Particle Identification and Characterisation by Multi-Technique Methods
Posted on June 14, 2016
By: Jonas Hoeg Thygesen, PhD., Research Scientist
Søren Flygenring Basset, PhD., R&D Director
Peter Ifversen, PhD., Associate Manager
Novo Nordisk Pharmatech
Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from ...
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Related Topics and Keywords
Characterisation, enumration, FDA Guidance, Immunogenicity Assessment, injectable protein formulations, Jonas Hoeg Thygesen, light microscope, Multi-Technique Methods, Novo Nordisk Pharmatech, optical, Particle Identification, particulate matter, protein aggregates in biologics, Size and Distribution, Size and Morphology, Søren Flygenring Basset, subvisible particles, Therapeutic Protein Products, United States Pharmacopia Chapter 1787
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