With close collaboration among suppliers, end-users, standards organizations, and regulatory authorities, eData exchange platforms will enable more informed, efficient, and timely decision-making across the entire biopharma product life cycle and value chain.
Significance of eData Exchange
With the advent of Industry 4.0, there is the potential across all industries, including biopharma, to implement new innovative business solutions using digital tools and capabilities. The availability of technologies, including cloud-based systems, artificial intelligence (AI), machine learning (ML), and others is a key driver of this digital transformation. The evolution of these technologies and capabilities provides many opportunities to enhance business processes across the enterprise. However, the ultimate value is when these technologies are contextualized, organized, and optimally integrated for maximal application across operations to achieve Pharma/Biopharma 4.0.
Even if these technologies are implemented in various sections and applications throughout an organization, they cannot fully enable the potential capabilities and resulting benefits without data accessibility and sharing. eData exchange involves sharing critical pieces of information that can be then directed into (or integrated into) systems that customers use for analytics and/or to redefine their approach to logistics.
Leading technology adopters have implemented automation solutions and various forms of real-time monitoring capabilities. However, there are still critical pieces of information that are not available in easily accessible and usable digital formats. This information can currently be collected manually in Excel and PDF files to evaluate specific situations. But this approach lacks real predictive power; as analysts would still need to physically investigate any out-of-spec situations to identify root causes and implement corrective actions.
True data sharing, however, not only enables rapid identification of drivers of variability that can then be quickly addressed, but also predicts potential future issues against which preventive measures can be proactively taken. It can also enable accelerated verification and release of certain raw materials and eliminates the need for manual transcription which carries measurable costs and is a source of errors. The overall result is significantly reduced out-of-spec occurrences. When they do happen, the investigation into root causes is no longer manually intensive and can be conducted more quickly as well.
Once a history of performance is established, automation of these analyses using AI and ML will provide even faster outcomes. Ultimately, the goal is to achieve a fully adaptive control model and system that is self-correcting. Operators no longer need to deal with out-of-spec situations or perform investigations but can instead focus on more value-added activities, recouping not only lost time, but lost opportunities as well.
In essence, eData is a crucial enabler from an analytical and logistics perspective. It facilitates the use of digital technologies to enhance and improve operations from discovery to the patient across the full product life cycle. The takeaway is that legitimate data sharing will be fundamental for drug developers to stay competitive and create more enhanced therapies in the future.
First Standard as a Starting Point
eData solutions have been implemented in several other industries, and there are a host of use cases, such as the automated process control and semiconductor sectors. However, the biopharma industry is highly conservative and not yet digitally mature, with many companies still using legacy paper-based tools and processes. Often, the perceived cost and quantity of work needed to implement data sharing can be daunting.
The first step to overcoming that is to establish universal standards. It is simply not possible for each member of the biopharma supply chain to develop its own custom solution for data sharing. Vendors cannot develop different solutions for each customer, and customers do not want to receive data in different formats from different vendors.
International standards developer ASTM International, formerly known as American Society for Testing and Materials, took the first step in 2017 when it issued a new standard (ASTM E3077-17) via its biopharmaceutical subcommittee. Although it has not yet been widely adopted, this standard provides a starting point for creating data-sharing solutions in a sustainable, standardized manner. It defines the data format and file structure, including the taxonomy and nomenclature, that are essential for the electronic exchange of data and secure ingestion by customers into their data-acquisition platforms.
Using this standard, it is possible to develop initial, specific use cases for identifying incremental benefits, as well as to help identify other applications where additional standards will be required. These use cases will address areas where customers are likely to experience the highest return from data-sharing solutions.
Companies involved in these first pilot programs are evaluating their ability to securely ingest incoming data, as well as performing end-to-end validation of the data fields being provided to ensure that they can be received and used by their systems in the intended manner. They are also observing the tangible benefits — accelerated process optimization, advanced process control, more robust predictive analytics, and others — and measurable impacts on return on investment (ROI), which will help make a greater case for further adoption.
In addition to demonstrating the feasibility and benefits of eData exchange, the initial use cases based on ASTM E3077-17 will also help vendors, like MilliporeSigma, understand what customers might be looking at on a more holistic level including the ideal output of these analytics and how to enhance supply chain operations via data integration.
Collaboration on Initial Use Cases
No company can be expected to fully move to digital solutions and eData exchange at once but leading technology adopters are interested in piloting towards the aforementioned use cases. For these projects to be successful, there must be collaboration. Everyone involved must have a full understanding of the current customer systems and how the data will be used so the key pieces of information can be properly identified.
Collaboration is also crucial for helping vendors understand customer goals for data sharing. That knowledge is necessary to identify specific raw materials and other products, such as cell culture media and its trace-element content, as well as critical data for other consumables used in the biopharmaceutical manufacturing process needed in the future.
eData connectivity is just the starting point for a digital transformation journey. That first connection actually creates endless opportunities; that is where trust and collaboration really get established. Once customers begin leveraging eData sharing, they will better understand their processes and the factors driving process variability. At MilliporeSigma, we are anticipating that new process knowledge will be shared with us, so that we can use it to develop optimal future products to support evolving customer needs.
Flexibility with XML
One of the key features of ASTM E3077-17 is the use of extensible markup language (XML), a markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable. It is a universal data format that can be used by different software packages and applications, thus affording tremendous flexibility in terms of systems and interfaces.
XML data can be used in laboratory information systems (LIMS), analytics systems, and back-office systems, among others. In addition, users can take large chunks of data or select specific data fields, and the specific type of analytics software used by the customer can be flexible. Perhaps as importantly, information from multiple vendors, including a supplier’s supplier, can be included in the ASTM file structure if required by the customer.
Data security remains a key issue. Data are only shared across secure connections. Customers then overlay their own data management and control systems, which adds more flexibility. The customer determines what systems it will use depending on how the data will be used.
Don’t Forget the Logistics Benefits
It is important to remember that product quality data used in process analytics is not the only key application that can be enhanced by electronic data sharing. eData exchange can also have a significant, positive impact on various logistics- and supply chain–related applications. The COVID-19 pandemic highlighted the need for more digital linkages — and hence greater visibility — between suppliers and customers all along the biopharma value chain.
eData exchange can play a central role in the digital transformation of logistical processes, including inventory management, order replenishment, warehouse optimization, and risk management. Contract manufacturing firms would benefit greatly from this type of data sharing.
In the logistics/procurement/finance space, the general approach to data sharing is based on electronic data interface (EDI) technology. EDI is more of a guideline and format than a standard, so more work will need to be done to establish standards specific to the biopharma industry.
Potential Beyond Commercial Applications
While initial attention is understandably focused on applications for data sharing that impact the commercial aspects of the biopharma industry, particularly commercial manufacturing of existing products, there are many other areas for which eData exchange can improve efficiency, productivity, and effectiveness.
Integrated digital information exchange has the potential to enhance and accelerate drug discovery, process development, clinical trials, and scale-up to commercial manufacturing. The question regarding what can be achieved by feeding back data from the production side to the other stages of the product life cycle is one that will be addressed in the near future.
It is also possible that once data sharing is implemented, manufacturers may find that less or different analytical testing is necessary. Greater process understanding enabled by eData exchange could reveal testing on parameters that have no impact on a process or, alternatively, identify parameters that should be more closely monitored. These are a few examples of areas that can also benefit from data sharing. There will be many others — and a whole host of benefits — yet to be identified.
Migrating to an Improved Standardized Platform Solution
At MilliporeSigma, the ASTM E3077-17 standard is being leveraged for the development of the eMERGE™ eData platform. This solution is intended to ensure drug manufacturing predictability and control via a seamless, user-friendly, and customer-centric digital experience across the biopharmaceutical supply chain. It is compatible with various commercially available analytical tools, including our Bio4C™ ProcessPad, which provides complete data integration, analytics, process monitoring, and visualization capabilities.
MilliporeSigma is currently focused on gathering information from legacy enterprise resource planning (ERP) and LIMS and translating it into XML files that can be delivered electronically. The eMERGE™ Program will initially include electronic certificates of analysis (CoA), certificates of quality (CoQ), and other product certification data as needed.
Impact of a Large Installed Base
With the broad portfolio of products offered by MilliporeSigma — including cell culture media and ingredients, chromatography resins, active pharmaceutical ingredients, excipients, single-use manufacturing systems, filters, and sampling solutions — there is a large installed base of customers using our materials and solutions, which are crucial across the biopharma manufacturing spectrum. As a result, we have insights into the types of information that can be easily shared while having a measurable impact on helping our customers improve their key processes.
The established relationships we have with our customers provide a further advantage as they already depend on our products. Once clients implement and enable the benefits of data sharing, they will expect the same level of support for products they purchase going forward. The knowledge acquired through data sharing with customers will also enable us to develop better solutions for them. In the future, when we add the ability to provide critical information that helps our customers discover and produce novel drugs, they will realize even greater benefits that can be linked back to MilliporeSigma products.
Another potential impact for us will be the ability to apply our growing knowledge and experience about eData exchange in the other direction — with our key suppliers. MilliporeSigma itself can gain significant benefits if we receive the same types of information from our suppliers via data sharing. In addition, through those connections, we would be able to provide even deeper insights to our customers, with the ultimate goal of improving patient outcomes with more effective lifesaving medicines in the future.