Search results for " HPLC"
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
Impurity Testing of Biologic Drug Products
…origin via techniques such as SEC–HPLC, hydrophobic interaction chromatography (HIC), ion-exchange HPLC, and isoelectric focusing (IEF) capillary electrophoresis. Process-related impurities and resid…
Article
Challenges in Analytical Method Development and Validation
This approach has the potential to significantly speed up analytical method development and result in HPLC methods that are more robust, and therefore, analytical transfer problems are reduced.
Dev…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
In a quaternary solvent system, different combinations of the salt gradient and pH are achieved automatically by programming the HPLC pumps to deliver solvents from four different solvent channels. Fi…
Article
QbD and PAT in Upstream and Downstream Processing
Our ability to measure and then take action, therefore, is quite challenged if the assay is not a real-time assay (such as HPLC).
Johanning (QAtor): CPPs in a typical downstream process involvi…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
Biopharma Advances Demand Specialized Expertise
With this in mind, substitution of HPLC for UPLC, rapid microbiological screening methods, and investment in automated approaches to complex analytical problems such as protein sequencing are now bein…
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Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Selectivity in Size Exclusion Chromatography (SEC): It’s Much More than Average Pore Diameter (Å)
Describing the pore of a size exclusion chromatography resin with a single number such as average pore diameter is an oversimplification. The formation of pores is dependent on complex combinations of…