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Protein Stabilizers


Protein StabilizerSterile 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”.

Standard mAb Process
Click image to enlarge.

Sugars & PolyolsAmino 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
  104354
L-Histidine monohydrochloride monohydrate EMPROVE® EXPERT