Protein Stabilizers

Parenteral formulations using protein stabilizers

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.

High-quality Protein Stabilizers for Biomolecules

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:

  • Low endotoxin and microbial limits
  • Elemental Impurity Information according to ICH Q3D
  • Emprove® Program and documentation supporting risk assessment
  • Emprove® Expert GMP-grade products for high-risk applications

Do you want to increase your efficiency during your Downstream Process?

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”.

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High-Quality Stabilizers for Your Biomolecules” with glass vials & syringe
Flyer: High-Quality Stabilizers for Your Biomolecules

Browse the PDF flyer showcasing key features of our stabilizer portfolio

Low-in-Nanoparticulate-Impurities Sucrose for Biopharmaceutical Formulations
Article: Low-in-Nanoparticulate-Impurities Sucrose for Biopharmaceutical Formulations

Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations

Application of excipients in downstream processing to improve protein purification poster screenshot
Poster: Application of Excipients in Downstream Processing

Learn about the benefits on protein stability, chromatographic performance and viral inactivation

Protecting Protein Stability with a Novel Grade of Sucrose
Whitepaper: Protecting Protein Stability with a Novel Grade of Sucrose

Get insights on NPIs found in commercially available sucrose, their origin and impact on protein stability

Related Webinars

Improving Downstream Processing: Application of Excipients in DSP” & speaker information
Improving Downstream Processing: Application of Excipients in DSP

Learn about an innovative excipient screening approach simulating low pH stress conditions during protein A chromatography and virus inactivation.

Nanoparticulate Impurities in Excipients - A Threat to Protein Stability” & speaker information
Nanoparticulate Impurities in Excipients - A Threat to Protein Stability

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.

Web Tools

Formulation Product Finder
Quickly sort our excipients and API portfolio by dosage form, application, and many other parameters

Parenteral Process Guide
Find information on process design considerations at key steps of a parenteral process

Biopharmaceutical Application Guide
Explore products and services for mAb, vaccines, microbial, ADC, and plasma processes

Risk Mitigation Tool
Get guidance through the challenges and quality requirements of your bio-manufacturing process

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