05.20.26 -- Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem

This expert panel breaks down the practical realities of today’s supply chain while forecasting how emerging technologies will redefine quality standards.

Building operational readiness requires early strategic choices. This framework ensures long-term flexibility and compliance from the initial concept phase through final project delivery.

Modern lab equipment is essential to scientific research, but maintaining it is increasingly complex. Discover key challenges and strategies to futureproof your maintenance approach.

CGT regulations are rapidly evolving. With hundreds of therapies in development, scalable automation and smarter systems are essential to meet compliance, reduce complexity, and protect patient lives.

Strengthen your research processes by adopting secure systems, staying current with regulatory standards, and ensuring your team is consistently trained to manage data responsibly and efficiently.

Strategic manufacturing decisions are vital as regulators update quality expectations. Focus on consistency and safety to improve the speed and reliability of your development pipeline.

A holistic approach to CCI shifts focus from end-product testing to built-in quality across the lifecycle. Learn how science- and risk-based strategies can strengthen sterility assurance.

Determining when to initiate IND activities is critical for sponsors. Early engagement allows access to vital regulatory guidance, facilitating a smoother path toward U.S. clinical trials.

Examine these five key factors for advancing targeted in vivo LNP programs, from formulation and targeting strategies to bioanalytical readiness and scalability.

ADC payloads active at nanogram concentrations create serious operator safety risks. What must manufacturers get right to protect operators across every stage of production?

Compare global requirements from major regulatory bodies. Advanced barrier systems help align international standards to maintain sterile integrity and ensure high-quality production.

EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

As biopharma shifts toward personalized and smaller‑batch therapies, modular infrastructure is redefining how facilities are built and scaled to enable faster deployment and greater flexibility.

Industrial AI is changing how operations use data, making insights reliable, scalable, and grounded in a real manufacturing context. Discover how unified IT/OT intelligence enables predictive optimization.

Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

This guide ranks fluorochromes, offers pairing strategies, and provides practical tips for designing high-quality, multiparameter assays with clear population separation in your flow cytometry panels.