Analytical Tools for Process and Product Characterization

  title={Analytical Tools for Process and Product Characterization},
  author={Brent S. Kendrick and Greg Chrimes and Steven L. Cockrill and John Paul Gabrielson and K. K. Arthur and Brad D. Prater and Qiang Qin and Bing Zhang and Anurag Singh Rathore},
The Quality by Design paradigm demands an enhanced understanding of processes and products. Biotech therapeutic products, being complex molecules, require a robust analytical platform to serve as the foundation for commercialization activities such as the definition of critical quality attributes. This platform is generally a combination of orthogonal, high-resolution techniques that together provide definition to the product and the process. This article presents recent developments in four… CONTINUE READING

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