Newsletter | September 9, 2025

09.09.25 -- Precigen Secures FDA Approval For PAPZIMEOS And Redefines RRP Treatment

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New Whitepaper: Insights into MSC-Based Therapies

Discover key advancements in MSC-based therapies with insights from Corning's Field Application Scientists. Explore methods for MSC isolation, production considerations, media options, cell expansion technologies, and cGMP manufacturing. Gain valuable learnings from collaborations with academic researchers, biotech, and pharmaceutical companies, featuring real-world case studies. Whether you're scaling for clinical applications or advancing research, this whitepaper provides actionable strategies to optimize MSC production and push the boundaries of therapeutic development.

FOCUS ON MANUFACTURING

Precigen Secures FDA Approval For PAPZIMEOS And Redefines RRP Treatment

Precigen has received FDA approval for PAPZIMEOS, the first therapy for recurrent respiratory papillomatosis, marking a major advance in patient care.

The Truth About End-To-End Manufacturing Automation

Discover how automation, modular design, and real-time analytics are transforming cell and gene therapy manufacturing to unlock scalable, cost-effective production without compromising quality.

Biosafety Testing And Quality Control Requirements For Lentiviral Vectors

Learn more about manufacturing principles of LV vectors as well as testing requirement regulatory considerations with a particular focus on the replication competent virus assay and infectious titer assay.

Rethinking Capital Efficiency In Cell Processing

In cell processing, rigid, single-function equipment can lead to inefficiencies, wasted space, and scheduling conflicts. A versatile approach can help teams do more with less.

Detection Of Rare And Low-Expressing BCMA CAR-T Cells

Discover how precise flow cytometric identification of CAR+ cells across diverse models and workflows enables high specificity, flexibility, and sensitivity—even in rare or low-expression populations.

Quantifying Lentiviral Physical Titer

Streamline lentiviral vector analytics with our direct RT-dPCR method. Achieve precise, reproducible results to accelerate safe, effective gene therapies with enhanced quality control.

Multicolor Immunophenotyping Of Human Tumor Cells

Flow cytometric phenotyping is crucial to enabling precise immune monitoring. Discover how standardized assays with an 8-color cocktail enhance the understanding of tumor immunity and therapeutic impacts.

The Key To Accelerating RNA-LNP Drug Development

Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.

Simpler, Faster, Cheaper Advanced Therapy Manufacturing

Discover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.

Mycoplasma And Sterility Testing: Ensure The Safety And Purity Of Your Product

Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.

Syringe Filtration With Integrated Prefilter Technology: Improving HPLC

In this article we review how particulate removal through filtration effects column life and how to handle difficult to filter samples.

Achieve Higher AAV Productivity With A Next-Generation Transfection Reagent

Learn about a next-generation transfection system that requires 50% less plasmid, decreases transfection reagent consumption, and yields higher AAV productivity to reduce cost per dose.

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Webinar: Advancing Non-Viral Gene Editing: CellShot® PFEP Technology and Proliva™ for Enhanced Post-Electroporation Performance

Join FEMTOBIOMED's webinar to discover how the CellShot® platform is transforming non-viral gene delivery with PFEP™ electroporation and Proliva™ technology. See real-world data proving higher viability, proliferation, and efficiency in CRISPR and TALEN workflows. Gain actionable insights to optimize research and GMP manufacturing. Don't miss this opportunity to overcome gene-editing bottlenecks and accelerate your programs. Click here to learn more.

MANUFACTURING SOLUTIONS

Efficient Production Of MSCs And Exosomes - Terumo BCT

Flex Mixing System - Entegris, Inc.

MicroCNX Nano Series Connectors Assembly Overview - CPC

Single-Use Bioreactors With Vertical-Wheel Technology - PBS Biotech, Inc.

CRISPR From Research To Therapy - Lonza

Cleanroom Technology For Unparalleled Cleanliness and Speed - AES Cleanroom Technology

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Discover how allogeneic NK cell therapies are reshaping cancer immunotherapy! Join Cell & Gene's Erin Harris as she hosts industry leaders for a dynamic discussion on their groundbreaking, complementary approaches. Don’t miss this inside look at the future of cell therapy—Register now for free! This event is supported by ThermoFisher Scientific.

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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