Newsletter | December 8, 2025

12.08.25 -- The Future Of Biotech Outsourcing: Essential Skills For Program Managers

FOCUS ON OUTSOURCING

The Future Of Biotech Outsourcing: Essential Skills For Program Managers

The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.

The Difficulties Of Working With Multiple Siloed Partners

By partnering with a single supplier that manages the entire manufacturing value chain, companies can minimize risk, enhance operational flexibility, streamline processes, and accelerate their time to market.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

What Are The Keys To Making Rare Disease Drug Development Sustainable?

This roundtable weaves together diverse perspectives from industry leaders, researchers, and patient advocates, offering a multifaceted look at what it will take to create a path forward in rare disease drug development.

A Strategic Enabler For Scaling Gene Therapies

Platform-based manufacturing uses standardized, pre-qualified workflows and analytics that reduce variability, simplify regulatory submissions, and accelerate the path to commercial success.

Nitrosamine Testing: How To Ensure Regulatory Compliance, Product Safety

Explore what nitrosamines are, why testing matters, and how we're able to deliver high-confidence solutions through advanced science and industry-leading expertise.

Efficient Mammalian Cell Engineering For Difficult Protein Expression In 4-6 Weeks

By leveraging cells equipped with an existing TARGATT™ landing pad, we demonstrate how inducible expression can be efficiently achieved within just 4-6 weeks after donor plasmid creation.

CDNPs Enable T Cell Expansion For Scalable CAR-T Manufacturing

Adopt next-generation, physiologic T cell activation strategies to enable faster, more consistent, and scalable CAR-T manufacturing that improves expansion, persistence, and patient access.

Advancing Treatments For Pediatric Patients With Rare Diseases

Advancing cell and gene therapies for rare pediatric diseases requires overcoming unique challenges in trial design, patient access, and long-term follow-up.

Predictive Features Of Apheresis In Gamma Delta T Cell Therapy

Improved iPBMC manufacturing boosts TIL therapy reliability, safety, and affordability through donor screening, process refinements, and performance-based cell selection.

Built For Speed: How To Deliver Without Compromise

Ensure fast, reliable, temperature-controlled logistics with a global infrastructure designed to protect critical biologic materials and keep development programs running smoothly and on schedule.

OUTSOURCING SOLUTIONS

AAV Production: Your AAV CDMO Partner, Every Batch, Every Milestone - MilliporeSigma

Your CDMO Partner From CMC Development To Commercial Supply - Kincell Bio

Capacity Update October 2025: Cell & Gene Therapy - Ascend & ABL Inc.

Advancing Innovative Plasmid DNA Manufacturing Solutions For CGT - Aldevron

Leveraging A Leading Global CMDO - Recipharm Advanced Bio

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