Protein Aggregation Analyser

Particle Counting and Size Analysis has been a fundamental requirement for the US FDA to ensure the safety of injectable fluids and drugs. The objective of USP 788 is to ensure the particles present in such pharmaceutical preparations are less than 2 specified sizes of 10 and 20 microns. USP 788 requires that the measurement be performed with an instrument such as the Accusizer 780-SIS that uses SPOS (Single Particle Optical Sizing) . The 780-SIS can be used to measure and monitor the presence of protein dimers, immunogenicity or oligomerization, protein agglomeration and aggregation, protein clumping, native protein and aggregate proxy.
With the increasing development of protein drug injectables, the PSS model 780-SIS has been designed to accommodate a range of protein sample types with the fluidic path made of materials compatible with different sample types. This model also caters for new protein drug development where small valuable quantities of sample are only available. The 780-SIS can be programmed for small injections through the sensor but statistics are not compromised because the small sample can be repeatedly put through the sensor by the push-pull mechanism of the delivery system, building up the statistical numbers.
The small valuable sample can also be retrieved for further research.



Protein Aggregation Analyser
Protein Aggregation Analyser » Particle Sizing Systems - Protein Aggregation Analyser
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The difficulty of therapeutic proten production is monitoring their inst...