Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses

Jinshu Qiu; Kim Li; Karen Miller; Anil Raghani

doi:10.5731/pdajpst.2015.01056

Article CommentaryCommentary

Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses

Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

Jinshu Qiu

1Product Development, Amgen Inc., Thousand Oaks, CA USA; and

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For correspondence: jqiu@amgen.com araghani@amgen.com

Kim Li

2Environment, Health, Safety and Sustainability, Amgen Inc., Thousand Oaks, CA USA

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Karen Miller

1Product Development, Amgen Inc., Thousand Oaks, CA USA; and

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Anil Raghani

1Product Development, Amgen Inc., Thousand Oaks, CA USA; and

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For correspondence: jqiu@amgen.com araghani@amgen.com

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vol. 69 no. 3 334-345

DOI

https://doi.org/10.5731/pdajpst.2015.01056

PubMed

26048741

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 4, 2015.

Author Information

Jinshu Qiu1,*,
Kim Li2,
Karen Miller1 and
Anil Raghani1,*

¹Product Development, Amgen Inc., Thousand Oaks, CA USA; and
²Environment, Health, Safety and Sustainability, Amgen Inc., Thousand Oaks, CA USA

↵*Corresponding Authors: jqiu{at}amgen.com, 805-447-3183; araghani{at}amgen.com, 805-447-0668.

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Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses

Jinshu Qiu, Kim Li, Karen Miller, Anil Raghani

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: 10.5731/pdajpst.2015.01056

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Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses

Jinshu Qiu, Kim Li, Karen Miller, Anil Raghani

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: 10.5731/pdajpst.2015.01056

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Keywords

Clearance testing strategy
Process reagents
Process-related impurity
Safety margin
GRAS reagents
PSC reagents

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