In the Biopharmaceutical industry, the process of technology transfer plays a critical role throughout the product lifecycle, from research to commercialization of a new therapeutic. However, traditional processes are slow and costly. The average technology transfer process takes around 20 months, involves around 30 cross-functional experts and on average costs $5 million1 . This impacts costs, time-to-market and competitiveness.
Tech Transfer – what is it?
Tech transfer is defined as the transfer of product and process knowledge between development and manufacturing, and within or between manufacturing and testing sites to achieve product realization2 . It is about transmitting proprietary knowledge and experience about a product, the associated manufacturing processes, and/or the relevant analytical methods to a receiving manufacturing site. The site will then be able to carry out the necessary activities to produce the product at the appropriate scale. This shows that tech transfer is critical for the successful manufacturing and delivery of a product. It is one the key aspects that define speed to market.
Why is it so hard?
Tech transfer is complex. It involves many different departments, sites and experts with different functions across the organization. Typically, they use different processes and systems that are disconnected. This leads to scattered information that is difficult to access and re-use, making knowledge transfer slow and incomplete. An example of the consequences is that scientists cannot start to plan and prepare activities early in the process.
Documentation is a key part of tech transfer. Because tech transfer is a logical procedure controlling the transfer of any process along with its documentation and professional expertise3 , it should not come as a surprise that traditionally tech transfer is document-centric. Information delivered in documents is not structured and difficult to re-use. With up to one hundred documents involved in a single tech transfer, this results in significant delays and high costs.
Tech transfer is collaborative. However, collaboration is difficult between people located in different departments, sites and geographies. Experts are traveling around the globe for knowledge transfer, which is very costly and time consuming. Additional information exchange via traditional means like email is cumbersome and insecure, bearing the risk of IP loss through cyberattacks.
The Solution: Digitalization and Integration
Tackling the challenges related to tech transfer complexity, documentation and collaboration often requires a radical transformation in organizations. Digitalization and integration are proven key elements to making tech transfer efficient and successful.
Digitalization will lead to data-centricity and improve workflows. Organizations should move away from paper and electronic documents (“paper-on-glass”) that are rigid documents with buried information. Digitization—the process of moving from analog to digital forms—is not enough. Companies that embrace true digitalization (the use of digital technologies to change a business model4 ) will be able to truly leverage their data and knowledge. Contextualized data and meta-data lead to improved understanding and easier data re-use. In fact, the creation of structured documents based on templates that are automatically filled significantly improves efficiency and the quality of the documents.
Integration allows the data to flow between departments and sites, between experts and receiving units, between systems and instruments and between processes. Due to the complexity of tech transfer, point integrations will be immensely difficult to implement and maintain. The answer is a platform that works as a collaborative environment and provides a real-time view on all data and activities. A platform will provide true connectivity across the product lifecycle, which is the core of tech transfer.
Both digitalization and integration are core principles of Industry 4.0. Making these principles part of a transformational tech transfer strategy and leveraging the enabling technologies is a proven approach for successful tech transfer.
Tech Transfer 4.0
Industry 4.0 refers to the intelligent networking of machines and processes for industry with the help of information and communication technology. It builds upon data models and data mapping across the end-to-end product life cycle and value stream. All the technologies in Industry 4.0 need to be seen in that perspective, whereby integration is key5 . Industry 4.0 integrates processes vertically, across hierarchical levels of the entire organization, including processes in product development and manufacturing. It also horizontally integrates systems across the various production and business planning processes5 .
A network of machines that are digitally connected with one another, and create and share information that results, is the true power of Industry 4.0. This is a compelling value proposition for tech transfer. Hence, “Tech Transfer 4.0” must be digital, enable vertical and horizontal integration and ideally allow for leveraging new technologies. With this, organizations will be able to reduce costs, increase agility, manage their knowledge, speed time to market and increase competitiveness.
Vertical & Horizontal Integration
An example for vertical tech transfer is the integration of development and manufacturing. In development, scientists work on the creation and the scale-up of the manufacturing process. The recipe will be transferred to manufacturing for the production (for clinical trials or commercial product). Linking the specification of the product and process to the manufacturing facilities will help decide if the product can be manufactured in any of the internal facilities, if new capacity is needed or if a partner (Contract Manufacturing Organization) will produce it.
A second aspect is the development of analytical methods to test the quality of the product. The methods are linked to the product and its specifications. The method will be transferred to the Quality Control lab to execute the test to decide if a batch can be released and if the certificate of analysis can be issued.
An example for horizontal integration is the transfer of manufacturing processes / recipes between different sites. This also includes the extended manufacturing network with partners like CMOs (Contract Manufacturing Organizations) that will benefit from this knowledge as the receiving units. The receiving units will use the production process blueprint to reach the “golden batch” as a reference for future production1 .
The horizontal integration of different testing sites will help the laboratories to standardize the execution of the analytical methods across the organization and achieve consistent, comparable and reliable test results for batch release.
BIOVIA & Tech Transfer 4.0
BIOVIA delivers a broad range of capabilities for manufacturing data, quality documentation and the laboratory in the cloud and on the platform that support a “Tech Transfer 4.0” strategy.
With BIOVIA, you can digitalize your data and workflows. This allows you to connect, automate and streamline your processes and document creation and to re-use data and knowledge across the organization. Integration and data access enable you to monitor and improve processes. Users across the product lifecycle and the larger enterprise network can collaborate in an efficient, secure and controlled manner across departments and sites.
We help you making complex tech transfer easier, faster, more agile, more reliable, more efficient and truly successful.
2 FDA Guidance for Industry, Q10 Pharmaceutical Quality System
3 Annex 7, WHO guidelines on transfer of technology in pharmaceutical manufacturing, World Health Organization, WHO Technical Report Series, No. 961, 2011
5 Industry 4.0 and the fourth industrial revolution explained