11 Dec 2025
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  

Basel, Switzerland, 11 December 2025 – 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. 

Additional Information 

Lonza’s Cocoon® Platform technology is covered by patent and/or patent pending rights owned by the Lonza Group Ltd or its affiliates. All trademarks belong to Lonza Group Ltd. and its affiliates (collectively and individually, “Lonza”), and are registered in the USA, EU and/or CH, or used in common law, or belong to third-party owners and are used for only informational purposes. User assumes all risks of product use and handling. Lonza makes efforts to include accurate and up-to-date information. However, Lonza makes no representations or warranties, express or implied, including as to the accuracy or completeness of information, or the use or handling of these products. Lonza may change the content of this advisory at any time without notice but does not assume any responsibility to update it. The user is responsible for determining if the products supplied by Lonza and the information and recommendations given by Lonza are (i) suitable for intended process or purpose, (ii) are in compliance with environmental, health and safety regulations, and other regulations in the regions and countries where they are purchased, offered for sale, marketed, sold, and used, and (iii) will not infringe any third party's intellectual property rights. The user bears the sole responsibility for determining the existence of any such third-party rights, as well as obtaining any necessary licenses and approvals. For more information regarding legal disclaimers and Lonza’s intellectual property rights: 
www.lonza.com/cocoon
www.lonza.com/legal
www.lonza.com/about-us/strategy/intellectual-property.
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