Lonza's Cocoon Platform Receives Advanced Manufacturing Technologies (AMT) Designation From The U.S. FDA

• FDA granted Lonza’s Cocoon Platform the Advanced Manufacturing Technologies (AMT) Designation
• Designation expected to reduce regulatory uncertainty and promote adoption of Lonza’s Cocoon Platform technology

Lonza today announced that the Cocoon Platform has been granted AMT Designation by the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. This recognition underscores the Cocoon Platform’s ability to support robust, GMP-compliant manufacturing of cell therapies through its functionally closed, automated design.

The Cocoon Platform’s reagent flexibility and open protocol programming architecture allow users to rapidly identify and optimize manufacturing processes while the form factor, remote monitoring, and automation allow for efficient manufacturing scale-up. These factors aim to accelerate the path from process development to patient delivery, while reducing manufacturing costs.

The FDA's AMT Designation program is designed to facilitate the adoption of innovative manufacturing technologies that can enhance drug quality, increase the reliability and efficiency of the supply chain, and address drug shortages. The AMT Designation provides Lonza and its customers with enhanced opportunities for early and frequent communication with the FDA, which could help to expedite the regulatory review process for cellular therapeutic applications that rely on the Cocoon Platform. This opportunity for enhanced communication with the FDA is expected to reduce regulatory uncertainty and support the broader adoption of Cocoon Platform technology across the cell and gene therapy industry.

Adam Bryan, Vice President, Personalized Medicine, Specialized Modalities, Lonza, said: “The AMT Designation is an important step in recognizing the Cocoon Platform as a manufacturing system of choice for automated cell therapy manufacturing, in order to help our customers bring their therapies to patients faster by reducing cost and risk.”

About The Lonza Cocoon Platform
The Lonza Cocoon Platform is an automated and functionally closed cell therapy manufacturing system that is capable of end-to-end cell manufacturing of patient samples from leukopak, peripheral blood mononuclear cells (PBMCs), or purified cells to therapeutic product using a range of GMP cell selection products, cytokines, and media. The Cocoon Platform uses a single-use cassette to automate the cell and gene therapy manufacturing process. Its flexible, customizable, and scalable design empowers developers to streamline IND-enabling activities and accelerate clinical translation of advanced cellular therapeutics.

For more information, visit www.lonza.com/cocoon, www.lonza.com/legal and www.lonza.com/about-us/strategy/intellectual-property.