The goal of technology transfer is defined in ICH Q10 as “[the transfer of] product and process knowledge between development and manufacturing and within manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.”
Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. The key determinant to achieving success is the exchange of accurate, compliant data in relevant time.
The Need for Digital Transformation
The Digital Data Gap
Product and process knowledge and various data accumulate in early R&D, development, commercial manufacturing and during clinical trials. While lab research and some product characterization data may be captured digitally, there is often a “digital data gap” that develops (and persists) after product candidate selection and prior to commercial manufacturing. This is driven by the reliance on spreadsheets and paper records prior to the adoption of digital systems such as MES, EBR and historians in a mature manufacturing IT landscape. Effective technology transfer needs to bridge this gap in order to accelerate commercialization and meet production COGS targets and the increasing demands for data integrity and transparency throughout the supply chain. Forward-looking companies are deploying cloud-based, Part 11-compliant, centralized data hubs as their persistent knowledge “libraries” for process, product and patient data. These collaborative data platforms even capture relevant documents and notes and provide a full audit trail of changes to specifications and target control limits. This approach eliminates the risks associated with the “transfer” of technology – as the data remains persistent and available even as staff, partners – and facilities – may change.
Supply Chain Visibility
With the near universal reliance on outsourcing development and manufacturing operations, compliance risks are increasing along with the traditional business risks. The FDA requires evidence that processes – and partners – are being appropriately managed regardless of the actual location of production. The SEC has started to review the sufficiency of company disclosures related to their risks of outsourcing. Movement of product and process knowledge from paper records, spreadsheets and digital systems such as LIMS, EBR, MES and historians across R&D teams during development through various phases of clinical and commercial manufacturing operations and/or from one company to another requires a well-structured data management plan. Planning is required in order to control data access and connectivity capabilities across teams, sites and partners to seamlessly link disparate data systems in a single, validated space where organizations can quickly transition from disruptive, risk-prone, and time-consuming data collation and ad hoc regulatory reporting to automated knowledge management and real-time reporting. Those companies who can leverage digital knowledge platforms retain persistent transparency to their data enabling a more rapid production startup and lower costs.
Maximizing Valuations and ROI
Better data systems are not just returning eye-popping ROI to biopharma companies of all stages, they are helping maximize enterprise valuations upon exit. The termination of Fresenius’ acquisition of Akorn demonstrated that regulatory approval – and even a commercial manufacturing operation – are no longer sufficient to guarantee liquidity events. Acquirers and their advisors are scrutinizing the data sets of their targets to ensure that each high-value revenue stream (drug product) has an inscrutable, high integrity, historical data set upon which to rely. Best practices dictate that companies address the digital data gap as early as possible in their product and process development operations. Adopting scalable, compliant digital tools early will ease the burden and liability of attempting a massive data migration at a later time. A single source of data truth that provides ready access to development, batch, specifications and limits data and enables rapid analytics will deliver tangible benefits to the business while minimizing enterprise risks.
Skyland PIMS® Transforms Manufacturing Process Knowledge Across the Supply Chain
Skyland PIMS® is a cloud-based, easily deployed product and process data management platform purpose-built for life science manufacturing and sponsor – CDMO/CMO collaboration. It provides the end-to-end product life cycle data transparency and knowledge sharing critical to driving effective technology transfer within organizations and across external CDMO/CMO networks. Documented PIMS™ customer benefits include:
- Single Source of Data Truth – PIMS™ provides a single “library” to manage product and process specifications from R&D through clinical and commercialization phases of pharma/biopharma development. It combines integrated workflows to ensure critical data is captured and validated at every stage with notes, attachments and links to supporting documents, all in context and accessible to your entire team. The Data Cascade™ feature means that data is queried or entered once, and it will flow through to PIMS’ charting and analytical functions.
- Sponsor – CDMO/CMO Collaboration Workspace – PIMS™ bridges the information gap between internal and external teams and sites throughout all phases of development. By providing a common and persistent library of product and process data, PIMS™ speeds the scale up and onboarding process and provides seamless operational transparency thereby reducing costs and enabling compliance for the CDMO/CMO and sponsor.
- Specification Change Management – PIMS™ provides a complete change history with a full audit trail for specification and target control limits, seamlessly capturing authorship, timestamp and rationale at every stage of the product life cycle. This delivers an unprecedented capability for historical technology transfer analysis, enabling commercialization teams, for example, to quickly identify and understand obsolete product specifications.
- Process and Supply Chain Robustness – Licensed by product (with no upcharge for the number of users or sponsors or CDMOs/CMOs), PIMS™ delivers the visibility needed to remain compliant and minimize business and supply chain disruptions.
Learn More About Driving Technology Transfer Digital Transformation Using Skyland PIMS®. Connect with us: skylandanalytics.net or Engage@SkylandAnalytics.net.