Upstream Process Chemicals
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. You can rely on our cell culture media, purification, and clean-in-place products for consistent performance at every stage, from research to commercial application. Equally important, you can trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
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Emprove® Chemicals for Quality and Regulatory Support
Controlled manufacturing processes, optimized quality attributes, and precise analytical specifications make our raw materials well-suited for commercial biopharma processing. Now they go even further to simplify your qualification and risk assessment, as part of our industry-leading Emprove® Chemicals portfolio. All raw and starting materials are organized into categories to streamline selection, with each product offering the comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
- Emprove® Evolve is for early stages of biopharmaceutical manufacturing, bridging the gap between lab-grade and GMP compliant raw and starting materials while providing transparent supply chain information and documentation.
- Emprove® Essential is for moderate-risk applications, offering compliance to IPEC-PQG GMP Guide and/or EXCiPACT™ Certification Standard, as well as supply chain transparency and regulatory support designed to assist drug manufacturers’ formalized risk assessments.
- Emprove® Expert is for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance. Along with the risk management features of Emprove® Essential, the Emprove® Expert line yields products with specified low microbiological and endotoxin levels, supporting the overall risk mitigation strategy.
Bulk Powder Transfer Bags for Safer, Faster Processing
To help you meet increasing industry demands for faster, more flexible bioprocessing, we can supply raw materials in pre-filled bulk powder transfer bags of 1–100 kg for operations of every scale. Bags are pre-weighed to within +/-0.5% accuracy, eliminating potential for error and connecting directly to your receiving vessel for mitigation of risks associated with contamination and employee safety. This service is one of many examples that set us apart as a partner committed to your process efficiency and quality, offering potential to eliminate labor-intensive steps such as rinsing, re-weighing, and cleanup from your buffer and media prep.
Highlights
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