Protein post-translational modification analysis services

The post-translational modifications of proteins are a major source of heterogeneity in recombinant proteins, monoclonal antibodies and other biotherapeutic products. Glycosylation, oxidation, deamidation, glycation, cleavage or disulfide bond variations can affect a product’s structure, biological activity, stability, safety and reproducibility. Monitoring them is therefore essential throughout development, during comparability studies, process transfer, batch characterization and deviation investigations.

Depending on the sequence, expression system and storage conditions, the Filab laboratory can focus the investigation on modifications such as oxidation of sensitive residues, deamidation, glycation, cleavage, disulfide bond formation or rearrangement, charge variants and certain forms of glycosylation. Peptide mapping makes it possible to locate detected modifications at the sequence level.

analysis may combine chromatographic separation, electrophoresis, molecular mass measurement and high-resolution mass spectrometry. LC-MS/MS approaches, including peptide mapping, provide information on peptide identity, the location of certain modifications and the comparison of their relative abundances. Intact protein analysis additionally helps assess the overall distribution of molecular forms.

Studying post-translational modifications is particularly relevant when scaling up, modifying the culture medium, changing the purification process, transferring production to another site or altering the formulation. It is also useful for investigating a trend observed during stability testing, an atypical result or a difference between batches.

The Filab laboratory develops protein analysis approaches based on your matrix, the level of product knowledge and the decision to be supported. The aim is to identify critical quality attributes, compare profiles between batches or stress conditions, and provide interpretable results for your development, production and quality control teams. This approach complements protein analysis services.

Comparing analytical profiles provides objective information for assessing the effect of a process, supplier, formulation, packaging or storage change. In particular, it can highlight relative changes in variants or the appearance of new species, helping to guide the additional investigations required.

An exploratory study can be implemented to quickly guide the investigation of a modification or compare samples. For more advanced requirements, the protocol can be adjusted to improve separation, sequence coverage, detection selectivity or data analysis. The analytical plan is defined with your technical contacts before the samples are received.

At the Filab laboratory, results are reported with a focus on comparison and decision support. Analytical data make it possible to document the similarities and differences observed between samples, identify signals requiring further investigation and define additional analysis where necessary. For raw materials or excipients associated with your formulations, services such as pharmaceutical ICP analysis can contribute to your characterization strategy.

Provide the available information on the protein, samples, formulation, expected comparisons, and study context. Specify the suspected modifications, previous results, and desired timeline. Discuss your needs with Filab laboratory to define an analytical strategy proportionate to your requirements, then receive an adapted protocol and quotation.