Newsletter | January 26, 2026

01.26.26 -- Deploying A Vendor Life Cycle Oversight Model

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Navigating Next-Generation Quality Control Strategies For AAV Testing

Explore essential quality control strategies for AAV-based gene therapies, including advanced testing methods and regulatory insights, to ensure safety and efficacy in delivering transformative treatments. Click here to learn more!

FOCUS ON OUTSOURCING

Deploying A Vendor Life Cycle Oversight Model

In this practical guide for adding oversight, based on a hierarchy of metrics, optimize quality agreements to transform them into living, metrics-driven control instruments for your operation.

FDA's Regenerative Medicine Advanced Therapy (RMAT) Program

RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

Revolutionizing LVV Manufacturing For In Vivo And Ex Vivo CAR-T Therapies

Demand for lentiviral vector manufacturing has increased. Explore how scalable, cost-effective, and high-quality LVV manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

The Most Important New Technology Platforms Being Developed Today

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

Challenges In LVV Purification And Quantitation

Hear about how this company is overcoming purification challenges and advancing scalable, GMP-ready lentiviral vector manufacturing for gene and cell therapies.

Tech Transfer: 7 Unique Challenges For Advanced Therapeutics

Ensure the success of your tech transfer by addressing these key challenges and optimizing your processes for seamless scalability and compliance.

Critical Steps To Optimize Viral Vector Manufacturing With CDMOs

To develop a fruitful viral vector manufacturing process and a mutually beneficial relationship between sponsor and CDMO, learn to balance cost, quality, and timeline via transparent communication.

Viral Vectors: The Backbone Of Cell And Gene Therapy

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

Powering Cell Therapy Access: Louisville, KY's Unique Position

Discover why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

Analytical Approach For Bispecific Antibody Quality Study

Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.

From Discovery To Commercialization, The Right Partnerships Are Key

Use this guide to select the right CDMO partner for your pharmaceutical project to navigate the evolving drug development landscape and ensure successful outcomes.

Addressing Challenges And De-Risking Clinical Oncology Development

See why collaboration and innovation are key to overcoming challenges and bringing life-changing cell and gene therapies to those in need.

From Knowledge Management To Learning Empowerment: Talent Development

Observe how to transform biopharma learning with a human-centered, AI-enhanced ecosystem that personalizes development, fosters engagement, and aligns training with real-world impact.

OUTSOURCING SOLUTIONS

Optimizing CGT With Lean Principles - ElevateBio

Capacity Update: Cell & Gene Therapy - Kincell Bio

Accelerated LVV Manufacturing Enabled By Platform Excellence - SK pharmteco

Capacity Update: Cell & Gene Therapy - Andelyn Biosciences

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