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why choose Chiralabs?

Biopharmaceuticals & biotechnology development


Chiralabs can offer a wide range of contract analysis and research involving biopharmaceuticals and biotechnology products regarding their molecular structure, interactions and robustness.  We have extensive experience of proteins, enzymes, glycoproteins, monoclonal antibodies (mAbs), and nucleic acids (DNA), including  biosimilars comparability and biotechnology development.  Typical investigations include:

  • Multi-spectroscopic-physicochemical fingerprinting (inc. circular dichroism, optical rotatory dispersion, uv-vis-NIR absorption, FT-IR, fluorescence, Raman,...) ;   - contact us for details of our comprehensive characterisation package for biotech products:  BioSpecXL TM 

  • Secondary structure & higher-order structure determinations & comparisons

  • Structural stability, denaturation & refolding characterisation

  • Temperature-stability and formulation-stability profiles

  • Ligand (drug) binding studies

  • Spectroscopic monitoring (Circular Dichroism a speciality)

  • Aggregation, association and precipitation monitoring

  • Structure-function, structure-property and spectral-property relationships

Such investigations can be employed across the research, development and production stages of biotechnology products, for example:

  • 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

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.