Newsletter | January 19, 2026

01.19.26 -- Metrics, Not Audits, Should Lead Vendor Accountability

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Join Cell & Gene's Chief Editor, Erin Harris, for this timely Cell & Gene Live offering an in-depth regulatory outlook with two of the field's most trusted experts, Wilson Bryan, M.D., former director of FDA's Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners. Learn More!

FOCUS ON OUTSOURCING

Metrics, Not Audits, Should Lead Vendor Accountability

Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

Overcoming Challenges For Rare Disease In Pediatrics

Advancing cell and gene therapies for rare pediatric diseases will require innovative trial strategies, early diagnosis, and improved treatment technologies.

Improving Viral Vector Production Through Addressing Complexity

Watch as our CGT experts explore the evolving landscape of viral vector manufacturing, overcoming production bottlenecks, and the strategies necessary to bring life-changing therapies to more patients.

Enhancing Safety And Efficacy Of mRNA-Based Therapeutics

Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.

What's The Greatest Risk For CDMOs Ahead?

Economic volatility, regulatory uncertainty, and capacity constraints pose major risks to CDMOs, threatening growth, profitability, and long-term sustainability in an increasingly competitive global market.

Outsourcing For Beginners: Cell & Gene Therapy Modalities

Unlock the knowledge and strategies you need to navigate the complexities of CGT outsourcing and accelerate the success of your cell and gene therapy projects.

Partnering For Success In Oncolytic Virus Development

Learn how to navigate decision-making at critical steps and find solutions to key challenges in process development and scale-up to expedite oncolytic virus programs.

Blueprint To Modernizing CDMO Manufacturing Operations

Industry 4.0 is revolutionizing CDMOs and CMOs. Find out how AI, IIoT, and automation are driving smarter, faster, and more compliant manufacturing to ensure agility, precision, and innovation.

Part Three: Rapid LVV Titering Determination

Explore how a platform compares data to traditional qPCR, p24 ELISA, and TU assays in measuring both physical and functional titers.

Accelerated LVV Manufacturing Enabled By Platform Excellence

Read how a manufacturing platform enabled the rapid production of lentiviral vector in eight months. Check out this strategy used to balance speed, risk mitigation, and the highest quality standards.

Clinical Apheresis: Unlocking Quality For CAR-T And Cell-Based Therapies

Specialized cell collection services depend on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.

A Scalable Platform To Revolutionize Gene Therapy Manufacturing

Discover how our innovative rAAV production platform can revolutionize your gene therapy pipeline with unparalleled yield, quality, and scalability.

OUTSOURCING SOLUTIONS

Oligonucleotide Discovery And Development - Pace® Life Sciences

Microbial Platform For Protein Expression - Lonza

Biologics Discovery Service: From Target To Preclinical Candidates - ProBio

cGMP Cell Manufacturing - Applied StemCell

Advanced iPSC Workflows: Accelerating Cell Therapy Development - Catalent

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