Process-Related Impurity Testing
Our Process-related impurity analysis of biotherapeutics includes
- Host Cell Proteins (HCP)
- Protein A and culture impurities
- Detection and characterisation of subvisible particles and protein aggregates in protein therapeutics using Flow Cytometry:
- Size estimation of particles by using size calibration beads
- Quantification of particles
- Differentiation of proteinaceous and non-proteinaceous particles
- Characterisation of protein sub-visible particles (determination of cross-β-sheet structures)
Hot Cell Proteins (HCP)
Detecting impurities in time
Process-related impurity analysis is a critical aspect of biotherapeutic development and quality control. HCPs are an important class of impurities in biotherapeutics, and their quantification and characterisation is essential to ensure product safety and efficacy. This requires highly sensitive and specific methods, including HCP analysis using techniques such as enzyme-linked immunosorbent assays (ELISA) and mass spectrometry.
We offer state-of-the-art HCP analysis services as part of our comprehensive process-related impurity analysis capabilities to support the development and manufacturing of safe and effective biotherapeutics.
Contact us today to learn more about our process-related impurity analysis services and how we can support your project.
Protein Aggregate Characterisation
Modern equipment to detect and quantify particles down to the submicron range
Protein aggregates and subvisible particles can have a significant impact on the immunogenicity of protein therapeutics, potentially leading to adverse effects in patients. The characterisation of these particles is therefore a critical aspect of drug development.
We offer a flow cytometry-based assay for the characterisation of protein aggregates and subvisible particles in protein therapeutics. Our assay can detect and quantify particles down to the submicron range, providing valuable information about the size, shape, and distribution of these particles.
Our team of experienced scientists can work with you to develop and validate a customised assay that meets your specific needs and regulatory requirements. We can also provide consulting services to help you interpret your results and optimise your drug development strategy.
Contact us today to learn more about our flow cytometry-based assay for the characterisation of protein aggregates and subvisible particles, and how we can support your drug development programmes. With our expertise and state-of-the-art technology, we can help you to mitigate the potential immunogenicity of your protein therapeutics and improve patient safety.
