AAS-Enabled Digital Data Exchange in Pharmaceutical Supply Chains: A Design Science Approach to Eliminating Manual Batch Data Handoffs Between CDMOs and Drug Product Manufacturers

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1. 

   PREreview

   Sep 9, 2026

   This Zenodo record is a permanently preserved version of a Structured PREreview. You can view the complete PREreview at https://prereview.org/reviews/22674732.

   Does the introduction explain the objective of the research presented in the preprint? Yes The introduction clearly identifies the problem of manual batch-data handoffs between CDMOs and drug product manufacturers and explains the objective of developing and evaluating an AAS-based approach for automated, machine-to-machine data exchange. It also connects the objective to improving data integrity, reducing manual transcription, and supporting GxP compliance.

   Are the methods well-suited for this research? I don't know

   This Zenodo record is a permanently preserved version of a Structured PREreview. You can view the complete PREreview at https://prereview.org/reviews/22674732.

   Does the introduction explain the objective of the research presented in the preprint? Yes The introduction clearly identifies the problem of manual batch-data handoffs between CDMOs and drug product manufacturers and explains the objective of developing and evaluating an AAS-based approach for automated, machine-to-machine data exchange. It also connects the objective to improving data integrity, reducing manual transcription, and supporting GxP compliance.

   Are the methods well-suited for this research? I don't know

   Are the conclusions supported by the data? I don't know

   Are the data presentations, including visualizations, well-suited to represent the data? Somewhat appropriate and clear The figures and tables generally support understanding of the proposed architecture, data-exchange workflow, and evaluation results. However, additional presentation of quantitative or production-representative validation results would strengthen interpretation of the system's performance and applicability in regulated pharmaceutical environments

   How clearly do the authors discuss, explain, and interpret their findings and potential next steps for the research? Somewhat clearly The authors provide a generally clear discussion of the findings and their potential implications for pharmaceutical data exchange. They also identify areas for further development. Additional discussion of validation in production-representative GxP environments, including operational controls and implementation challenges, would further strengthen the proposed next steps.

   Is the preprint likely to advance academic knowledge? Somewhat likely The paper contributes a concrete application of Asset Administration Shell (AAS)-enabled digital exchange to pharmaceutical batch-data handoffs, connecting it with data integrity, ALCOA+, and regulated pharmaceutical workflows. That gives it a potentially useful contribution.

   Would it benefit from language editing? No The manuscript is generally well written, with clear technical language and terminology appropriate for the subject. Minor stylistic improvements may be possible, but they do not significantly affect comprehension of the research objectives, methods, results, or discussion.

   Would you recommend this preprint to others? Yes, but it needs to be improved The preprint presents a promising approach to improving digital data exchange in pharmaceutical environments. However, the work would benefit from further evaluation in a production-representative GxP environment. In particular, the authors could strengthen the discussion of computerized system validation/assurance, audit-trail controls, user access and security, change and configuration management, and maintenance of data integrity throughout the data lifecycle. Additional evidence demonstrating how the proposed approach performs under actual regulated workflows would strengthen its practical applicability and compliance-related conclusions.

   Is it ready for attention from an editor, publisher or broader audience? Yes, after minor changes The manuscript would benefit from minor clarification of how the proposed approach would translate to regulated GxP environments. In particular, the discussion could more explicitly address computerized system validation/assurance, audit-trail and access controls, change and configuration management, and maintenance of data integrity throughout the data lifecycle. Clarifying these practical implementation considerations would strengthen the manuscript for a pharmaceutical audience.

   Competing interests

   The author declares that they have no competing interests.

   Use of Artificial Intelligence (AI)

   The author declares that they used generative AI to come up with new ideas for their review.

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2. Version published to 10.2139/ssrn.6807098

   Jan 1, 2026