Join Our On-Line ‘Book Club’ Panel Discussion: Thurs. August 22nd @ 2:00pm ET

Topic: Development of A New SEC-HPLC Method to Eliminate the Interactions of Proteins or Peptides with Residual Silanols and Improve the Separation of Proteins, Peptides and Impurities

Discussion (download entire PDF here): 
This article includes case studies and a discussion of CuriRx’s development of new SEC-HPLC methods to eliminate the interaction of proteins or peptides with residual silanols and improve the separation of proteins, peptides, and impurities of those biologics.

For the separation of biologics, the pharmaceutical industry uses Size Exclusion High Performance (SEC- HPLC) Columns to assess the major peaks, aggregates and degradants present in a product.
For the studies referenced in this article, many conditions and additives were evaluated including high ionic strength, organic solvents and ion pairing agents. Several SEC-HPLC columns and mobile phases were evaluated for the assay of proteins and peptides to further diminish interactions with residual silanols. Mobile phase optimization was evaluated based on plates, resolution, symmetry, recovery, RT closer to the real molecular weight and purity and impurity recovery.

This article will include a discussion for developing a denovo method to eliminate the interactions of proteins or peptides with residual silanols and improve the separation of proteins, peptides and impurities. CuriRx’s approach mitigates the problems associated with the recovery of the monomeric and high molecular species for these biomolecules, which are retarded or bound on the column during separation. Examples of peptides and antibodies will be presented that demonstrated reduced column interaction with full recovery of the monomeric and the aggregate species.