Downstream Process & Formulation Chemicals
Chemicals used in the downstream processing and purification of biologics often have multiple functions that vary by application, complicating selection for manufacturers with specific quality or cost expectations. Our broad portfolio of downstream chemicals streamlines raw material specification with optimized quality attributes for the full range of downstream needs – then goes a step further by seamlessly integrating supply transparency, documentation, good manufacturing practice (GMP), and change control, all tailored to your risk assessments.
Raw materials within our industry-leading Emprove® chemicals portfolio are supported with comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve processes. The portfolio is divided into categories that reflect the specific application needs of drug manufacturers.
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Emprove® Chemicals Portfolio
- 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.
- For more information, visit our Emprove® Chemicals page.
mAb Processing Applications
Our broad range of downstream chemicals and buffers helps to guide your monoclonal antibody from upstream processing to the final fill. You will find compounds that perform a variety of functions, including mAb modification and stabilization.
Plasma Processes
Increasing yields and maintaining safety are major challenges in plasma processes. Our downstream chemicals provide the tools you need to run complex plasma-fractionation processes successfully, by maintaining process safety.
Vaccines and Gene Therapy
Vaccine and gene therapy manufacturers need to reach high yields, maintain product safety, and accelerate development timelines. Our proven portfolio of reliable and consistent chemicals and manufacturing enzymes such as Benzonase® endonuclease helps you cope with those challenges, supporting your vaccine and gene therapy processes from harvest throughout your entire downstream process.
Bacterial Fermentation Applications
Using microbial expression systems such as yeast and bacteria to manufacture simpler molecules offers reduced production cost and significantly higher upstream productivity. Our portfolio supports any step from the reactor to final product, including purification and modification.
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