Search results for "ICH Q6B" in Articles / App Notes
Article
Quality by design for biotechnology products—part 1
Product specifications can be proposed using a combination of approaches, consistent with the guidance in ICH Q6B (Figure 2).20 Where appropriate, certain attribute specifications are based on existin…
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…