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Sources

1.FDA.go/safety/recalls-market-withdawals-safety-alerts
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4. Aggregation and Particle Formation of Therapeutic Proteins in Contact with a Novel Fluoropolymer Surface Versus Siliconized Surfaces: Effects of Agitation in Vials and in Prefilled Syringes, Brandon M. Teska, Jeffery M. Brake, Gregory S Tronto, John F. Carpenter, J. Pharm Sci, 13 Apr 2016
5.Particles in Therapeutic Protein Formulations Part 1: Overview of Analytical Methods, Sara Zolls et all, Published online 08 Dec 2001 in Wiley Online Library DOI 10.1002/jps.23001
6.Industry Perspective on the Control of Visible Particles, Tapan Das, European Biopharmaceutical Enterprises Satellite Session CMC Strategy from Europe 2017, May22-24 Killarney< Ireland
7.Impact of Residual Impurities and Contaminants on Protein Stability, Wei Want, Arun Alphonse Ignatius, Satosh V. Thakkar, Wiley Periodicals, Inc. and the American Pharmacists Association Published by Elsevier 2014https://doi.org/10.1002/jps.23931

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John Rech

John Rech

Manager, Particle Tech, Lab

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