A leading US investor required a rigorous, independent assessment of a Taiwanese innovator developing a next-generation automated cell mass production system. The goal was to validate the platform’s readiness for the US and European markets before committing to a high-stakes investment and distribution deal.
DIAMANTE conducted an independent due diligence assessment of an automated cell mass production platform, commissioned to support informed decisionmaking related to a potential commercial transaction. The engagement included a comprehensive review of the platform’s technological, operational, and scientific foundations, along with a threeday site visit to multiple facilities. During this visit, DIAMANTE evaluated live demonstrations of the system and analyzed documentation related to design inputs and outputs, process validation, automation capabilities, usability, cybersecurity, scalability, and environmental impact. The first phase of the work focused on verifying the scientific and technological robustness of cell manufacturing technology, to be completed in a sixweek period.
The second phase of the due diligence centered on regulatory evaluation, particularly a detailed gap analysis between regulatory requirements in Taiwan and those of the USA and Europe. DIAMANTE assessed compliance with documentation, quality systems, and potential regulatory risks associated with international deployment of the platform. Preliminary findings identified both strengths and areas requiring further development to meet global standards. The full due diligence was structured to be completed within ten weeks from the start of the engagement, with all conclusions based on information available at the time and subject to further refinement as additional data becomes accessible.