Sterile liquid applications demand excipients of the highest quality, purity, and reliability. Our comprehensive portfolio of high-quality pharmaceutical excipients offers everything you need for your medicinal drug product, backed by the regulatory and quality support of the Emprove® Program to streamline approval preparation and accelerate your processes. When your goal is a successful journey to market for small- or large-volume parenteral applications, you can count on our industry know-how, regulatory expertise, and comprehensive documentation to help you go forward with confidence.
Specifically developed for high-risk applications, our portfolio of high-quality sugars, polyols, amino acids, and surfactants simplifies selection when you face critical challenges such as preventing aggregation during manufacturing. Benefits include:
The production of antibodies and Fc-fusion proteins involves several downstream processing unit operations. The widely used purification template with Protein A chromatography, virus inactivation at low pH, and subsequent ion exchange chromatography steps is mostly able to remove impurities like aggregates, host-cell proteins, and viruses, which could affect the safety and efficacy of the product.
The low pH elution during Protein A chromatography, as well as during virus inactivation may induce aggregation. Preventing protein aggregation during these unit operations instead of removing the multimeric forms during subsequent polishing steps would be a more efficient strategy. Curious to learn more how the aggregation levels in the final product formulation can be minimized by excipients? Click on below image to check out our new Poster “Application of Excipients in Downstream Processing”.
Browse the PDF flyer showcasing key features of our stabilizer portfolio
Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations
Learn about the benefits on protein stability, chromatographic performance and viral inactivation
Get insights on NPIs found in commercially available sucrose, their origin and impact on protein stability
Learn about an innovative excipient screening approach simulating low pH stress conditions during protein A chromatography and virus inactivation.
Learn about the role of sucrose as a stabilizer in pharmaceuticals, the presence and characteristics of NPIs in pharmaceutical-grade sucrose, and their impact on protein stability.
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Parenteral Process Guide
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Biopharmaceutical Application Guide
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Risk Mitigation Tool
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