Case Studies

Our infrared process

Spectralys helps you solve your complex challenges from structural characterization and glycan analysis to in-process monitoring. Our team is eager to apply their experience on a broad range of molecules – including proteins, peptides, monoclonal antibodies, proteoliposomes, virus-like particles, vaccines and cells – on your specific project.

Spectralys provides best-in-class FTIR spectroscopy services such as:

  • Analytical services in its fully equipped laboratory in the centre of Europe,
  • Custom assay development,
  • Technical transfer to implement methods on-site
  • Coaching of customer staff to implement your analytical labs,
  • Advisory services on the analysis and interpretation of your data

In recent years, virus-like particles (VLP) emerged as an advanced vaccine platform providing safety and efficacy. VLPs are composed of self-assembling viral proteins that are able to mimic the morphology of native virions. However, the characterisation of VLP preparations remains a challenge, given the large size, diversity and complexity of the VLPs. Fourier transform infrared spectroscopy (FTIR) spectroscopy can be used as a tool to monitor the quality control of VLP-based vaccine.

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Glycosylation is the most common protein post-translational modification (PTM), especially in biopharmaceuticals. It is a critical quality attribute as it impacts product solubility, stability, half-life, pharmacokinetics and pharmacodynamics (PK/PD), bioactivity and safety (e.g. immunogenicity). Yet, current glycan analysis methods involve multiple and lengthy sample preparation steps which can affect the robustness of the analyses. The development of orthogonal, direct and simple method is therefore desirable.

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Glycosylation is the most common protein post-translational modification (PTM), especially in biopharmaceuticals. It is a critical quality attribute as it impacts product solubility, stability, half-life, pharmacokinetics and pharmacodynamics (PK/PD), bioactivity and safety (e.g. immunogenicity). Yet, current glycan analysis methods involve multiple and lengthy sample preparation steps which can affect the robustness of the analyses. The development of orthogonal, direct and simple method is therefore desirable.

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Tween 20 and 80 are commonly used in biotherapeutics formulations due to their low toxicity and good biocompatibility. However, their quantification still represents an analytical challenge. Based on our expertise in FTIR spectroscopy, we developed a methodology to detect and quantify Tween in biopharmaceutical products. The first figure shows a series of spectra of a therapeutic protein containing different levels of Tween 20. The spectral variations related to the increasing Tween concentrations can be clearly noticed on this figure.

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As many biologic drugs patents fall into the public domain, the development of biosimilars shows a growing interest in the pharmaceutical sector. However, biosimilar such as all biomolecules are very complex to characterize and very sensitive to minor manufacturing conditions changes compared to generic small molecules. Therefore, certifying the comparability of biosimilar candidates to the reference product regarding the quality, safety and efficacy requires a large panel of methods.

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The 1H / 2H exchange kinetic monitored by FTIR spectroscopy provide information related to the conformation of proteins. Indeed, the exchange rate depends on the stability of the secondary structure and on the accessibility of the peptide bond to the aqueous environment. It is an efficient way to compare the tertiary structure of proteins in several experimental conditions.

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Colloidal aluminium salts such as aluminum hydroxide are routinely used to improve immunogenicity of antigens. No general rule could be established as how adsorption affects protein conformation. According to the physicochemical properties of the antigen, the stability of this antigen may decrease or increase upon adsorption onto aluminium containing adjuvant. The analysis of the protein in the adsorbed state is thus crucial but its evaluation is still very challenging notably due to the scattering properties of the adjuvant. Most of the methods currently used require a desorption step. Based on our expertise in FTIR spectroscopy, we developed a methodology to […]

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