The step-wise framework to design a chromatography-based hydrophobicity assay for viral particles

Author:

Johnson Sarah A.,Walsh Alison,Brown Matthew R.,Lute Scott C.,Roush David J.,Burnham Michael S.,Brorson Kurt A.

Funder

FDA/CDER/OBP

Oak Ridge Institute for Science and Education

DoE

FDA

Regulatory Science & Review Enhancement Program (RSR)

Research Review Coordinating Committee(RRCC)

Publisher

Elsevier BV

Subject

Cell Biology,Clinical Biochemistry,Biochemistry,General Medicine,Analytical Chemistry

Reference41 articles.

1. Evolution of approaches to viral safety issues for biological products;Lubiniecki;PDA J. Pharm. Sci. Technol.,2011

2. ICH Harmonised Tripartite Guideline: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines Of Human Or Animal Origin Q5A (R1);International Conference on Harmonsation (ICH),1999

3. Binding mechanisms of viral clearance utilizing multimodal anion exchange chromatography;Brown,2015

4. A step-wise approach to define binding mechanisms of surrogate viral particles to multi-modal anion exchange resin in a single solute system;Brown;Biotechnol. Bioeng.,2017

5. Salt effects on hydrophobic interactions in precipitation and chromatography of proteins: an interpretation of the lyotropic series;Melander;Arch. Biochem. Biophys.,1977

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