Technology Transfer And The Need For Digital Transformation

Technology transfer plays a pivotal role in bridging the gap between development and manufacturing in the pharmaceutical industry. Defined by ICH Q10 as the transfer of product and process knowledge, it ensures that production meets quality standards while maintaining compliance. However, many companies face challenges with the “digital data gap” that emerges during the transition from early R&D through to commercialization. This gap often stems from relying on spreadsheets and paper records, hindering efficient knowledge transfer and posing compliance risks.

To mitigate these issues, companies are adopting cloud-based data management platforms that act as centralized libraries, capturing critical product data, and ensuring full traceability. These platforms eliminate the risk of data loss during transfer, even as personnel or partners change. With greater visibility into product and process data, companies can better manage supply chain operations and ensure seamless collaboration across teams, sites, and external partners.

By addressing the digital data gap early in development, businesses reduce risks, lower production costs, and accelerate time-to-market, positioning themselves for successful product launches in a highly competitive landscape.