Newsletter | July 16, 2025

07.16.25 -- Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN

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With pressure to both accelerate development and prioritize robustness, CGT companies often have limited time for refining manufacturing, analytics, and logistics. Enter the Cell & Gene Therapy Tech Expo: a dynamic slate of industry-leading suppliers showcasing the latest in solutions across Cell Therapy, Gene Therapy, and GMP/Regulatory Compliance via 15-minute interactive presentations. Register for free and make continuous improvement a reality on your path to scalability, cost reduction and, ultimately, enhanced patient access.

FOCUS ON REGULATORY & COMPLIANCE

Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN

By Erin Harris, Editor-In-Chief, Cell & Gene

AviadoBio and Astellas have joined forces to advance an investigational gene therapy designed to treat frontotemporal dementia with progranulin mutations (FTD-GRN), aiming to address a critical unmet need in neurodegenerative disease.

Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing

White Paper | 3P innovation

Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.

Navigating Regulatory Complexity In CGT Development, Commercialization

Article | Cencora

To successfully commercialize cell and gene therapies, understanding evolving US regulatory mandates is key. Consider these strategies to avoid delays and ensure compliance.

Future-Proofing The Material Transfer Process In Your Facility

Webinar | Ecolab Life Sciences

Minimize contamination risks in Grade A/ISO 5 areas. Discover how integrating automated bio-decontamination with manual methods enhances your cell and gene therapy material transfer program.

CMC And Regulatory Considerations For CRISPR Therapies

Article | Synthego Corporation

This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.

Developing A Comprehensive Regulatory Approach For LNP Drugs

Article | Cytiva

The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

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The PDA Regulatory Conference 2025 Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle continues its 34-year tradition of delivering impactful content that supports the development and implementation of effective quality systems across the product lifecycle. This premier pharmaceutical CGMP conference on 08-10 September 2025 in Washington, DC will focus on strategies to manage manufacturing and quality risks while driving operational excellence and sustainable compliance.

REGULATORY & COMPLIANCE SOLUTIONS

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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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