A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products-Reference-Cited by-同舟云学术

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products

Published:2020-01 Issue:1 Volume:109 Page:830-844
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Hubert Mario,Yang Dennis T.,Kwok Stanley C.,Rios Anacelia,Das Tapan K.,Patel Ankit,Wuchner Klaus,Antochshuk Valentyn,Junge Friederike,Bou-Assaf George M.,Cao Shawn,Saggu Miguel,Montrond Luis,Afonina Nataliya,Kolhe Parag,Loladze Vakhtang,Narhi Linda

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference46 articles.

1. Drug pipeline: 1Q18;DeFrancesco;Nat Biotechnol,2018

2. THPdb: database of FDA-approved peptide and protein therapeutics;Usmani;PLoS One,2017

3. Spectroscopic methods for assessing the molecular origins of macroscopic solution properties of highly concentrated liquid protein solutions;Blaffert;Anal Biochem,2018

4. Protein aggregation: pathways, induction factors and analysis;Mahler;J Pharm Sci,2009

5. Protein particulate detection issues in biotherapeutics development - current status;Das;AAPS PharmSciTech,2012

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