Digitisation of manufacturing is a critical step in the automation of cell and gene therapy production processes. The kick-off meeting of this Special Interest Group included a hearty discussion of the current state of digitisation in these industries and defined the objectives for the group going forward. The 16 participants included subject matter experts in the areas of cell and gene therapy manufacturing, data analysis, informatics, automation and raw materials suppliers.
State of the IndustryThe state of the cell and gene therapy industry was explored from a variety of perspectives including operations, equipment, and information technology. Members of the working group agreed that digitisation is in its infancy for cell and gene therapy development and manufacturing with many challenges to overcome including:
- A cloud infrastructure is needed to allow generation, sharing and management of data in a digitized, centralized storage platform so that data generated at one location can be accessed by other sites, computed, and analysed in real-time.
- The need to establish digitized data management as early as possible in a company. This is valuable to the organization not only for ultimate approval in the marketplace, but also helping to ensure success with a commercialized supply chain that is efficient and economical.
- The conversion of data to true information. If a company isn’t using information for data-driven decision making and building knowledge over time, it is a loss to the organization.
- The need to support condensed timelines for clinical trials, registration, and market authorization. The ability to make changes after market authorization, could be something that becomes attractive for the field. Investing in digitisation earlier can be an enabler for this.
- Use of digitisation on the academic side. This will make tech transfer much easier from discovery to translation into industry. Additionally, the industry needs to train people towards a digitized manufacturing mind-set as early as discovery in academia.
- The massive diversity of digitisation tools available to cell and gene therapy companies. The vendor space is fragmented while the desire is for fewer systems and better consolidation of data.
The group also highlighted the fact that digitisation standards allow a plug and play of different pieces of equipment in a seamless fashion. The need for universal standards was likened to the wireless industry by a SIG participant.
“My Verizon phone can talk to T-Mobile phones or AT&T lines seamlessly, and that is the standard this industry or the pharma industry as a whole needs, not an AT&T-specific standard and a Verizon-specific standard, because then we will fail at some point.”
Looking AheadFollowing the in-depth exploration of the current digitisation landscape, the group defined three objectives for upcoming meetings:
- Develop a business case, guidance, and tools to help support the evolution towards digitalization. The group intends to explore the reasons why digitalization is seen as such an important progression of the field and discuss the current state of data generation and handling in ATMP manufacture, the fragmented landscape in this field and the challenges associated with producing data, storing and analysing it. Key questions that must be addressed include:
- What is meant by ‘data-driven’ decisions?
- What are the practical benefit of real-time data analysis?
- What are the hypes and what is actually required?
- What are the tools, mechanisms and approaches which could be used to implement an effective digitalization strategy and what are their pros and cons?
- How do we prioritize the digitalization effort?
- How do we integrate the bigger picture with local, specific tasks?
- What principles, such as data integrity, are required to build a robust and industry-relevant digitalization strategy?
- Frame the data management and governance requirements, including knowledge management and data mining, to give companies the flexibility of integrating different systems. This objective includes data integrity policies, systems integration/compatibility, authorisations and governance, metadata, data structures and databases.
- Outline requirements for workforce training on the proper use of digitisation tools including clarifications about data-driven strategies and the purpose of collecting and using data in an agile manner. The group will explore the skills of the current workforce and identify gaps, future shifts in skills, and the suitability of current infrastructures and technologies. Different applications will require different skillsets in the data generation/utilization pipelines while quantifying resource utilization, such as space, staff, equipment, can be used for time-and-motion studies for capacity modelling and resource optimization.
- Further define the three objectives outline above.
- Examine interconnectivity with the other working groups and ways this group can collaborate with and support them as what goes on in the manufacturing facility is intrinsically linked to the supply chain and all other stakeholders (patients, hospitals, tech providers, etc.).
The Automation Special Interest Group (SIG) was created by Phacilitate in 2017 to discuss and propose solutions to automation challenges presented by cell and gene therapy manufacturing. Since that time, we have advanced this mission by identifying key objectives, hosting meetings with industry experts to explore and address these objectives and releasing a report for the wider industry to use as guidance in their automation efforts. In 2021, we evolved the SIG into a parallel track of year-long working groups, each focused on a different area.
Catch up with what was discussed at the June 2021 meetings with this blog series:
2 - Vein-to-Vein Tracking and Supply Chain Digitisation
3 - Automating Release for Autologous Products
4 - Modularity and Flexibility in Closed Systems
5 - Aligning the Automation and Technology Roadmap to the Regulatory and Process Development Roadmap