Biopharma analytical toolbox
Developing new analytical tools for biopharma characterisation
Expanding the analytical toolbox for biopharmaceutical characterisation
Biopharmaceuticals are highly complex molecules due to their large size and structural heterogeneity. Analytical characterisation of biopharmaceuticals can be challenging and a final drug substance can be composed of a mixture of variants that can have an impact on stability, function, efficacy and safety.
During product development and manufacturing the Critical Quality Attributes (CQAs) of the molecule need to be characterised in detail using a range of analytical tools, including properties such as:
- Post translational modifications, for example glycosylation
- Aggregation profiling through a range of sizes from soluble to visible particulates
- Charge related variants
- Structural heterogeneity
An input is a unique capability, service or method of support that was provided, such as equipment or expertise.
- Provided open access to CPI’s state-of-the-art bioprocessing facilities and analytical equipment
- Shared expert technical and industrial knowledge around the analysis of biopharmaceuticals
- Collaborated on publicly funded R&D projects
An output is the result of the work, such as an experimental finding, an actual product or a pilot demonstrator.
- Demonstration of a prototype for an improved platform for Hydrogen Deuterium Exchange (HDX) analysis
- Supported the development of a new analytical platform to allow a quantitative approach to Circular Dichroism (CD)
- Development of analytics for rapid and high throughput analysis of glycosylation
- Development and supply of aggregation standards
An outcome arises from implementing the outputs, for example, a profit, an investment, providing jobs or delivering societal benefits. Outcomes continue once an innovation has been implemented and deliver benefit every year.
- Acceleration and de-risking of a range of new analytical tools for biopharmaceutical characterisation
- Improved analytical characterisation of biotherapeutics will ultimately lead to improved safety for patients