December 6, 2016
11am EST to 12pm EST

Sponsored by

Webinar Description:

Improved Methods for Host Cell Protein Analysis. A comprehensive analysis of HCP impurities requires the integration of data from orthogonal methods with the sensitivity to analyze those HCPs that actually co-purify with the product. While ELISA is the gold standard and will likely remain as the release test, qualification of the ELISA and validation of purification processes necessitate implementation of orthogonal methods with the sensitivity to detect and identify individual HCPs. This talk will discuss how methods like Antibody Affinity Extraction and Mass spectrometry can be combined with sound ELISA development to achieve a more complete analysis of HCP content than has been traditionally required by regulatory agencies.

Learning Objectives:

• Overcome common mistakes in HCP Antibody and Assay development
• Learn about Antibody Affinity Extraction - a method much superior to 2D Western blot
• When, where, and how to integrate Mass spectrometry data to identify individual HCPs

Speaker:

Kenneth L. Hoffman, M.S.

President of Cygnus Technologies, Inc.

Cygnus Technologies
Ken Hoffman founded Cygnus Technologies in 1996 with a focus on developing analytical methods for detection of impurities in biopharmaceuticals. With an MS in Raditation biology/health physics and immunology from the University of Iowa he worked for 20 years in R&D developing clinical diagnostic assays and automated laboratory testing systems for several companies in the fields of cancer, infectious diseases, metabolic disorders, and therapeutic drugs and drugs of abuse. In the 20 years since its founding, Cygnus Technologies has continually innovated and remained a leader in the field of bioprocess impurity testing. Cygnus sells its state of the art products and services to every biopharmaceutical company in the world.