Each supplier of single-use technology products has an implicit obligation to characterize the materials of construction used in the manufacture of its products and to share that information with its customers. Generating that data requires significant investments in people, time, and money. Sharing that data is a contentious issue with legal, proprietary technology, and scientific integrity ramifications. Ultimately, this could increase the risk to patient safety and medication efficacy. Centralizing and simplifying access to these data sets may save lives.
Sterile process liquids can spend weeks, months and even years in a single-use container. Preserving the concentration, purity, and structural characteristics of sterile process liquids used in the manufacturing of biologics and vaccines is of paramount importance to safeguard the potency and efficacy of the final drug products. Using single-use products made of well-characterized materials is crucial to help ensure the liquids will remain unchanged and viable prior to use.
The quality and characteristics of the construction processes and materials affect the mechanical and physical properties, biological compatibility, and extractables and leachables profile of the finished single-use components and finished products, having a direct impact on the products’ ability to preserve the safety and integrity of the stored sterile process liquids. Therefore, it’s imperative that the manufacturers of single-use products characterize the extractables profiles of those construction materials that constitute the wetted surface of the single-use product to help ensure that those materials are not additive, reactive, or absorptive.
Regulatory agencies require from biopharmaceutical manufacturers a demonstration of the suitability of process liquid containers for their intended uses. The BioPhorum Operations Group (BPOG), a consortium of biopharmaceutical manufacturers and single-use product suppliers, has developed standardized extractables and leachables testing methods for single-use product construction materials, and it has published a best practices guide for extractables testing of polymeric single-use components used in biopharmaceutical manufacturing.1
Along with test method guidance, BPOG provided recommendations related to data reporting format and timing. Although many suppliers have tested and reported extractables data, and continue to do so using a common protocol, a challenge has developed related to data sharing. As a supplier of single-use products, many of our customers contacted us requesting full extractables data sets for the single-use product purchased from us. Fulfilling this obligation requires collecting extractables data sets for those supplier-purchased components. Although accessing the supplier’s data is usually fairly simple, sharing the data is more complicated. Some suppliers allow open sharing of their data. Other suppliers have firm restrictions on sharing it.
Data ownership creates a significant challenge for suppliers
It is rare that a supplier of single-use technology products is 100% vertically integrated. More often they buy from each other, creating an interesting market dynamic where a competitor can also be a customer. Because of this, suppliers are wary about granting open access to their highly confidential data and risking closely guarded trade secrets that could be exposed. How then, do suppliers meet their obligation, tacit or otherwise, to generate some very expensive data, share it with their customers, but also keep secret their proprietary information?
A shared access repository
It seems so simple and obvious: Set up an electronic database that incorporates controls to assuage suppliers’ confidentiality concerns, and that allows suppliers to meet their extractables data reporting obligations. Such a database could allow end users to conduct their risk assessments and verify the suitability of any given container in their production operations.
Biopharmaceutical companies use this data to directly and confidently compare the quality and safety of products from different single-use manufacturers. This ultimately means that by selecting single-use manufacturers that closely align to BPOG guidelines, biopharmaceutical companies can have increased confidence that the products they select will be of the highest quality and purity, and therefore meet their process requirements.
Through its practice guidelines, the BPOG has enabled easier, more rapid, and more effective adoption of single-use products by stimulating collective industry discussions and providing common solutions. Easier access to the data generated to those guidelines should be a topic for the BPOG to address, using its collective and inclusive approach to identify a solution to this issue. Perhaps that solution already exists. The Extractables and Leachables Safety Information Exchange (ELSIE) seems the clear choice.
Single-use standardization: The way forward
Adherence to the BPOG common set of extractables testing method plays a key role in the drive toward greater standardization on single-use products across the biopharmaceutical industry. Greater standardization offers a multitude of benefits.
Today, the trend is toward standardizing on specific construction materials and complete single-use product configurations, which are created by identifying critical design attributes and combining them to develop a standardized system for use across all bioproduction processes. Standardizing on BPOG-compliant single-use products throughout an entire network of facilities offers biopharmaceutical companies additional control and consistency over their valuable sterile process liquids, driving high-quality, safe, and effective new vaccines and biologics.
Standardization also focuses on more streamlined, repeatable, and consistent processes that are easier and quicker to implement. This helps biopharmaceutical companies to comply with cGMP requirements, which stipulate the deployment of controlled procedures to increase the reliability of predicted outcomes.
The ever-increasing reliance of the biopharmaceutical industry on single-use products inevitably places strains on supply chains and lead times. Standardization can effectively address this challenge by optimizing procurement procedures and facilitating a sustainable model for the provision of single-use products. This strengthens the supply chain and allows for shorter delivery timelines, promoting an even more widespread adoption of single-use products.
Product efficacy and patient safety are utmost priorities for biopharmaceutical companies, which rely on single-use manufacturers to provide them with high-quality products to securely store sterile process liquids for use in vaccine and biologics production. To effectively meet the liquid processing needs of biopharmaceutical companies, single-use products must be manufactured using fit-for-purpose and well-characterized materials that have undergone extractables testing to a widely accepted standard. The BPOG best practices guides help standardize extractables testing, allowing for easy, direct comparison of construction materials and final single-use products, and driving well-informed decision-making. Although some challenges exist to improve access to that data, standardizing on BPOG-compliant single-use products benefits biopharmaceutical manufacturers through optimized bioprocessing operations, increased productivity, cGMP compliance, and an enhanced ability to deliver new products to market faster.
Donald Young is senior global product manager, Single-Use Technologies, Thermo Fisher Scientific.
- Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing. BioPhorum Extractables Workstream. April 2020.