Article | June 13, 2017

Biosimilar Analytical Similarity Assessments: Are You Testing Sufficient Innovator Lots?

Source: Sartorius

By Dr. Terry Gray, Bioanalytical Specialist, Sartorius Stedim BioOutsource

Analytical biosimilarity testing can be a controversial, complicated and uncertain topic. At BioOutsource, we recommend our clients take a stepwise orthogonal approach to aspects of analytical characterization combining structural, physiological, binding and biological data to provide a comprehensive, thorough and complete assessment of biosimilarity.

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