Newsletter | February 26, 2020

02.26.20 -- Do You Have The Right Tools To Determine CQA?

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing:
A Validated Measurement Process

Early prediction of potential implication on safety and efficacy is key to successfully launch a drug product on the market. Read on how GE Healthcare works closely with the biopharma industry to improve current workflows associated with discovery, development, and manufacturing quality control by providing various types of bioanalytical solutions support.

How Well Are Your HCP ELISAs Covered?

Validating host cell protein (HCP) ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE™ approach combines the best of existing methods.

Quantitating Binding Similarities In IgG Fc Receptor Analysis

Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how SPR has been applied for protein characterization of antibody effector function.

Better Biotherapeutic Characterization For Improved Quality Control
This booklet is a selection of scientific posters describing how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.
Selectivity In Size Exclusion Chromatography (SEC): It’s Much More Than Average Pore Diameter

Size exclusion chromatography (SEC) is currently the most powerful chromatography technique for obtaining reliable information about the size of biomolecules under native conditions. The formation of pores of a SEC resin is dependent on complex combinations of many parameters. Read more about all the parameters that affect resolution.


On-Demand Webinar On Immunogenicity Testing

Principles of immunogenicity using
Biacore™ T200 SPR system


The assessment of unwanted immunogenicity is a key parameter in the development process of biological protein drugs. Usually, ligand binding technologies such as ELISA are used for early immune responses, whereas SPR technology is utilized for the characterization of antibody isotypes, which may be important for the interpretation of the clinical consequences of unwanted immunogenicity.


View this webinar to learn when and how to use the SPR technology to obtain a deeper understanding of unwanted immunogenicity.