Trends, challenges and priorities
Pursuing digital maturity
BioPhorum IT’s Digital Plant Maturity Model (DPMM) allows members to assess the current digital capability in manufacturing of each plant and decide on investment strategies that enable an appropriate digital plant capability across the manufacturing network. Currently our biomanufacturing members are focussed on uplifting and refreshing the model so that it is relevant in current time to the industry.
IT for CGT
As Cell and Gene Therapy (CGT) manufacturing develops, there is an opportunity to build a digital approach without the burden of legacy. BioPhorum IT works with the BioPhorum CGT community to understand IT and digital requirements through discussions with process experts, resulting in publications describing a new approach to understanding and discussing the ‘actors’ process maps, ‘personas’ and user stories and capability architecture.
Cyber security
The trend for connectivity and digitization in manufacturing and the supply chain increases the amount and value of data used across all connected devices. These can create security challenges that can have far-reaching effects if not addressed. Cyber security is key to resilient manufacturing. Our Cyber Security workstream is working hard in this area. It is engaging with our member’s cyber security operational experts and chief information security officers to understand, strategically and operationally, what we need to do differently, how quickly and more effectively to respond to these challenges. The work includes a series of papers enabling understanding and a dialog about security issues and the different ways of resolving them, focusing on standard practices and maintenance approaches.
Contract manufacturing
Another trend relates to the increasing use of contract manufacturers and contract laboratories. Biomanufacturers are investing in digital manufacturing but when engaging with their complex ecosystem of contract suppliers, the data flows can be inefficient. We are responding to this trend by investigating how we can improve data flows and what core data standards are needed for those IT and data relationships to be much more efficient. Providing a solution for these issues will offer tremendous value to contract manufacturers and license holders as a single, standard approach will be beneficial for everybody when a product is outsourced for manufacture. Currently, we are exploring these options in the Digital Integration of Sponsor and Contract Organizations (DISCO) Workstream.
Information Technology deliverables November 2021 to November 2022
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Milestones
Augmented Reality/Virtual Reality (AR/VR) Applications
Many companies are investing in proof-of-concepts to understand the potential value of AR/VR (often under the umbrella of XR – extended reality), with a variety of use-cases being explored. Examples in user training and process support are common.
The value of AR/VR solutions cannot yet be fully realized in biopharma. For example, some hardware cannot be used in cleanroom/GxP environments. Scaling AR/VR solutions to work in secure and standard ways across all manufacturing facilities is non-trivial. Sometimes, there are shortcomings in product offerings and a common voice of all relevant stakeholders helps to ensure these issues are recognized and addressed.
The industry believes that AR/VR solutions promise much, with strong use cases identified, but without the engagement of internal quality stakeholders, regulators, and an agreed industry voice on the application in GxP, the full potential value will not be realized.
In 2021 the team met with Microsoft global product teams to discuss the HoloLens 2 hardware, and associated MS Guides software. Material prepared for this evolved into a user requirements document for AR/VR hardware and software. Valuable discussions with key suppliers took place, and the requirements are now published.
The team is in the process of writing a risk assessment document to help the industry understand the relevant risk categories to consider purely from the perspective of implementing AR/VR technology. In addition to this a vision paper to describe the framework of how AR/VR technology can support GxP processes where regulatory requirements must be considered is being worked on by the team.
Member company case studies continue to be explored amongst the group.
Cyber Security
The Cyber Education series has published a valued set of documents, setting out approaches to foundation topics such as asset management, patching, resilience, recovery, and third-party security.
More recently the team worked on two sprints. One of these has developed material to support an Incident Response tabletop exercise. This material imagines a cybersecurity scenario that key stakeholders need to address, with additional time-based complexities being added. The exercise can be used to test out the preparedness of technical and business teams to resolve a cyber incident. The template can be used to develop new scenarios too. The material will be published by end 2022. The second sprint has examined the challenges of Vulnerability Management. This information will probably be shared by the end of Q1 2023.
The team recently voted on new sprint topics. The priority is to develop a cyber security maturity assessment and strategy which speaks the language of business and promotes the topic of cybersecurity on the corporate agenda. The second priority is to improve the way we interact with third-party vendors, looking for more standardization and efficiencies across biopharma. The third priority is to work through the challenges of using cloud infrastructure to support operational technology (OT).
The Cyber Security portfolio is regularly reviewed and voted by the workstream SMEs to agree the priority topics.
In 2023 we want to create a space for Chief information security officers (CISOs) to come together to think through important topics related to that key role.
Digital Integration of Sponsor and Contract Organizations
Vision
Between them, the group has shared over 30 case studies and innovations which now form a reference library useful to anyone considering similar projects.
The group consolidated their learning into a vision that will be published in late 2022. This describes the current situation and its problems and the benefits we are seeking from better integration. It lists an industry view of the priorities for integration, which were validated by a survey, with 31 responses from 22 companies. It describes a maturity model for assessing the current state and choosing appropriate targets for the future. The model of alignment in layers cuts through the jargon to focus attention on the areas where new standards will be needed.
Team members now take turns at presenting their company strategy for integration and relevant case studies, showing how the vision is being brought to life and identifying further areas for us to work on.
Future direction
The goal of the program’s ongoing work is to see the vision becoming reality, overcoming obstacles to change, creating frameworks that will make it easier, forging alignment among key players, and initiating progress towards standards.
In 2022-23 some key topics will include cybersecurity, a contribution to the refreshed Digital Plant Maturity Model, and focussed work on a selection of specific integration points such as deviations and certificates of analysis.
Better integration between organizations will make more and better data available faster, giving visibility and allowing processes to be optimized while improving compliance. Manual activities will be reduced, and new partnerships will become easier, allowing the industry to become more agile, and to support the pipeline of advanced and personalized products.
Digital Plant Maturity Model (DPMM)
IT for Cell and Gene Therapies
The IT for Cell and Gene Therapies program has grown to 58 representatives of 20 companies, comprising biopharmaceutical manufacturers, software and equipment vendors, working together to bring about a shared vision for digital maturity in the manufacture of cell and gene therapies.
Vision
The vision for digital capabilities for cell and gene therapy, published 2020 is targeted to educate IT professionals in the distinctives of cell and gene therapies, so that they are productive faster and the solutions they create have better foundations, support more products, and are more maintainable.
IT can be simple: using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies, published at the end of 2021, provides creative and visual ways to bridge the gap of understanding
Team members now take turns at presenting their company strategy for IT to support CGTs and relevant case studies, showing how the vision is being brought to life and identifying further areas for us to work on.
Toolkit
The team has run a number of sprints to create publications and a set of tools to accelerate the analysis and design of systems to support CGTs.
CGT actors and process maps: Who does what in the supply of different cell and gene therapies (April 2022) describes how the required digital capabilities vary according to the type of cell and gene therapy platform.
CGT personas and user stories: What people need the systems to do to support the supply of cell and gene therapies (April 2022) provides a toolkit to support analysis and system design: not just what is needed, but why.
Future direction
The goal of the program’s ongoing work is to provide consistent approaches with reusable methodologies or frameworks that will help speed up the development of IT architecture to support new modalities. In 2022-23 some key topics will include traceability, composable architecture, release, next generation sequencing (NGS) and integration of bench-scale equipment for CGTs.
All of this will accelerate industry alignment and make partnership easier, there’ll be fewer dead-end, unmaintainable, unscalable solutions; more equipment integration and informatics alignment, and better IT foundations to support the future range of CGT products. Ultimately there’ll be fewer deviations and improved patient outcomes.
Lab of the Future
Biomanufacturer strategies and case studies
The biomanufacturers and contract and development manufacturing organizations (CDMOs) in the team take turns at presenting their company’s lab of the future strategy and relevant case studies, showing how the manifesto is being brought to life.
Laboratory equipment and software roadmaps
The team has a process for contacting key vendors of laboratory equipment and software and invites them to present and discuss how their roadmaps support the manifesto vision. The first ten engagements revealed committed plans and potential items for their roadmaps, with an invitation to the team to help the vendors prioritize those future pieces of work via comments and surveys.
Lab instrument integration
The second sprint during 2021 delivered an industry paper on the benefits of progressively sophisticated lab instrument integration. Surveys of biomanufacturers, instrument vendors and lab informatics system suppliers will be used to establish the feasibility of defining an industry position on how to approach lab instrument integration. The sub-team has strong connections with industry initiatives in this area and is influencing the development of standards.
Data integrity
In July 2020, 15 companies reviewed the significant progress they made on improving data integrity in laboratories in recent years but noted the increased expectations of inspectors. They also identified challenges that have not yet been well defined, such as data integrity in the cloud and data from third parties in the supply chain. These unique challenges of data integrity in labs (in the form of a best practices guide) were published by BioPhorum in 2022.
Future direction
The team continues discussions with key laboratory equipment and software vendors about their roadmaps towards the lab of the future. A prioritized set of manifesto topics is the focus for definition and scoping exercises, which usually include a compare and share from most of the participating companies. Based on the topic scoping exercise, periodic prioritization surveys are used to establish new sub-team sprints to create deliverable outputs. Sprints taking place include Standardization of Quality Control (QC) Data Architecture and Infrastructure, as well as innovation topics such as Augmented Reality (AR), Robotics and Voice Enablement to help work towards “assisted scientist” ways of working in the QC laboratories.
MES of the Future
A survey has been completed to create a baseline of current approaches, challenges and identify collaboration scope. BioPhorum IT biomanufacturing leaders reviewed the workstream proposal in June 2021 and agreed with the proposed charter and next steps. In January 2022, the workstream published the MES of the future Manifesto. The manifesto clarifies industry objectives and the focus for 2023 will be detailed industry/supply partner discussions on solutions to overcome existing challenges and limitations.
Alongside delivery of the manifesto solutions, the group will continue to share case studies and complete benchmark activity for specific topics of interest.
Smart Maintenance
Companies are looking for better ways to reduce the overall costs of maintenance and energy consumption while reducing downtime and therefore increasing production capacity and safety. The Smart Maintenance Workstream aims to provide practical tools to remove the mystery from smart maintenance and help make it a reality.
This workstream has written an Architecture Blueprint for Smart Maintenance which is due for publication by the end of 2022. It is regarded as an intermediate level of architecture for smart maintenance and constitutes the first in a series of architecture blueprints helping manufacturers to climb the scale of digital maturity toward a fully connected plant. The team continues to share its experiences of implementing smart maintenance solutions, these case studies bring to life the guidance detailed in the architecture blueprint and will be included as appendices.
A scale of smart maintenance has been developed that is an overlay for the Digital Plant Maturity Model (DPMM).
Internal documents related to a template business case, maintenance charter, procurement checklists and retrofit guidance have been developed or are in development.
Future work planned will develop a manifesto of requirements to share with the industry and its partners. This will set out a vision for smart maintenance with suggested areas for standards and a common presentation of asset health and maintenance data, regardless of asset provider.
External collaborations
BioPhorum IT also entered into a partnership with MxD The Digital Manufacturing and Cybersecurity Institute and IAAE International Academy of Automation Engineering who were awarded funding from the FDA Office of Counterterrorism and Emerging Threats in order to identify the barriers and benefits to adoption of smart manufacturing technology in the medical product manufacturing industry. MxD and IAAE utilized the BioPhorum DPMM tool to serve as the foundation for non-internal surveys and interviews conducted during this FDA funded research.
