[YSI News] Lonza Cocoon® FDA AMT Officially granted 🏅

영사이언스
2026-02-10

Lonza’s personalized cell therapy automated manufacturing platform, Cocoon®, has received the Advanced Manufacturing Technologies (AMT) Designation from the U.S. FDA’s Center for Biologics Evaluation and Research (CBER).

Lonza announced on December 11, 2025, that the Cocoon platform had been granted AMT Designation.
The FDA’s AMT Designation Program is designed to promote the adoption of innovative manufacturing technologies that can enhance product quality, strengthen supply reliability, and improve manufacturing efficiency.

This designation represents official recognition of the Cocoon platform’s capability to effectively support GMP-compliant manufacturing processes. In addition, the use of the Cocoon platform in cell therapy development is expected to enable more streamlined and efficient regulatory review, potentially accelerating overall development timelines—from process development through clinical studies and commercialization.

 

For more information about Lonza’s Cocoon® platform, please contact Young Science Co., Ltd.