Information is crucial for drug manufacturers selecting filtration and single-use technologies. Answering the industry-wide demand for increasing levels of transparency, our expanded Emprove® Filter and Single-use Components portfolio now covers all the major steps of the biopharmaceutical process. So you can move forward in your product development with confidence.
If you have purchased an Emprove qualified product you can download all the dossiers that you need here.
If you have a Custom Mobius Assembly, the Advanced Qualification Dossier is customized with assembly specific information including regulatory information and USP <665> Extractables information.
The Advanced Qualification Dossier is customized with specific information for your assembly. The dossier can be purchase individually or subscribe to the Emprove® Suite
**Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing, BioPhorum, published April 2020 & USP <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, Finalized Nov 2021, Effective May 2026
All our high-quality portfolio products feature Emprove® Dossiers, providing the optimized information you need to fast track your drug to market. These include:
For an overview of our portfolio products and dossier availability, select any product family below.
*Status as per Q1 2023, constantly updated.
All polymeric components, such as the filters and single-use systems used in biopharmaceutical manufacturing, must be assessed for safety through an evaluation of extractables and potential leachables. Extractables are compounds that can be extracted from these materials, while leachables are compounds that leach from the materials into the process stream. An understanding of extractables is essential as it can help identify the leachables that may enter a process stream.
With our Emprove® Program, developing an extractables profile for filters and single-use systems no longer requires a time- and resource-intensive compilation of a vast amount of data. Instead, our Emprove® Operational Excellence Dossiers provide you with reliable extractables data based on industry standards and guidelines established by the BioPhorum Operations Group's (BPOG) standardized testing protocol and USP <665> chapters. The datasets generated facilitate your safety risk assessment, accelerating your ability to identify potential leachables and calculate patient exposure based on process conditions, total surface area in contact with the product, batch size and final drug product maximum daily dose.
Together with our BioReliance® Validation Services experts, we provide a higher level of confidence in safety risk assessment through careful selection of well-characterized materials, experience in identifying and analyzing potential leachables (or process-specific extractables) data, and expertise in the design and execution of need-based leachables studies. Because every product and process is unique, we tailor our approach to deliver best-in-class services and robust results that meet global industry standards, even as the standards continue to evolve.
For Mobius Assemblies that contain multiple components, the Advanced Qualification Dossier includes assembly and component information to support the qualification and patient safety. Included are the extractable datasets that are individually available through the Operational Excellence Dossiers (film, connectors, and filters) and Third-Party component Extractables Reports. To evaluate your specific product and process, further support through consultation and services from Validation Services are available. The Advanced Qualification Dossier or individual component Extractable reports can be obtained from the links below.
A thorough interpretation of the extractables datasets from our Operational Excellence Dossiers to your specific product and process can further be supported through consultation and services from Bioreliance® Validation Services. For an overview of available Operational Excellence Dossiers, select any product family below.
* P/N stands for part number. The indicated part numbers are generic for the family. Please replace your specific part numbers as applicable.
Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.
Take a seat: The Emprove® Suite is here to improve your risk assessment journey. This Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current: You can not only easily find, view and download Emprove® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove® Dossier download metrics and reports, and so much more.
Ultimately, a subscription to the Emprove® Suite empowers you to:
Webinar: Challenges Using Multiple Single-Use Systems: Functionality Versus Extractables and Leachables
Webinar: Process Equipment characterization – How Standardized Extractables Data Support E&L Risk Assessment
White paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems
Article: Aiding Material Qualification and Risk Assessment for Single-Use Biomanufacturing
Brochure: Enabling a more robust risk assessment
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