10.21.25 -- The FDA 483 Heard Round The World

Unlock success in next-generation biologics development with Lonza. In this webinar, our experts share real-world case studies and practical CMC strategies to avoid pitfalls, reduce risk, and keep timelines on track. Learn how smart design, cross-functional collaboration, and CDMO partnerships accelerate progress from early development to first-in-human manufacturing—delivering innovative therapies to patients faster. Register now! Click here to learn more.

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

Ensure the success of your tech transfer by addressing these key challenges and optimizing your processes for seamless scalability and compliance.

Drive the next wave of cell and gene therapy innovation by overcoming operational, funding, and regulatory challenges to deliver life-changing treatments to patients faster.

The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

By refining variables such as starting DNA, reagents, cell density, and media composition, organizations can improve rAAV process efficiency and scalability.

Here, we demonstrate how leveraging cells equipped with an existing TARGATT™ landing pad can efficiently achieve inducible expression within just 4-6 weeks after donor plasmid creation.

Learn how this process development platform for MVA impacts vaccine manufacturing and supports the drug life cycle from process and analytical development through trials and commercialization.

Emerging biotech companies are investing in delivery capabilities to address the needs of various modalities and extra-hepatic delivery. Consider these steps for faster commercial nanomedicine delivery.

Kelly Kral from bluebird bio and Lonza's Anthony Basile share a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.

Review what nitrosamines are, why testing matters, and how we're able to deliver high-confidence solutions through advanced science and industry-leading expertise.

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Meredith Canty of Drug Delivery discusses best practices and tips across a range of topics, including program management, automation, and secondary services, with Charlotte Ward and Ryan Moran.

To ensure the safety of tumor-infiltrating leukocytes (TIL) therapies, it's important to use cGMP-compliant feeder cells confirmed to be non-proliferative through competency testing.

Understand the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.

Standardized, well-characterized plasmids and platform processes can accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

Gain insight into the challenges of sourcing and variability of cellular material and how characterization assays can mitigate the inherent risks of progressing living cells through development.

This study aims to explore the kinetics of capsid formation and impurity profiles over time, offering insights that can inform future process improvements.

This process was created to overcome challenges, such as supply chain bottlenecks, lack of scalability, and variability associated with customer-driven SOPs, analytical testing, and raw materials.

Director of Commercial Development, Serat Ali, describes FDBs' Advanced Therapy capabilities, discusses their global facilities network, and provides a capacity update.

Streamline complex CGT logistics with an integrated platform that connects manufacturers with vital services, providing full visibility and control for a more efficient and successful patient journey.

Xcite™ AAV platform technology is established based on our proprietary suspension HEK293 cell line and plasmid vectors, proven to enhance AAV production.

This approach enables researchers and biopharmaceutical companies to advance their programs more efficiently, from early-stage discovery through clinical trials and into commercial deployment.