Information Technology

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The essential digital capabilities for CGT manufacturing to succeed at scale

Cell and gene therapies (CGTs) is an emerging, high-growth area, but their manufacture is different from established small molecule and biologics platforms in many ways. These range from starter cell variability and traceability for patient safety, to the need for fast turnarounds, very dynamic scheduling and rapid deviation management. All of these, and more, profoundly affect the IT system requirements for CGT. As more CGTs are approved for...

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Cyber security: A standard CMDB data model for pharmaceutical manufacturing shop floor systems

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.

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Connected data, cobots and smart scientists: how to create the lab of the future

Many will recognize that the biopharmaceutical quality control (QC) laboratories need much more digital enablement to align with the rest of the manufacturing environment. Issues range from a lack of automation and data not being captured automatically or consistently for advanced analytics. Change and industry collaboration is clearly needed – and a vision of the future has been delivered by BioPhorum through a new paper, Manifesto: Digital...

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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IT for Cell and Gene Therapy

In 2020 only a few cell and gene therapies (CGT) are approved for commercial use, but hundreds of clinical trials are underway, and demand for manufacturing capability is set to grow. However the manufacturing equipment platform and associated digital capabilities are early in their maturity life cycle, in contrast to the established equipment platforms and digital capabilities for small molecule and biologics manufacturing. This is because...

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Lab of the future

Quality control (QC) labs in the biopharmaceutical industry have fallen behind the digital enablement of the manufacturing environment. Test execution is not automated, partly because a lot of lab equipment cannot yet be controlled digitally. Technicians use non-integrated systems, often with fixed user interfaces based on reports and documentation/paper rather than individualized personal user experiences; they are not guided or assisted by...

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Cyber Security Configuration management database use cases

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.

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Cyber security: Boutique vulnerabilities

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.

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Cyber security: Information technology vs operations technology – a BioPhorum article

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.

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Cyber security: Digital plant resilience assessment tool

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.

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