Newsletter | June 23, 2025

06.23.25 -- Rethinking CGT Biotech Growth & Investment With Audrey Greenberg

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Applying Next Generation Sequencing (NGS) To Accelerate Cell And Gene Therapy Product Development

Explore the transformative power of Next Generation Sequencing (NGS) in accelerating cell and gene therapy product development. This poster highlights innovative applications of NGS in viral vector characterization, quality control, and safety assurance, offering critical insights that enhance product safety and efficacy – access it here.

FOCUS ON OUTSOURCING

Rethinking CGT Biotech Growth & Investment with Audrey Greenberg

On the 100th episode of Cell & Gene: The Podcast, Host, Erin Harris, sits down with Audrey Greenberg, Founder and CEO of AG Capital Advisors. Audrey is the award-winning executive, board director, and strategic advisor with a proven track record of launching, scaling, and successfully exiting multi-billion-dollar ventures.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered TARGATT landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Determining Full-To-Empty Capsid Ratio For rAAVs

Leverage mass photometry to quickly and accurately monitor the full-to-empty ratio of rAAV samples, ensuring consistent product quality and enhanced safety and efficacy in gene therapy applications.

Discovery Through Commercialization: A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

Early-Stage Choices That Shape Cell Therapy Commercial Viability

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Viral Vector Manufacturing: A Case For Adherent Cell Culture

Review the importance of alternative approaches to viral vector production and the benefits of intensified adherent cell culture for improving efficiency, reducing costs, and accelerating development.

4 Key Autologous Manufacturing Challenges (Plus How To Solve Them)

The manufacturing process for autologous therapies is complex and highly customized, requiring well-orchestrated transport, careful planning, and tight control of many discrete and manual processing steps.

Spent Media Analysis To Improve Cell Therapy Manufacturing

Targeted metabolomics-based PAT allows for metabolic profiling of the T-cells throughout the cell therapy manufacturing process through spent media analysis.

How PATs Improve Bioreactor Performance And Inline Monitoring

Accurately monitoring process parameters and bioreactor performance while leveraging process analytical technologies can lead to strong improvements in productivity, quality, and process stability.

Establishing A Versatile Platform For Intensified LVV Manufacturing

Accelerate access to high-quality, cost-effective lentiviral vectors with our intensified TFDF-based manufacturing platform, delivering multi-fold yield improvements and scalable, space-efficient production.

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Webinar: Fixing the Monitoring Model: How a Flexible Resource Supports Trial Success

As clinical trials grow increasingly complex, traditional monitoring models are showing their cracks. Overextended CRAs, inconsistent site engagement, and reactive oversight can lead to delays, data quality issues, and strained site relationships. Join clinical operations experts for a candid conversation about what's not working in today’s trial monitoring—and what could.

OUTSOURCING SOLUTIONS

Comprehensive, Integrated BioServices - Cryoport Systems

Pace Life Sciences Capacity Update April 2025: Analytical Services - Pace Life Sciences

Tissue Adenosine Distribution-Guided Gene Selection - Aliri Bioanalysis

Small Scale Feasibility - Viralgen

Scalable, cGMP-Ready AAV & LV Platform Processes - IDT Biologika

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Explore the evolving role of exosomes and extracellular vesicles (EVs) at the next Cell & Gene Live. Chief Editor Erin Harris moderates a discussion with Capricor’s Linda Marbán and Aegle’s Dr. Gloria Matthews on clinical and commercial advances, including applications in rare and cardiovascular diseases. Gain insights into the future of exosome-based therapies from leaders driving innovation across R&D, manufacturing, and commercialization.

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