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Research ArticleResearch

Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities

Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez and Adeyma Y. Arroyo
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 377-393; DOI: https://doi.org/10.5731/pdajpst.2019.010611
Pao Lin Che
1Pharmaceutical Processing and Technology Development;
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  • For correspondence: che.pauline@gene.com arroyo.adeyma@gene.com
Alison P. Bailey
2Protein Analytical Chemistry; and
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Chi Yan J. Tam
2Protein Analytical Chemistry; and
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Melissa Alvarez
2Protein Analytical Chemistry; and
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Adeyma Y. Arroyo
3Pharmaceutical Technical Innovation and Global Manufacturing Sciences, Genentech, Inc., a member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080
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  • For correspondence: che.pauline@gene.com arroyo.adeyma@gene.com
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References

  1. 1.↵
    Parenteral Drug Association Inc. Technical Report No. 29: Points to Consider for Cleaning Validation (Revised 2012); Bethesda, MD, 2012.
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    Parenteral Drug Association Inc. Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation; Bethesda, MD, 2010.
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    International Conference on Harmonisation, ICH Harmonised Tripartate Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH Geneva, 2000.
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    1. Liu H. F.,
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    Recovery and Purification Process Development for Monoclonal Antibody Production. MAbs 2010, 2 (5), 480–499.
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    1. Strauss D. M.,
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  11. 11.↵
    1. Kendrik K.,
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    Analysis of Degradation Properties of Biopharmaceutical Active Ingredients as Caused by Various Process Cleaning Agents and Temperature. J. Valid. Technol. 2009, 15 (3), 69–77.
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    1. Vlasak J.,
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    Fragmentation of Monoclonal Antibodies. MAbs 2011, 3 (3), 253–263.
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    Methodology for Assessing Product Inactivation during Cleaning. Part II: Setting Acceptance Limits of Biopharmaceutical Product Carryover for Equipment Cleaning. J. Valid. Technol. 2013, 19 (4), 1–8.
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    1. LeBlanc D.
    Issues in Setting Limits for Actives in Bulk Biotech Manufacture. J. Valid. Technol. 2009, 15 (1), 71–76.
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez, Adeyma Y. Arroyo
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 377-393; DOI: 10.5731/pdajpst.2019.010611

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Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities
Pao Lin Che, Alison P. Bailey, Chi Yan J. Tam, Melissa Alvarez, Adeyma Y. Arroyo
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 377-393; DOI: 10.5731/pdajpst.2019.010611
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Keywords

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  • Degraded protein clearance

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