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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.
Bio/pharma companies proceeding with digital transformation aim not only to collect more data but also use it to improve process efficiency and reliability and product quality. Raw material variability, which has been a challenge for many bio/pharma manufacturing processes, is one of the areas that has the potential to be transformed by new ways of collecting and analyzing data. Making a change in this area, however, requires more communication and transparency between raw material suppliers (who have the detailed data about raw material production) and their customers (who have the data about using raw materials in their process).
In March 2019, GE Healthcare announced a digital data exchange collaboration program with Amgen, with the aim of increasing understanding of the relationship between raw material variability and process performance during the manufacture of biologic drugs. As a part of this initiative, GE Healthcare and Amgen will be installing a connection for data transfer between GE Healthcare raw material manufacturing sites and Amgen’s process development center in Cambridge, MA (1).
“Our collaboration with Amgen aims at using data analytics created through sharing of data and insights to improve efficiencies, performance, and quality of our products and processes,” says Olivier Loeillot, general manager of GE Healthcare Life Sciences’ BioProcess business. “The data insight enables GE Healthcare and Amgen to track and monitor variances in raw materials. With access to such specific data, both teams … [can manage] the effect of raw material variability on process performance during biopharmaceutical manufacturing.”
Amgen has been developing new tools and programs to address raw material variability. Several years ago, the company created an in-house information system to document and store raw material data, but needed a standard file format to allow data exchange between raw material suppliers and users (2). Amgen’s initial work on this format led to a broader industry collaboration that was published in 2017 as ASTM E3077-17, Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers.
The ASTM standard for data transfer is a helpful tool. “The exchange of eData lies at the very foundation of our collaboration, which builds on ease of interoperability, a common data format, and supply chain transparency,” notes Loeillot. Pharmaceutical Technology spoke with Loeillot to learn GE Healthcare’s perspective on the data-exchange program.
PharmTech: What are the key drivers for creating a data exchange program?
Loeillot (GE Healthcare): The data exchange capability GE Healthcare will be installing in collaboration with Amgen [aims to push] biomanufacturing further into Industry 4.0, in which cyber-physical systems collect and interpret data in order to optimize operations, enhance productivity, and strengthen performance reliability. Advanced data analytics will enable both GE Healthcare and Amgen to clearly understand, monitor, and control the effect of raw material variability on process performance during biopharmaceutical manufacturing. This way, both GE Healthcare and Amgen may drive product and process improvements, while advancing performance predictability and consistency. This performance improvement is paramount in substantially mitigating the potential of supply interruptions, safeguarding quality and regulatory demands, and increasing the speed to market, so that the biopharmaceuticals reach patients without delay.
PharmTech: Can you give an example of how raw material variability could affect process performance, and how data exchange will improve the situation?
Loeillot (GE Healthcare): Variability means any inconsistency or unexpected change in raw material. When issues arise, they can have a significant impact on the entire biomanufacturing supply chain. There are many sources of variability, and in many cases, it is hard to identify the root cause. For example, these sudden variations can be contaminants or changes in the chemical composition of the raw material.
While many variables are trivial and have no impact on production, serious raw material variability can lead to inconsistency in the manufacturing performance, quality compliance issues, and ultimately, supply chain problems, which can compromise safety. It is crucial to have solid monitoring, control, and management of the process variability, and this is the main reason we have installed the data exchange program. Scrutinous management of raw material variability brings greater transparency to the supply chain and, in turn, gives customers greater control in achieving a more robust biomanufacturing process.
PharmTech: What role does data analytics play?
Loeillot (GE Healthcare): For GE Healthcare, utilizing data analytics means that we will be able to better predict the impact of raw material variability on manufacturing outcomes, expand our understanding of root causes of inconsistencies, and reduce the risk of supply chain interruptions. At the same time, our customers will have novel access to several types of data, [providing them with] greater control and insights into their biomanufacturing process.
PharmTech: What were some of the logistical challenges to setting up such a data exchange, and how did you solve them?
Loeillot (GE Healthcare): This collaboration aims to establish a seamless data-exchange program between a supplier and a customer. [This goal challenges us to shift] from the traditional way of delivering finished products and data to customers to actually tracking and monitoring raw materials in real-time, while also sharing electronic data immediately with our customer.
GE Healthcare is transferring data through a complex network of internal and external sources directly to Amgen, our customer. The internal connectivity allows GE Healthcare to centralize data, while external connectivity helps us supply Amgen. More specifically, GE Healthcare is connecting legacy manufacturing equipment,which provides information for Amgen to first understand and then perform product and process optimization.The data shared with Amgen will provide unparalleled transparency into the supply chain.
PharmTech: What are the benefits of an electronic certificate of analysis (eCoA)?
Loeillot (GE Healthcare): An eCOA has several advantages over the traditional paper COA. Today, GE Healthcare is developing an eCOA that follows the current ASTM standard format, is easily read by a computer, and is available immediately at the time of product shipment. An eCOA enables customers to quickly access the data necessary for in-depth analytics and process optimization.
In short, more seamless and transparent data exchange has the potential to facilitate “near real-time automated detection when a raw material results in process and/or product variation,” noted Cenk Undey, executive director at Amgen (2). Both partners in this program believe that improved data exchange and other digital tools will enhance troubleshooting and process optimization for both drug manufacturers and their suppliers.
1. GE Healthcare, “GE Healthcare announces digital collaboration with Amgen to improve biomanufacturing performance reliability,” Press Release, March 11, 2019.
2. C. Undey, “Amgen’s Digital Transformation: Linking Raw Material Data from Suppliers to Patients,” www.gelifesciences.com/en/us/solutions/bioprocessing/knowledge-center/amgen-linking-raw-material-data-from-suppliers-to-patients, March 2019.