Biophysical Characterisation of Biologics

Biophysical characterisation of biologics, supporting protein development by applying UV, CD, NMR, FTIR, fluorescence, SEC-MALS, AUC, DLS and DSC
The biophysical characterisation of biologics plays an important role in the development of protein therapeutics such as or monoclonal antibodies or biosimilars. The biophysical behaviour of proteins can impact many aspects of biologic drug function, activity and stability. Biophysical analytical methods can, for example, help to monitor or confirm conformational integrity, the nature of the folded state of the protein and how the peptides associate to form higher order structures. Understanding the interactions between drug substance and excipients, which may potentially alter protein structure and therefore product stability, is important during formulation development, stability studies and comparability. Biophysical methods can also provide valuable information on protein degradation and aggregation of proteins in solution.
Our biologics biophysical characterisation team apply a wide range of techniques to interrogate the biophysical behaviour of your molecule. We examine a product's higher-order structure (HOS), including secondary and tertiary structure, aggregation, oligomerization and degradation of the drug substance. We deliver phase-specific biophysical programs. During pre-formulation, we study the proteins in the environment and behaviour in addition to protein forced degradation studies and to support formulation development we study proteins in the buffers and in the presence of additives/excipients of interest. To support IND or NDA submissions, we conduct biophysical characterisation studies that assess spectroscopic, thermodynamic and hydrodynamic properties.
Higher Order Structure Analysis
Our higher order structure biophysical programs include high-resolution methods such as multi-dimensional nuclear magnetic resonance (NMR) and other spectroscopic methods such as circular dichroism (CD), Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), second derivative ultraviolet absorbance spectroscopy (UV-vis) and intrinsic fluorescence.
Aggregation Biophysical Studies
Differential scanning calorimetry (DSC), analytical ultracentrifugation (AUC), and light scattering techniques (DLS, SEC-MALS) allow the study of non-covalent structural aspects of a protein and also study of aggregates or oligomer formation in solution.
Spectroscopic Profiles for Protein Characterisation (ICH Q6B)
To establish spectroscopic profiles to support protein characterisation physico-chemical programs we apply ultraviolet and visible absorption spectra, circular dichroism (CD), nuclear magnetic resonance (NMR), infrared (FTIR) or fluorescence spectroscopy.
Our expertise in biophysical characterisation can support your product development process. With expertise across a wide range of product types including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, oligonucleotides, glycoproteins and biosimilars we can apply a wide range of biophysical technologies to deliver efficient and detailed information. Our experts provide strong scientific and technical leadership coupled with project management and regulatory knowledge that drives your development programs forward. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality and regulatory standards.
Intrinsic fluorescence assays use the fluorescence emission by aromatic amino acids tryptophan, tyrosine or phenylalanine to provide information about the tertiary structure of a protein. Tryptophan fluorescence, in particular, is sensitive to the local environment around Tryptophan and can be used to monitor changes in the tertiary structure of a protein making it a very useful method for formulation development, stability or comparability studies.
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