Transforming the Biopharma Supply Chain and Analytics Capabilities with eData

A digital data transformation is underway in biomanufacturing. Digitalization is transforming and accelerating decision-making and leading to significant improvements in productivity, while providing comprehensive support to end-to-end supply chain integration. This transformation isn’t happening overnight but rather the journey to “Biopharma 4.0” is a step-wise evolution from paper-based systems to a fully automated and integrated, adaptive, “lights-out” smart manufacturing plant of the future.

Read more about

• The Transformative Benefits of eData
• Challenges on the Digital Transformation Journey
• The eMERGE™ Electronic Data Sharing Program

The Transformative Benefits of eData

An essential component of this transformation is the conversion of paper-based data to an electronic format, known as “eData”, which can be transferred, received, and available at the right time, in the right place, by those who need it. Among the benefits of eData are more efficient resource management, elimination of manual errors, reduced labor requirements, and the use of advanced process control monitoring to identify and understand process variability using predictive analytics (Table 1). Adoption of eData offers the potential for greater supply chain visibility, more efficient operations, reduced risk, and improved productivity that will ultimately benefit patients. eData also offers the potential to shorten the duration of the quality control release process, improve control of warehouse inventory, reduce verification time and delays, and facilitate next generation manufacturing.

Table 1. Enhancements to the manufacturing workflow enabled by eData.

Manufacturing improvements	Supply resilience
Efficient use of resources Process improvements Build predictive analytics Automated process control	Supply visibility More efficient operations Risk reduction Improved productivity for patients

Challenges on the Digital Transformation Journey 

While the integration of eData into drug development and manufacturing offers many advantages, there are also obstacles:

• Poor connectivity among disparate legacy systems
• Limited management support due to perceived high costs and security concerns
• Limited transparency between drug manufacturers and suppliers
• Absence of data sharing standards in the biopharmaceutical industry

One of the foundational challenges is the continued reliance on paper-based systems which highlights the lack of digital maturity and limits opportunities to improve productivity and supply chain resilience. Paper-based documentation systems are slower, prone to errors due to manual data entry, and result in inefficient manufacturing operations and limited supply chain transparency. 

The eMERGE™ Electronic Data Sharing Program

The eMERGE™ digital data sharing program is a standardized solution for the automated exchange of electronic data between suppliers and biopharma manufacturers, as end-users. It is designed to accelerate and facilitate sharing of raw material and consumables data, and the associated logistics data from suppliers, which can be directly integrated into end-user’s manufacturing operations and data management systems. The data sharing program is also compatible with existing process monitoring and analytical systems.

Integrated Quality Track: eData for Analytical Applications 

In many cases, raw material information is paper based. By converting paper records to eData, biopharmaceutical manufacturers can establish a raw materials database that can be leveraged to identify process trends, develop predictive analytics, and ultimately, establish an adaptive process control system. If a process or a result is found to be out of specified limits, access to this type of electronic data also accelerates the investigation of root causes and implementation of corrective actions.  This results in less production downtime for biopharma manufacturers and supports the verification and validation processes expected by regulatory bodies.

The eMERGE™ Program provides product certifications, such as certificates of analysis (CoA), certificates of quality (CoQ), certificates of conformance (CoC), etc. in an extensible markup language (XML) machine readable format based on the ASTM E3077-17 industry standard. This standard was released in 2017 and provides a guideline for the eData transfer of production raw material and consumables data from material suppliers to pharma and biopharma manufacturers.

The eMERGE™ program provides:

• Secure and seamless eData exchange through a standard platform solution
• Standard file structure and data format providing consistency, reliability, and flexibility
• A foundation for implementation of advanced analytical and logistical solutions

XML is a universal data format compatible with all software packages and data management platforms used by biopharma manufacturers and includes standard fields for electronic signatures, supply data, measurement parameters, QC results, and much more. Data can be integrated with existing operational systems and used in different applications including real-time monitoring and reporting.

Integrated Supply Track: eData for Managing Logistics and Supply Chain

Electronic data exchange is also essential for managing logistics and supply chains, to ensure that the timelines for drug production are met with consistent and efficient operational performance.  Achieving this consistency relies on a seamless workflow, that includes efficient receipt of inbound raw materials and consumables, and timely incoming quality review, approval and final release to inventory for use in production.

In many organizations, the process for managing inbound materials relies on paper-based systems or email; many suppliers communicate the status of orders and shipments by gathering information from an enterprise resource planning (ERP) system and sending this information to customers via email. Unfortunately, this approach lacks the real-time data visibility and accurate reporting needed for an optimized global pharmaceutical supply chain. Patchwork solutions addressing pain points in this type of workflow, generally don’t work well with existing operational systems and other supply chain platform solutions. This results in a disconnected process prone to inefficiencies, errors, increased costs, and production schedule delays.

Product certificates, packing lists, and delivery notes are typically included in the shipment boxes or containers, and/or provided as PDF downloads from the supplier’s websites. The customer’s Receiving Team manually checks products received against purchase orders and enter relevant shipment, order and product information into their warehouse ERP systems to complete the Goods Receipt. All raw materials and consumables proceed through the incoming QC review, approval, and quality release process, with select materials requiring additional QC testing based on specific requirements.  In some instances, materials will need to be quarantined until QC tests are completed and the materials are verified.  Quality test results and approvals are then entered manually into the ERP Systems, Warehouse Management Systems, and Quality Release Systems. The materials are then released into warehouse inventory, where they can then be accessed based on production demands and requirements. These materials will then be staged and prepared for production, which may include various operations, such as picking, dispensing, weighing, packing, and kitting dependent on the specific materials.

Each of these steps could lead to potential operational delays and errors. By contrast, digital logistics data from suppliers could eliminate queue times, manual data entry errors, etc. Leveraging eData enables biopharma manufacturers to create a modern, digitally enabled inbound supply chain process across the logistics workflow which offers a number of benefits including:

• Improved visibility of inbound shipments
• Reduced labor costs required for manual data collection, entry, and review
• Accelerated timeline for incoming material goods receipt process
• Optimized incoming material review, approval and quality release process

With digital transformation and real-time access to critical data, biopharmaceutical supply chains can evolve from static, siloed states to highly integrated, resilient systems and processes. 

In addition to supporting analytical applications, the eMERGE™ program enables more efficient handling and flow of raw materials and consumables within biopharma production. The first application of the eMERGE™ logistics program will be focused on accelerating the goods receipt and release processes for biopharma manufacturers. These eData files will be provided in the XML format and can be integrated directly into manufacturer’s warehouse management systems, ERP systems, and internal batch record systems. The use of eData in this application ensures timely communication and confirmation of shipments and enables biopharma manufacturers to efficiently move incoming materials from receiving to inventory.

Key value drivers and benefits of this initial logistics eData file are summarized in Table 2. Greater visibility into the progress of goods in transit leads to improvements in on-time delivery and flexibility, as well as early access to critical information. Optimizing receipt of goods minimizes the potential for data entry errors and enables operators to focus on value-add activities. Warehouse and inventory optimization can reduce cycle time and improve environmental impact by reducing rejected or aborted deliveries and unnecessary paper usage.

Table 2. Use of eData leads to process improvements and enables warehouse and labor savings.

Transit Visibility Improved on-time delivery and flexibility. Receive information early.	Inventory Warehouse capacity optimization Cycle time reduction
Goods receipt Optimization Manual errors reduction Labor reduction	Environment Reduced failed deliveries. Less paper

Future developments in the eMERGE™ program will support initiatives such as right size packaging, seamless goods production flow processes, improved supply chain visibility and enable demand and supply optimization through integrated ERP platforms. Collectively, these strategies will arm biopharma manufacturers with real-time data to drive decision-making and enabling them to quickly adjust to market and industry disruptions. 

 

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