We help pharma and biotech companies securely optimize data flow through extended value chain networks.
In a conservative and highly regulated industry with famously long product development cycles, the pandemic has shown the need for dramatically increasing operational flexibility and reducing time to market.
A vital requirement for accelerating the commercialization of new medicines is the transfer of knowledge about a product across all lifecycle phases.
With product and process data predominantly stored across siloed systems and paper-based documents, information is difficult to maintain and share with stakeholders across extended, global value chains.
Establishing a continuous product and process information flow from discovery, clinical and commercial development through internal or external manufacturing can enable efficient and effective technology transfer and scale-up, unlocking significant timeline, cost, and profitability improvements.
We helped a leading pharmaceutical company speed time to trial and patent approval, scaling their portfolio by over 300% with greater compliance.
Reduce tech transfer redundancies and human error to improve efficiencies and decrease scale-up time
Transfer of knowledge about materials, process, control strategy, and validation between drug discovery, development and manufacturing, or between sites must be performed in a methodical manner, with appropriate documentation.
With a digital technology transfer solution, companies can map the ISA 88/95/99 models and data structures across the network, and establish change management, data governance and exchange mechanisms.
Continuous flow of information and real-time insights across the value chain eliminate the need for manual technology transfer acts.
Digital technology transfer encompasses:
- Digital Control Strategy
- Product, Process and Equipment Data
- General Recipe and Transformation for Site-Specific Variations
- Process & Operations Management and Planning
- Digital Work Instructions and Augmented Reality
- Enterprise Change Management and Synchronization
- Electronic Batch Record Management
- Certificate of Analysis Submissions
How we help companies save time and money with efficient technology transfer
Plan & Collaborate
Define process, operations, equipment classes, critical process parameters (CPP), and document data constructs
Map datasets, security access controls, and transfer events between trading partners
Transfer relevant data based on defined events
Apply change control on inbound data
Map internal Digital Knowledge Management system and other solutions (ELN, LIMS, RIMS, etc.) to ingest inbound data
Propagate data to execution systems (ERP/MES) and execute changes in Digital Knowledge Management
Send instructions to the shop floor
Digital tech transfer reduces time to market by an average of 2 years for new pharma and biotech products, and the benefits go beyond cycle time.
Increased labor efficiency of development, manufacturing, quality, and regulatory resources
Improved speed to clinical trials and market authorizations (variations or flavors)
Reduced overall cost of internal and external transfers to manufacturing
Increased speed and efficiency of process validation
Reduced latency of facility, line and equipment provisioning and start-up
Improved batch quality and reduced scrap and waste
Improved speed of regulatory submission and approvals
Improved closed loop quality by design from development to manufacturing and regulatory
Improved traceability into batch genealogy (right country, right product)
We helped a leading pharmaceutical company enhance technology transfer by implementing digital knowledge management for small and large molecule substances, advanced biologics, targeted drug delivery devices and combination products.
Phase 1. Our client’s goal was to get new substances ready for clinical trial and commercialization using contract development and manufacturing organizations (CDMOs) to reduce time to market and cost.
They were experiencing collaboration challenges and inefficiencies with the CDMOs due to difficulties exchanging product requirements and critical formulation data, which was stored in paper-based documents and siloed systems. They realized that without the ability to easily and securely share all their materials and process data for how the product should be produced, they would not be able to get the targeted time and cost benefits.
We worked with our client to implement a digital knowledge management solution, creating a unified repository for recipes, variations, market requirements by region and clear traceability to previous patents.
Our work made it possible to capture and manage knowledge digitally, which improves collaboration internally and externally across the value chain, enhancing technology transfer and speed to trial and patent approval.
Phase 2. Capitalizing on the momentum of digital knowledge management in biologics, we then shifted focus to enabling the same capability for their drug delivery devices and combination products divisions. Because the company was first and foremost a medicines company, established practices were rooted in drug development and we had to adapt and expand them to incorporate discrete device product development management. We worked with our client to implement a solution that manages requirements, product data, CAD data, and risk under change control.
We tailored our approach to encompass not only establishing the right systems, but also education and shifting mindsets to align with leading practices in medical device development.
Phase 3. We are now working with our client to build additional digital mechanisms beyond digital knowledge management to further streamline technology transfer and scale up. A technology transfer brokerage is being established to map ISA 88/95/99 models and data structures across the extended network and also publish standardized data to internal and partner downstream systems such as ERP and MES. This improves change propagation across sites and systems enabling more efficient feedback and collaboration.
Together, we enabled:
- Effective collaboration across an extended manufacturing network
- Streamlined sourcing
- Reduced manual effort and risk
- Accelerated speed to clinical trials
- Faster development in molecule pipeline
- Drug quality management
- Data-driven decisions on product performance
Set the Bar in Your Industry
With decades of product development and manufacturing expertise in pharma and biotech, Kalypso and Rockwell can help drive the requirements for people, processes, technology, data and security to develop the tools and architecture that enable a continuous digital thread for technology transfer and scale up.