Proteins And Peptides
Proteins and peptides are sensitive organic substances. For special dosage-forms they need to be micronized. However, using conventional size-reduction equipment results in product degradation.
Superfine can micronize Proteins from human source with no degradation, at ambient conditions. PSD of d(0.9)=8 microns can be achieved.
This capability came for the help of Omrix, while developing EVARREST®
EVARREST® is a flexible sealant patch embedded with human biologics and provides a durable mechanical structure for integrated clot formation.
The active ingredient in EVARREST® is Fibrinogen, a human protein that needs to be milled to 5-100 microns while maintaining at least 80% of its biological activity.
All techniques tried, such as jet milling, high pressure homogenization or micro-fluidization, failed to obtain the required quality due to product degradation.
Superfine system was found to be suitable. Two units are installed in the company’s sterile manufacturing facility, manufacturing Fibrinogen on commercial scale.