Article CommentaryCommentary
Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652
Wen-Li Chung
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Jian Yin
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Steven Messick
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Miguel Saggu
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Kate Tschudi
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Ann Woys
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Rod Rahimi
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Marianne Azarias
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Connie Kong
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
Bruce Kabakoff
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.

References
- 1.International Conference for Harmonisation, Quality Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology. ICH Geneva, 2005.
- 2.↵
- Dawson R. M. C.,
- Elliot D. C.,
- Elliot W. H.,
- Jones K. M.
- 3.↵Sigma-Aldrich Buffer Reference Center. https://www.sigmaaldrich.com/life-science/core-bioreagents/biological-buffers/learning-center/buffer-reference-center.html.
- 4.↵
- Pack B. W.,
- Montgomery L. L.,
- Hetrick E. M.
- 5.↵
- Swartz T. E.,
- Yin J.,
- Patapoff T. W.,
- Horst T.,
- Skieresz S. M.,
- Leggett G.,
- Morgan C. J.,
- Rahimi K.,
- Marhoul J.,
- Kabakoff B.
- 6.↵
- Yin J.,
- Swartz T. E.,
- Zhang J.,
- Patapoff T. W.,
- Chen B.,
- Marhoul J.,
- Shih N.,
- Kabakoff B.,
- Rahimi K.
- 7.↵
- Sader M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 581-591; DOI: 10.5731/pdajpst.2019.010652
Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 581-591; DOI: 10.5731/pdajpst.2019.010652
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.