Emprove® Chromatography—Reliable documentation for membranes and resins
Are you looking for complete information tailored to downstream needs to accelerate your process development, qualification, and risk management activities?
The Emprove® Chromatography portfolio is accompanied by comprehensive dossiers that support data-driven selection of the right chromatography resin or membrane, a streamlined downstream process qualification, and robust risk assessment.
Benefit from reliable information tailored to chromatography needs, including extractables profiles aligned with USP <665>, reference spectra, and validated analytical and sterilization methods, easily accessible through our online repository Emprove® Suite.
How can the Emprove® Chromatography portfolio support your risk management and regulatory needs?
Don’t let fragmented data slow your progress. The Emprove® Dossiers for the Emprove® Chromatography portfolio consolidate extensive information for faster, audit-ready risk management and confident decision-making. Benefit from:
Supporting both chromatography resins and membranes for a variety of applications.
24/7 access to reliable information including extractables according to USP<665>, reference spectrum, and stability information.
Ready-to-use data packages that support risk assessment, qualification, and regulatory requirements.
Reduce risk with industry-leading documentation including USP <665> extractables requirements
Ensuring plastic components used in pharmaceutical and biopharmaceutical manufacturing processes meet USP <665> is central to patient safety and regulatory approval. Qualification, risk assessment and regulatory submissions require robust extractables data, also referred to as process equipment-related leachables (PERLs). While USP chapters <665> and <1665> focus on chromatography columns, polymer-based chromatography resins and membranes carry the same risk. The Emprove® Chromatography portfolio provides extensive, USP-aligned extractable profiles data to reduce risk and accelerate your time to market.
Emprove® Chromatography portfolio: Overview
The Emprove® Chromatography portfolio consolidates critical regulatory, technical, and supplier information for chromatography membranes and resins, enabling faster, more reliable downstream development and qualification.
Tailored Emprove® Dossiers for chromatography membranes and resins
The Emprove® Dossiers are designed to provide exactly the information you need for your downstream process and are tailored to each product. This is why the information you receive for chromatography membranes and chromatography resins differs:
- For membranes, you will receive design and release criteria and testing along with expanded extractables information following both BioPhorum Extractables protocol and USP <665>.
- For resins, you can access reference spectrum, analytical procedures and stability information. Both come with essential information such as extractables profile, release criteria, regulatory statements, supply chain information, and more.
Explore our Emprove® Chromatography membranes and Chromatography resins products in the tabs above.
Emprove® Chromatography Membranes: Overview of products
We are continuously evolving our Emprove® Program which includes a continuous expansion of the products supported and the information provided. The above overview represents the Q4/2026 status.
We are continuously evolving our Emprove® Program which includes a continuous expansion of the products supported and the information provided. The above overview represents the Q4/2026 status.
Do you want to know which information you’ll get with the Emprove® Dossier? Download a free demo dossier.
Frequently asked questions
Which information can I find in the Emprove® Dossiers for chromatography materials?
The Emprove® Dossiers for chromatography materials provide the technical, regulatory, and supply information you need for your downstream process development, qualification, and risk assessment. They include extractables data aligned with USP <665> high-risk requirements, regulatory statements, test methods, release criteria, sterilization information, material-specific quality data, and more. This information is organized in three different dossier types that match ICH CTD Chapter 3 format to minimize the time and effort you have to invest to gather and organize data. For a sneak peek, download a Demo Dossier here.
How does the Emprove® Program ensure compliance with new regulatory developments like USP <665>?
The Emprove® Dossiers are maintained and constantly updated to reflect current industry trends, evolving standards, and new development in regulatory requirements. Customers can opt to receive notifications of updates via the Emprove® Suite, ensuring they always have access to the latest information for audits and submissions.
Which information is needed for qualification and risk assessment of chromatography purification steps and how can I access it?
Core data include extractables profiles, supply and manufacturing information, stability, analytical and sterilization methods, release criteria, and regulatory statements. This information is centralized in the Emprove® Dossiers and accessible anytime via the Emprove® Suite, enabling streamlined qualification and risk assessment. Register to access the Emprove® Suite here.
Related resources
- Article: Extractables and leachables risk assessment for single-use systems
Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).
- Article: Successfully navigate the regulatory landscape for chemicals and single-use consumables
This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
- Article: Reducing the need for animal testing for biological reactivity in polymer characterization
This page provides an overview of USP <87>, <88>, and <1031>, compares bioreactivity testing, and describes the transition of our organization towards in vitro test methods.
- White paper: A practical approach for determining extractables in chromatography resins in the light of the upcoming USP chapter <665>
Explore a practical approach to assessing chromatography resin extractables, that systematically examined chromatography resin bulk material and their risk profiles applying the USP <1665> risk assessment matrix and USP <665> requirements.
Related webinars
Assess chromatography resin extractables with an adapted USP <665> approach to strengthen risk assessments in biopharmaceutical manufacturing.
Address EU GMP Annex 1 challenges with proven strategies for single-use system qualification, testing, and risk mitigation.