The Human protein case study

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.

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Superfine can micronize Proteins from human source with no degradation, at ambient conditions. PSD of d(0.9)=8 microns can be achieved.

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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.

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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.

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All techniques tried, such as jet milling, high pressure homogenization or micro-fluidization, failed to obtain the required quality due to product degradation.

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Superfine system was found to be suitable. Two units are installed in the company’s sterile manufacturing facility, manufacturing Fibrinogen on commercial scale.