Comment from Pearl BioSystem SAS
AnonymousSupportBusiness
Summary: Pearl BioSystem SAS, a biotechnology company, supports the draft guidance and proposes specific ways to incorporate their matrix-free 3D cell culture platform (in perlo™) into the regulatory framework. They advocate for a staged validation pathway for small and medium-sized enterprises and request the inclusion of specific contexts of use for 3D spheroid platforms in liver toxicology.
Pearl BioSystem SAS respectfully submits the attached formal public comment regarding the FDA draft guidance “General Considerations for the Use of New Approach Methodologies in Drug Development” (Docket No. FDA-2025-D-6131).
The attached document presents recommendations concerning matrix-free 3D cell culture systems, proposed Contexts of Use (COU), staged validation pathways for SMEs, and the deployment of the in perlo platform as a human-relevant New Approach Methodology (NAM).
Submitted by:
Pearl BioSystem SAS
Strasbourg, France
www.pearlbiosystem.com