DNA Manufacturing

Effective CGT development depends on phase-appropriate manufacturing. Aligning manufacturing rigor with the clinical phase ensures quality at the right time while reducing costs and accelerating timelines.

SOLUTIONS

cGMP Cell Manufacturing

Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?

Cryopreservation Services From Cryoport Systems

Cryopreservation services improve cell therapy safety, quality, and viability through standardized protocols, global cold-chain integration, and enhanced manufacturing efficiency. 

Small Scale Feasibility

With a simple quote and 10mg of your research-grade transgene plasmid, a small-scale feasibility study, including downstream purification, can be performed.

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market.

AAV Edge System

Uncover a modular tool suite capable of achieving titers up to 6E15 vg/L. Move from transfection to stable cell lines in just 20 weeks using AI-driven optimization and robust host platforms.

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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