Protein Stabilizers

Protein Stabilizers

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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, and amino acids 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

Increase 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”.

Click image to enlarge.

Sugars & Polyols	Amino Acids
103789 Sucrose EMPROVE® EXPERT	101544 L-Arginine monohydrochloride EMPROVE® EXPERT
111597 Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp	101587 L-Arginine EMPROVE® EXPERT
137096 D(-)-Mannitol EMPROVE® EXPERT	100590 Glycine cryst. EMPROVE® EXPERT
102776 Trehalose dihydrate EMPROVE® EXPERT	103669 Glycine granulated EMPROVE® EXPERT
137028 Glycerol EMPROVE® EXPERT	104352 L-Histidine EMPROVE® EXPERT
107430 L-Proline EMPROVE® EXPERT	104354 L-Histidine monohydrochloride monohydrate EMPROVE® EXPERT