Newsletter | July 30, 2025

07.30.25 -- Audit Trail Compliance And What To Look For In Mitigation Software

SPONSOR

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

Audit Trail Compliance And What To Look For In Mitigation Software

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

Decoding AAV: Navigating Critical Quality Attributes And Their Analytics

Ensuring consistent quality in genetic therapies by defining key attributes and using advanced analytical tools.

Removing Analytical Bottlenecks On The Path To Clinical Readiness

Explore how cellular therapy manufacturing is advancing by standardizing and automating analytical methods that enhance IPC and QC efficiency to overcome delays and streamline development.

Cell Culture Media Quality Control Strategies

Cell culture media quality is key for lab success. Learn essential sourcing, storage, and handling strategies to prevent contamination and costly setbacks.

Does My Cleanroom Facility Need A Residue Removal Step?

Explore the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.

REGULATORY & COMPLIANCE SOLUTIONS

Cell Therapy Process Development Made Easy - Cytiva

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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