There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.
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This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.
Lab of the Future: Manifesto: digital technology-based capabilities for the quality control (QC) lab of the future
Jul 2020 | Information Technology
Most quality control labs in biomanufacturing have not yet achieved digital transformation. Lab processes are often manual which is slow and leads to errors and variability as well as long lead times.
Now those traditional ways of working are further challenged by the drive towards inline monitoring and real time release testing, and by new cell and gene therapies with tiny batch sizes and short shelf-lives.
The lab of the future is digital and requires much stronger IT for demand management and process automation, increasingly informed by data analytics and connected to manufacturing operations. This will be enabled by stronger IT security and operations, systems interoperability and governance, and data aggregation using common models, analytics and visualization.
Huge changes in lab personnel skills and culture are needed to work with the systems and the data in these new ways.
Pharmaceutical manufacturers are developing and using Configuration Management Databases (CMDB) to maintain inventories of the IT and automation assets used by the manufacturing and laboratory systems at their production facilities. A CMDB can provide access to accurate data, including available assets, where they are, how they are configured, and the relationships that exist between them; all of which are vital functions for lifecycle management, change management, incident management and patching.
The information model typically used by the standard CMDB installation is based on the idea that all systems used by the enterprise are software based and described by a class of objects called an application. This does not always align to the needs within an operations technology (OT) environment. Therefore, the BioPhorum Cyber Security members, using their extensive combined knowledge, have collaborated to design a common information model describing a manufacturing system detailed in a shop floor/OT CMDB. The proposed model is intended to be a free, reusable, standard structure which can be adapted for specific company needs, providing a good starting point for configuration data modelers working in the OT space.
In pharmaceutical manufacturing plants, it is sometimes the case that there is no single place to view an inventory of manufacturing assets. Conversely there may be many data sources with manual processes required to compile a single view. This is a problem for the entire enterprise, not just manufacturing; it is a constant and ongoing balance of enterprise (IT) vs manufacturing (OT) tools, policies and proceedures.
Managing this asset information can become a significant manual effort. Without trustworthy data, there is an unclear view of the cybersecurity risk that assets contribute to the manufacturing plant and enterprise. The absence of good information makes planning of patching and lifecycle management exceedingly difficult.
This compels manufacturers to develop Configuration Management Databases (CMDB’s) to maintain inventories of the assets used at their production facilities. Here the BioPhorum Cyber Security members have been investigating the underlying use cases that drive the design, needs and benefits of each member’s CMDB application/s. Through a compare and share process, they have asked the questions “What are our peers doing?”. This paper starts to draw parallels and highlight differences. It gives an insight into the complex and diverse ways of setting up, maintaining, and managing a manufacturing shop floor CMDB.
With each new challenge, organizations are working to improve their response and reduce the time and effort required. Companies are all investing in routine patching where possible, reducing this activity in urgent situations, as well as investing in other mitigation options such as isolation where appropriate – more options means reduced impact. This paper provides a summary of what the members of the BioPhorum IT Cyber Security Workstream are doing.
This paper characterizes this framework, and the associated mixed environments, to illustrate the drivers and success metrics for the key functions of business management of information systems, and that of plant-floor instrumentation and controls engineering. For people working in this arena, this paper will help develop an understanding of this landscape and foster a cooperative approach to implementing network resilience and cybersecurity solutions that allow more robust and secure delivery of essential drug products to the market.
As the maturity of digital manufacturing plants increases, so does the risk of a cybersecurity or other digital incident. A successful phishing attack, for example, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer. A company’s ability to minimize the risk of a digital disaster in its manufacturing plants, and quickly restore operations if one occurs, is a vital area for investment to ensure delivery of drug products to patients. To do this, biopharmaceutical manufacturers must understand the cyber resilience at their differing plants and how each site fits into the context of their overall business.
Sep 2019 | Information Technology
Many biomanufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services. Typically linked using customized, electronic, point-to-point connections. These connections can be expensive and slow to set-up and expensive to update in response to changing market demands. There is no dominant technical solution that monitors the condition and location of shipments, and that enables companies to adopt different solutions for different regions and partners. There is a need to raise the awareness of software vendors of this unmet need and the real interest of many industry stakeholders if a suitable LSP integration solution was available.
This paper provides an overview of the current needs of manufacturers and their technical integration with their network of LSPs. It contains a high-level requirements specification for a common, cloud-based, integration platform, that would reduce customization and multiple point-to-point solutions. The specification is designed to help technology companies develop this services. Informal benchmarking across member companies indicates that ‘collaboration hub’ use would deliver a 50–70% saving in time and cost when linking to a new partner. These benefits would be realized by both partners making the new connection.
This Companion document, to be used alongside its original guidance ‘Guidance on the use of Agile in a GxP environment’. It provides more practical advice on how to implement agile in a GxP environment. The Companion is less about ‘what is Agile’ but more ‘how to do it’ in the biopharmaceutical arena. The Companion details five levels to full Agile working that will help companies determine what level they are currently at and what they need to do to progress to the next stage. This approach will help companies understand how to implement Agile in GxP environments more rapidly and effectively.