Biopharmaceuticals & biotechnology development
Chiralabs can offer a wide range of studies involving biopharmaceuticals, biosimilars and biotechnology development, regarding molecular structure, interactions and robustness, including:
- Multi-spectroscopic-physicochemical fingerprinting
- Biosimilar comparisons, characterisation & analysis
- Validation and objective methods of comparing and interpreting spectra (for FDA submissions etc.)
- Quality Control method development
- Process Analytical Technology (PAT) development
- Optimisation of production conditions and envelope of variability
- Specification failure investigations and troubleshooting
- Formulation optimisation & comparisons
- Competitor product analysis & comparisons
- Product equivalence & acceptability methods
- Batch-to-batch comparisons
- Stability, reactivity & degradation characterisation & optimisation
- "Yellow-protein" characterisation
- Aggregation
- Spectroscopic monitoring (Circular Dichroism a speciality)
The experience of our scientists in biopharmaceutical characterisation and the design of multi-technique methodology applicable to biotechnological development and manufacturing is extensive. In particular, Chiralabs has pionereered multi-spectroscopic fingerprinting methods for biopharmaceutical analysis and biosimilar comparisons. Chiralabs has also developed quantitative objective methods of comparing spectroscopic data (including objective Circular Dichroism comparisons) for FDA submissions.