We offer analytical services for all biomolecules based on our expertise in FTIR spectroscopy. For therapeutic proteins, we can assess the following parameters:
- Higher order structure (HOS) – including aggregation
- Post-translational modifications (PTMs): quantification of glycosylation and phosphorylation patterns
- Quantification of key excipients such as buffer components (Tween), residual solvents, stabilizing agents, antifoam agents (PPG, PEG, silicone oil) or lipids
- Absolute protein concentration
These parameters can be monitored simultaneously in a precise, quick and direct manner (a couple of minutes), with limited sample volume (<50µg) and without need for separation methods or extensive sample pre-treatment.
We can perform the analyses at our lab and record the results in a structured report or calibrate and transfer the method to your production site, ensuring real-time in-process information about key characteristics of the produced therapeutic proteins.
Please find below a non-exhaustive list of possible applications:
- In Research phases:
- Comparison of various expression systems
- Early stage screening of biosimilar candidates
- In Development phases (Characterisation and (Pre-)Formulation):
- Long-term stability and stress studies (temperature, pH and freeze-thaw cycle stress tests)
- Screening of various buffers and formulations
- Direct detection and absolute quantification of different types of glycosylations (sucrose, mannose, glucose,…)
- Characterization of higher order structure in high protein concentration formulations
- Structural characterization and stability studies of protein adsorbed onto aluminium-containing adjuvant
- Quality check of proteins embedded in lipid bilayers including analysis of protein structure (aggregation) and lipid composition
- In Process Development and Scale-up phases:
- Impact analysis of various process steps or production methods/parameters on key attributes of produced protein
- Compatibility studies of packaging containers/plastics
- Detection and quantification of Tween residues
- Detection and quantification of non-proteic residues
- Detection and quantification of lipids
- In production phases:
- At-line multi-parametric batch consistency testing
- Assistance to decision-making (i.e., identification of optimal time to interrupt cell cultures)
- Quality control of biological raw materials for diagnosis assays
- Protein concentration measurements
Case studies are currently being developed and will be available upon request.
