We help pharma, biotech and CDMO companies securely optimize data and knowledge 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, scaling drug manufacturing globally and ultimately 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 on glass documents, information is difficult to maintain, reuse and share with stakeholders across extended, global value chains.
Establishing a continuous product and process information flow with robust change control 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 pharma company speed time to trial and patent approval, scaling their portfolio by over 300% with greater compliance.
Shorten scale-up time by eliminating tech transfer redundancies and human error
Transfer of knowledge about materials, process, equipment, 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.
Reliable digital data facilitates data reuse, continuous flow of information and real-time insights across the value chain, improving efficiencies and eliminating the need for manual technology transfer events.
Digital technology transfer encompasses:
- Network Node Management
- Digital Control Strategy
- Secure Product, Process and Equipment Data
- Data Conversion and Mapping
- General Recipe and Transformation for Site-Specific or Market Variations
- Process & Operations Management and Planning
- Digital Work Instructions and Augmented Reality
- Enterprise Change Management and Synchronization
- Electronic Batch Record Management, Publication and Consumption
- Digital Certificate of Analysis Creation and Submission
How We Help Companies Enable 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.
Reduced overall cost of internal and external transfers to manufacturing
Increased labor efficiency of development, manufacturing, quality, and regulatory resources
Improved speed to clinical trials and market authorizations (variations or flavors)
Faster, more efficient process validation
Reduced latency of facility, line and equipment provisioning and start-up
Improved batch quality and reduced scrap and waste
Faster 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 pharma company enhance technology transfer and reduce time to clinical trials 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 initial goal was to dramatically improve the lead optimization phase, by managing the knowledge during the synthesis of lead compounds, identifying new analogs with improved potency, and reducing off target activities. The client had divested their pilot plants and wanted to accelerate getting new compounds ready for clinical trials and commercialization by leveraging CDMOs to reduce time to market, cost, and improve speed to clinical trials.
The client was experiencing knowledge sharing, collaboration challenges and inefficiencies with the CDMOs due to difficulties in exchanging product requirements and critical formulation data, which was stored in paper-based documents and siloed, externally inaccessible systems. They realized that without the ability to easily and securely share relevant materials and process critical quality requirements for how the product should be produced, they would not be able to achieve the targeted time and cost benefits of partnering with CMDOs.
We worked with our client to implement a digital knowledge management solution, creating a unified repository for market requirements by region, materials, process models, recipes, site and market variations, with clear traceability to each market specific SKU.
Our work made it possible to capture and manage knowledge digitally, which improved collaboration internally and externally across the value chain, accelerating technology transfer, speed to trial and product approval.
Phase 2. Capitalizing on the momentum of digital knowledge management in small molecules, we then shifted focus to enabling the same capability for their drug delivery devices and combination products business units. 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, processes and data, 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 hub is being established to map ISA 88/95 data structures across the extended network and also publish standardized recipe to internal and partner downstream systems such as ERP and MES. This improves change propagation across sites and systems enabling more efficient feedback, recipe data publication 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 development quality management
- Data-driven decisions on network 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.