Newsletter | January 5, 2026

01.05.26 -- CGT Industrialization Starts With CDMO Alignment

FOCUS ON OUTSOURCING

CGT Industrialization Starts With CDMO Alignment

Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.

3 Key Bottlenecks In Cell Therapy Supply Chains

Ensure your cell therapy program is prepared for the future by learning how to effectively navigate sourcing, logistics, and manufacturing challenges with confidence.

Choosing The Right CDMO Partner For Your Biopharma Molecule

Selecting the right CDMO is critical for biopharma success. The ideal partner offers end-to-end capabilities, scientific expertise, quality culture, agility, and transparent collaboration from concept to commercialization.

Development Of A Universal, GMP-Ready, Clonal HEK293 Cell Line

When manufacturing adeno-associated virus, lenti- and adenoviral vectors, see how this HEK293 cell line is optimized for suspension culture and viral vector production, which can significantly reduce costs.

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

Learn 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.

Critical Path For Gene Therapy: AAV Analytical Lifecycle Considerations

Explore considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Review validation challenges and paths for maturation of analytics.

Formulation Development For Therapeutic Oligonucleotides

Discover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.

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.

ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

OUTSOURCING SOLUTIONS

Virotherapy Manufacturing - Recipharm Advanced Bio

Delivering LVV Material In An Accelerated Timeline - AGC Biologics

Proven Expertise And Customized End-To-End Solutions For Your Products - IDT Biologika

Comprehensive Laboratory Testing For Gene Therapies - Labcorp Cell and Gene Therapy Solutions

Gene Therapy Manufacturing Support Made To Optimize Yield, Quality - Ascend & ABL Inc.

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