Introducing a new drug to the market is an extensive and intricate process. Development, testing, and registrations take years to complete, yet you must be ready for quick market launch by expediting approvals and maintaining reliable manufacturing processes at every step. Now you can confidently speed your way through the regulatory maze and fast track your new drug to market, with the Emprove® Program.
The Emprove® Program combines high-quality products, comprehensive documentation, and superior customer support to facilitate your efforts in qualification, risk assessment, and process optimization. It covers over 400 raw and starting materials, selected filter and single-use product families, chromatography resins, and cell culture media. These are the Emprove® product portfolios:
The Emprove® Program provides full supplier transparency at your fingertips, anticipating industry expectations not yet covered by regulation. Each product portfolio is supported with Emprove® Dossiers:
This combination of high-quality products and comprehensive, up-to-date documentation sets our Emprove® Program apart – helping you to navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Getting the information you need is even more convenient when you subscribe to our Emprove® Suite. Subscribers receive online access to all dossiers of the entire Emprove® portfolio, in a format that is constantly updated and optimized for targeted search. Key features include:
White Paper: Identifying Appropriate-quality Raw Materials in an Evolving Regulatory Environment
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
Risk Mitigation Tool: Support for Biomanufacturing Processes
White Paper: A practical approach for determining extractables in chromatography resins in the light of the upcoming USP chapter
New PDA/IPEC Technical Report on Excipient Risk Assessment – Insights for Drug Product Manufacturers
Challenges Using Multiple Single-use Systems – Functionality versus Extractables and Leachables
Process Equipment Characterization– How Standardized Extractables Data Support E&L Risk Assessment
Extractables Profiles for Chromatography Resins– Adapted Approach of Upcoming USP <665>
New Developments of Excipient Regulations in China
Nitrosamines– New Requirements to Evaluate Contamination Risks
The Emprove® Program – An Introduction Focusing on the Emprove® Suite and Emprove® Chemicals content
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow
Risk-Based Approach to Evaluate Nitrosamines and Elemental Impurities from Single-Use Component
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