Digital Preservation for the Next Generation of ATMPs: Future-Proofing Today’s Data

Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products, represent some of the most cutting-edge innovations in the pharmaceutical and biotechnology industries. These therapies hold promise for treating diseases that were once considered untreatable. However, the development, approval, and commercialisation of ATMPs involve significant amounts of complex data that must be stored, preserved, and accessed over long periods.

With this in mind, digital archiving and data preservation play a crucial role. Ensuring the long-term availability, safeguarding, and integrity of data is not only a regulatory requirement but also a vital element of operational success. Below, we will look at the importance of digital archiving and preservation in the ATMP sector and why it must be prioritised during the digital transformation of pharmaceutical organisations.

1 – Compliance with Regulatory Requirements

ATMPs are subject to rigorous regulatory scrutiny, given their innovative nature and potential risks. Regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) require detailed documentation at every stage of the product lifecycle—from early research and clinical trials to commercialisation and post-market review.

Digital archiving ensures that all necessary records, including clinical data, trial outcomes, patient information, manufacturing processes, and quality control documentation, are stored securely and can be retrieved easily when required. Data preservation, in turn, ensures that this information remains accessible and usable even decades after its creation, meeting regulatory mandates for long-term record retention.

One example is Regulation (EC) No 1394/2007, which subjects ATMPs to strict traceability requirements, which of course highlights the importance of long-term data retention. The regulation requires manufacturers and healthcare institutions to maintain traceability data for at least 30 years beyond the product’s expiry date. This extended period ensures that both patient safety and product efficacy are closely monitored over time, supporting thorough oversight of ATMPs throughout their lifecycle.

For ATMP developers, maintaining digital archives that align with regulatory requirements such as (EC) No 1394/2007, it helps them avoid costly compliance issues, including fines, delayed approvals, or even product recalls.

2 – Ensuring Data Integrity for Long-Term Studies

Many ATMPs undergo long-term studies, especially during post-market monitoring, to evaluate their safety and efficacy over long periods. If we look at gene therapies as an example, the effects of a single treatment may unfold over several years, which means ongoing data collection and analysis is needed.

Digital preservation ensures that data remains in its original form, protected from degradation, loss, or corruption. This guarantees that researchers, regulatory bodies, and clinicians can rely on accurate historical data when evaluating long-term treatment outcomes or making adjustments to therapy protocols.

3 – Safeguarding Intellectual Property and Research Data

The development of ATMPs often represents years of groundbreaking research and substantial financial investment. The data generated throughout this process (from early-stage research to clinical trials) is invaluable not only for regulatory approval but also for protecting intellectual property (IP).

Digital archiving provides a secure, accessible repository for this sensitive data, ensuring that companies can protect their IP and demonstrate ownership when needed. In the event of patent disputes or intellectual property challenges, having an organised, well-preserved digital archive can be critical for defending proprietary technologies or innovations.

4 – Supporting Collaboration and Knowledge Sharing

The development of ATMPs typically involves collaboration across multiple stakeholders, including academic institutions, pharmaceutical companies, regulatory agencies, and clinical research organisations (CROs). These collaborations generate vast amounts of data, and effective sharing of that data is critical for streamlining research and accelerating time to market.

A well-structured digital archiving and preservation system allows organisations to easily share and access vital information. This not only supports collaboration but also ensures that all parties are working from the same accurate, up-to-date data set.

5 – Enhancing Operational Efficiency

Digital archiving streamlines the process of organising, storing, and retrieving data, making it easier for teams to access what they need, when they need it. By reducing time spent on manual data management tasks, organisations can improve operational efficiency and focus more on the innovative work of developing and delivering life-saving therapies.

Conclusion: Future-Proofing ATMP Development with Digital Archiving

As ATMPs continue to revolutionise medicine, the volume and complexity of data generated during their development will only increase. By prioritising digital archiving and preservation, organisations can ensure that their data is not only secure and accessible but also compliant with regulatory standards and ready to support long-term success.

For any pharmaceutical or biotech company involved in ATMP development, investing in a robust digital archiving and data preservation strategy is important. It not only protects valuable data but also future-proofs the organisation against evolving regulatory demands, technological advancements, and the growing importance of data-driven decision-making in the field of advanced therapies.