Newsletter | August 28, 2025

08.28.25 -- Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

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Meet the Next Evolution of ddPCR Solutions

Introducing Bio-Rad's most advanced Droplet Digital™ PCR (ddPCR™) systems yet — the QX Continuum™ and QX700™ systems series, which set new standards in sensitivity, workflow simplicity, ease of multiplexing, and performance through absolute quantification. Learn More

FOCUS ON MANUFACTURING

Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

Navigating Cell Therapy Process Development

Equip yourself with the knowledge necessary to make well-informed decisions by exploring the main challenges and considerations inherent in cell therapy process development.

Advancements In Gene Therapy Development

Gene therapy is transforming treatment for genetic disorders. With over 30 FDA-approved therapies, gain expert insight into how digital PCR enhances AAV vector precision, safety, and regulatory compliance in development.

The Basics Of Cell Culture: Key Steps In Manufacturing Cell Therapies

Producing viable cell-based therapies is a delicate science. Explore the fundamental culture processes, from initial cell extraction to final patient administration.

Activation Methods To Yield Clinical-Scale Expansion Of Gamma Delta T Cells

Data from the use of two distinct methods to generate billions of gamma delta T cells from peripheral blood mononuclear cells (PBMCs) is compared.

Overcoming Challenges In CGT Development

Explore connector solutions for sterility, chemical compatibility, and ultra-low temperature challenges when setting up a therapeutic process for long-term success.

Enhancing Process Development With Viral Clearance

Streamline mAb purification with confidence. Learn practical considerations for developing processes with advanced mixed-mode chromatography, ensuring superior impurity and viral clearance from the start.

Challenges In Viral Vector Production & Innovative Solutions

Single-use technology is playing a large role in increasing flexibility and reducing contamination risks for the biopharmaceutical industry. Take a deeper look into all of the advantages and challenges.

Development And Optimization Of LNP Formulations

The production of lipid nanoparticles (LNPs) is a process that demands robustness, scalability, and reproducibility. Examine the impact of key operational parameters on the efficacy of LNPs.

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Webinar: Solving Fragmentation: Expert Insights on Future-Proofing the Advanced Therapy Supply Chain

This Cryoport webinar explores how integrated, purpose-built supply chain platforms can overcome the risks and delays of fragmented logistics in cell and gene therapy. Industry leaders share real-world strategies for standardizing collection, cryopreservation, and storage, aligning logistics with manufacturing, and scaling operations globally to improve reliability, accelerate commercialization, and enhance patient outcomes. Click here to learn more.

MANUFACTURING SOLUTIONS

Introducing A New GMP-Grade Endonuclease For VV Manufacturing - Roche CustomBiotech

CHOgro Expression System - Mirus Bio

Invetech Bio-Expo Live 2024: Downstream Bioprocessing - Invetech

Complete Solutions For Every Step Of Pharmaceutical Development - Cytiva

Single-Use Customization Services - Charter Medical

IRO: The New Standard Of CGT Manufacturing - Ori Biotech

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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