Trends, challenges and priorities

Digital and technology advances create exciting opportunities for the next step-change in performance in biomanufacturing. Using BioPhorum’s technology roadmap, we understand how market trends translate into manufacturing targets around speed, cost, quality, flexibility and sustainability. IT and digital advances will be crucial to meeting these challenges and achieving these goals.

The digital manufacturing facility of the future needs to consider digital and technology advances alongside organizational perspectives, bridging the gap between information and operational technology while maintaining foundational security requirements. All elements need to be considered in terms of the long-term systemic change towards the digital factory vision and the BioPhorum IT collaboration is delivering important aspects of this vision.

Sensors and data

The use of sensors in manufacturing and the supply chain is increasing. The richness of data gathered lets us look at the relationships between parameters and use these to maintain and improve control in manufacturing.

It means we can find more intelligent ways of managing our assets and explore opportunities such as AI for advanced process control to optimize product quality and yields, which can significantly benefit industry’s speed, cost and quality goals. In asset management, if predicting equipment failure can be done routinely and cost-effectively across the industry, it has the potential to save many millions of dollars through improved maintenance and reduced downtime. Therefore, the Phorum is targeting projects such as smart maintenance and advanced process control with the aim of transforming manufacturing.

Applying digital advances to new products

With new product classes emerging, we must consider their operational challenges and find ways to quickly leverage the benefits of digital innovations experienced from existing products.

The Phorum’s Digital Plant Maturity Model (DPMM) allows members to assess the current digital capability in manufacturing and decide on investment strategies that enable an appropriate digital plant capability across the manufacturing network.

The principles of the model can be applied to emerging product classes to understand, for example, the digital enablers for cell and gene therapy manufacturing. For example, we are working with BioPhorum Cell and Gene Therapy 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.

Pace of change

How can we accelerate digital innovation and achieve industry’s speed, cost and quality objectives? Digital innovation is often managed through targeted proofs-of-concept, leading to a roll-out across an organization. Unfortunately, the people, process and technology challenges to a widescale roll-out result in barriers to change and keeping to existing ways of working, sometimes resulting in lack of progress and missed opportunities.

An example is that AI has been used in other industries for many years to optimize manufacturing processes and deliver step changes in performance; this type of change is only slowly being delivered into biopharmaceutical’s regulated manufacturing environment. There are many reasons for this; however, our challenge remains – how to accelerate the pace of change, considering the technology angles alongside the people and process hurdles to find balanced solutions.

We use pathfinders to explore new collaboration ideas, e.g. Batch release. Process standardization and across sites and Collecting data from different systems e.g., LIMS, EVENT, CAPA) is difficult and time-consuming. Working together to share learning and developing best practice guides, tools, standard processes and templates will overcome existing challenges, drive automation and increase digital maturity throughout the industry. The learning from previous digital projects and implementations can be built into new technology advances like this to accelerate the benefits for member companies.

Cyber security

ThThe 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 manufacturers

Another trend relates to the 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.

Joined-up thinking

Across BioPhorum, there are active discussions around these trends, challenges and priorities. For example, we are working with BioPhorum Technology Roadmapping to see how its capabilities, such as In-line Monitoring/Real-time Release (ILM/RTR) and Plug and Play are being adopted to ensure our contribution is fully aligned.

Phorum leads are articulating their priorities and are ensuring workstreams are aligned to deliver the highest priority outputs. This builds confidence that we are working in the right areas to meet those challenging long-term trends.

Information Technology deliverables 2021

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IT for Cell And Gene Therapy

IT can be simple

Decision-makers, architects, designers and operations managers often find it hard to comprehend the complexity of both biologics and IT for CGTs. A practical way to have productive discussions, ideation and decision-making despite the knowledge gap is to use analogies. The team has identified eleven key analogies that have proven useful, along with best practices and pitfalls to avoid. These were presented as a Readout in July 2021  and will be published later in the year.

Capability architecture

CGT manufacture can typically involve a number of partner organizations:- treatment centers, logistics partners, CDMOs and sponsors, each with their own systems stacks. Many advanced therapies are personalized and are delivered to tight timescales. This affects the IT architecture that spans the ecosystem, and so far the emerging architectures tend to have been focused on the needs of the first CGT product to come to market. As companies bring more therapies to market with different characteristics there is a need for a common set of digital capabilities that can be deployed as needed, across the ecosystem. The team is working on capability diagrams and descriptions that explain what is special about CGTs and help the architect decide an appropriate way forward in their ecosystem. A Readout is planned for October 2021 and these will be published during 2022.

User Stories

With a complex ecosystem, it is important to consider all the actors and personas who will use digital capabilities, to make sure their unique perspectives and needs for visibility, control and alerts with respect to the CGT manufacturing process are understood. The team is producing a set of high-level user stories that articulate those needs and the reasons why. A Readout was delivered in September 2021 and is expected to publish in late 2021 or early 2022.

Lab of the Future

The team has presented the Manifesto: Digital technology-based capabilities for the quality control (QC) lab of the future (published September 2020), at  TRMx (December 2020), BPI East (September 2021), Biovia user conference (September 2021) and will present it at the Japan Bioindustry Assocation (Dec 2021).

Biomanufacturer strategies and case studies

The biomanufacturers and CDMOs in the team take turns at presenting their company 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 have 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 are being written up in the form of a best practices guide, due for publication in early 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. It is expected that more of these will be combined into external publications during 2021 and 2022.

Cyber Security

Following on from the success of the cyber security education series, where the collaboration team were exploring foundation topics such as asset management, patching, resilience, recovery and third party security, getting a feel for the scope of the issues and the maturity of the industry, the team has moved on to explore four key topics through more indepth sprints.

The first of these sprints was a deeper investigation into patching within manufacturing. It can be complex and disruptive. The team identified a framework of “patching barriers” and propose important mitigation actions that manufacturing operations must consider when installing a patch through the  paper Manufacturing patching practices: Safeguarding the manufacturing environment.

The second sprint topic explored what ‘detection’ meant within the manufacturing operations. The initial goal was to define and prioritize the common problem statements as they relate to detection and detection processes within a biomanufacturing operational shop floor. The second ambition was to investigate and identifying mitigations and practices that can be implemented or adopted to overcome these problems. The output of the group is due to be published in December 2021.

The third sprint, which is still inflight, has taken the concept of patching and exploded it out to that of  ‘vulnerability management’ within the manufacturing environment. The team spent some time really considering what ‘vulnerability management’ meant to each company, aiming to have a standard definition and ascertain the scope of work. They are currently investigating the processes, people and technology required for vulnerability management, aim to create a good practice KPI dashboard design and discuss common remediation activities. The outputs of this sprint will be available in Q1 2022.

The fourth sprint, which is also still inflight, has been on the topic of ‘Incident response in the manufacturing operations’. The team have considered what the high level process is, what companies should be thinking about and planning for before an incident happens, during, immediately after and follow up activities. This includes simple suggestions such as a creating a simple communication in the form of a card with the 1,2,3 steps that any first responder should do in the event of something looking abnormal, attached to all applicable machines. Taking the guess work out of important decisions. The team are aiming to produce this alongside a suggested decision framework as a good practice recommendation to others in the manufacturing industry who are struggling with this concept or want to be better, and be more prepared.

The cyber security strategic collaboration portfolio is guided by the subject matter experts themselves, as they go through a six monthly process of prioritizing new topics to work on together. If you are interested in getting involved, finding our more, please contact Lauren Morgan for more information.

Advanced Process Control and Predictive Analytics

The team has continued to work as a sub-team of the cross-BioPhorum Adoption of ILM/RTR program. A key intent of this collaboration is to address the challenges of deploying APC/PA solutions into a regulated biopharmaceutical manufacturing environment, where this path is not well defined.

In the first part of 2021, the workstream developed a view of the overall enablers and blockers impacting the deployment of APC/PA solutions. This information is available internally to member companies. Sometimes, new technologies and approaches are needed to improve enablers and removed blockers, and when identified the team will document these. Going forward, the group will make recommendations to build enablers or remove blockers.

The team is currently working on a  paper of best practices to build advanced process control and predictive analytics capability, regardless of a company’s starting point.

Smart Maintenance

An architecture blueprint for smart maintenance has been drafted and is due for publication in Q4 2021. This is 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 towards fully connected plant. A scale of smart maintenance is being produced that relates back to the tried and tested digital plant maturity model (DPMM).

The team continues to share their experiences of implementing smart maintenance trials and in live production. These case studies bring to life the guidance detailed in the architecture blueprint and will be included as appendices. A template business case, maintenance charter, procurement checklists and retrofit guidance will also support organizations implementing smart maintenance on greenfield or brownfield sites and they are scheduled for release in Q4 2021.

The goals of smart maintenance are to reduce the overall costs of maintenance and energy consumption while reducing downtime and therefore increasing production capacity and safety. This workstream aims to provide practical tools to remove the mystery from smart maintenance and help make it a reality.

Sponsor/CDMO Data Standards

Licensed and contract manufacturers and their partners have an increasing need to share data with each other. Data conventions are inconsistent between organizations and/or plants which means uncertain levels of accuracy and equivalence. Sharing is currently achieved via bespoke interfaces or email which leaves all parties open to all manner of risks. Due to the level of industry regulation, every interface requires validation which takes time and increases costs. The team has reviewed the existing data standards landscape and will produce a gap analysis and proposal for next steps towards practical solutions. This includes sample taxonomies/ontologies for each of the core data areas in scope: Supply Chain, Tech Transfer, Manufacturing and Quality. These samples are the precursors to industry standards and also a clear articulation of industry requirements which will help to identify potential digital solutions with the necessary processing power to take on the heavy lifting. A series of presentations started in June to showcase technology solutions using data from member companies to make it real.

Augmented Reality/Virtual Reality (AR/VR) Applications

Many companies are investing in proofs-of-concept to understand the potential value of AR/VR, 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.

Early 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.

The team has developed industry requirements for AR/VR hardware and software for successful use in biopharma. Valuable discussions with key suppliers have taken place, and the industry requirements will be published soon.

A common use-case of a work instruction for batch line clearance has been selected to work through the issues of deploying an AR/VR solution to support this key regulated manufacturing process.

MES of the Future

Member companies are investing a lot of resources rolling out or upgrading MES (manufacturing execution system) systems at their production sites. This workstream is exploring what needs to be different for future manufacturing operations, considering different options, user requirements and future industry needs.

A survey has been completed to create a baseline of current approaches, challenges and identify collaboration scope. BPIT leaders reviewed the workstream proposal in June 2021 and agreed with the proposed charter and next steps. The goal of the workstream is to create and implement a manifesto for MES of the future that clarifies industry objectives, leading to detailed industry/supply partner discussions on solutions to overcome existing challenges and limitations, due to be published before the end of 2021.

Alongside delivery of the manifesto, the group will continue to share case studies and complete benchmark activity for specific topics of interest.

Community of Practice: Compliance for the Digital Age

This group continues to meet quarterly to share its experiences and has recently reviewed the results of a benchmarking survey regarding the use of digital solutions and the extent of digital transformation among member organizations.

Community of Practice: Digital Plant Maturity Model (DPMM)

The DPMM team have conducted a survey to further understand how the member companies have used and engaged with the topic. The outputs of this survey will be used to inform how the collaboration of members should move forward to further utilise and develop the model.

BioPhorum IT also entered into a partnership with MxD and IAAE 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 developed DPMM tool to serve as the foundation for non-internal surveys and interviews conducted during this FDA funded research.

IT for cell and gene therapy

The workstream has been working on a number of key publications: CGT actors and process maps: Who does what in the supply of different cell and gene therapies​. This publication planned for Q1 2022 will educate IT people on what to expect for different therapy types they may have to support​ CGT digital capability architecture.

Digital capabilities to support the supply of a range of cell and gene therapies​ this publication planned for publication in Q1 2022 identifies common digital capability requirements across multiple therapies, facilitating strategic choices that create a more flexible future​ CGT personas and user stories. It explains what people need the systems to do to support the supply of cell and gene therapies​  and will offer practical tools for business analysis when faced with the challenge of supporting a new cell or gene therapy​.

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