Publications by authors named "Gustavo Grampp"

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Managing integrated continuous bioprocesses in real time: Deviations in product quality.
Gustavo Grampp, Allen Bosley, Maen Qadan, John Schiel, Andy Spasoff

Biotechnol Prog· April 2024

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Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study.
Robin Thorpe, Gustavo Grampp, Hye-Na Kang, Ivana Knezevic

Biologicals· November 2019

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Structure-Function Relationships for Recombinant Erythropoietins: A Case Study From a Proposed Manufacturing Change With Implications for Erythropoietin Biosimilar Study Designs.
Gustavo Grampp, Patricia L McElroy, Gary Camblin, Allan Pollock

J Pharm Sci· June 2018

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A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.
Stella Stergiopoulos, Carrie A Brown, Thomas Felix, Gustavo Grampp, Kenneth A Getz

Drug Saf· November 2016

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The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders.
Gustavo Grampp, Sundar Ramanan

BioDrugs· December 2015

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Study design is important for ESA biosimilars.
Allan Pollock, Gustavo Grampp

Nephrol News Issues· November 2015

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Pharmacovigilance Considerations for Biosimilars in the USA.
Gustavo Grampp, Thomas Felix

BioDrugs· October 2015

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Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins.
Stella Stergiopoulos, Carrie A Brown, Gustavo Grampp, Thomas Felix, Kenneth A Getz

Ther Innov Regul Sci· September 2015

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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Lawrence X Yu, Jeffrey Baker, Susan C Berlam, Ashley Boam, E J Brandreth, Gustavo Grampp

AAPS J· July 2015

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Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.
Gustavo Grampp, Machaon Bonafede, Thomas Felix, Edward Li, Michael Malecki

Expert Opin Drug Saf· March 2015

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Drift, evolution, and divergence in biologics and biosimilars manufacturing.
Sundar Ramanan, Gustavo Grampp

BioDrugs· August 2014

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Preventing shortages of biologic medicines.
Sundar Ramanan, Gustavo Grampp

Expert Rev Clin Pharmacol· March 2014

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Global regulatory standards for the approval of biosimilars.
Barbara Mounho, Audrey Phillips, Kay Holcombe, Gustavo Grampp, Tony Lubiniecki

Food Drug Law J· February 2014

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Managing unexpected events in the manufacturing of biologic medicines.
Gustavo Grampp, Sundar Ramanan

BioDrugs· August 2013

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Comparability and biosimilarity: considerations for the healthcare provider.
Jaymi F Lee, Jason B Litten, Gustavo Grampp

Curr Med Res Opin· June 2012

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Biosimilars 2.0: guiding principles for a global "patients first" standard.
Joseph Miletich, Geoffrey Eich, Gustavo Grampp, Barbara Mounho

MAbs· December 2011

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Sodium butyrate alters erythropoietin glycosylation via multiple mechanisms.
Christopher K Crowell, Qiang Qin, Gustavo E Grampp, Richard A Radcliffe, Gary N Rogers

Biotechnol Bioeng· January 2008

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Amino acid and manganese supplementation modulates the glycosylation state of erythropoietin in a CHO culture system.
Christopher K Crowell, Gustavo E Grampp, Gary N Rogers, Janis Miller, Robert I Scheinman

Biotechnol Bioeng· February 2007

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