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A general evidence-based sequence variant control limit for recombinant therapeutic protein development

Aming Zhanga Analytical Chemistry, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USACorrespondence[email protected]

Zhengwei Chena Analytical Chemistry, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA

Meinuo Lia Analytical Chemistry, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA

Haibo Qiua Analytical Chemistry, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USACorrespondence[email protected]

https://orcid.org/0000-0002-8449-4233

Shawn Lawrenceb Preclinical Manufacturing and Process Development, Tarrytown, New York, USA

Hanne Bakb Preclinical Manufacturing and Process Development, Tarrytown, New York, USA

Ning Lia Analytical Chemistry, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA

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Article: 1791399 | Received 18 Mar 2020, Accepted 08 Jun 2020, Published online: 02 Aug 2020

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https://doi.org/10.1080/19420862.2020.1791399
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