GE Healthcare is introducing Biacore T100 protein characterisation software version 2, to enable calibration-free concentration analysis (CFCA) of proteins
For the first time it will be possible to measure protein concentration without the need for a standard.
The new software also comprises key functionality for protein characterisation that reduces time spent on development of kinetic analysis assays through the single-cycle kinetics function.
Single-cycle kinetics enables the analysis of molecular interactions which have previously been difficult to determine.
In addition, data evaluation is significantly improved in the new software version and enables multiple samples to be analysed together with a few simple clicks, supported by inbuilt QC functions/tools.
Knowing the accurate concentration that relates to the specific binding activity of a protein is key for many applications.
Determination of the target-binding drug fraction is extremely important during the development of therapeutic proteins and provides a highly informative characterisation profile in quality control of biotherapeutics.
Resistentia Pharmaceuticals in Uppsala, Sweden, is developing immunotherapeutic products for allergic asthma and inflammatory disorders.
The company has developed a quantitative assay incorporating the Biacore T100 CFCA methodology for quantification of a therapeutic protein during development, and for implementation as a quality control assay at a CRO.
"Knowing the accurate concentration of a drug in early development and being able to relate this to specific binding activity is invaluable in the design and conduct of pre-clinical and clinical studies.
"Measurement of specific binding activity raises the possibility of optimising the production process of most biologicals and thereby increasing the proportion of active drug resulting in reduced COGS.
In addition, the safety of a biological drug product may be improved by reducing the amount of inactive substance" said Stefan Persson, VP toxicology, Resistentia.
"The assay is not only fast and reliable but also means that we don't need to depend on the performance of standards, and the sample consumption is very low so the need for scaling up of drug is minimised".
The Biacore T100 is used throughout the drug discovery and development process, from early research to QC.
There are currently several hundreds of units installed worldwide, in labs ranging from major pharmaceutical companies to academic research institutes.
