Ensuring the reliable identification and characterization of therapeutic proteins
Biological drugs, including recombinant proteins, monoclonal antibodies and peptides, require analytical characterization suited to their structural complexity. A sequence variation, post-translational modification or degradation can affect a product’s profile and make comparisons between batches, active substances or finished products more challenging.
Filab laboratory offers peptide fingerprinting and mass measurement services to support the identification, comparison and characterization of molecules of biopharmaceutical interest. These analysis can address development, investigation, analytical transfer or quality monitoring needs.
Addressing development and quality control challenges
Peptide fingerprinting services can be incorporated into biomolecule characterization studies, comparability assessments or deviation analysis. The protocol is defined according to the nature of the sample, the study objective, the available reference and the expected comparison criteria.
Filab laboratory works with quality, analytical development and R&D teams to establish the relevant parameters, including sample preparation, digestion, chromatographic separation, detection strategy and reporting of results.
Building an analytical strategy suited to the sample
Batch comparison is based on a harmonized protocol applied to both the samples and the reference. Digestion, separation and acquisition conditions are defined to obtain comparable data. The chromatographic profiles and peptide masses are then examined according to the agreed criteria.
This approach can be relevant for studying development batches, supporting a process change or documenting an investigation. To broaden the assessment to manufacturing parameters, Filab laboratory also offers an industrial process audit.
Why entrust your analysis to Filab laboratory
Filab laboratory supports biopharmaceutical companies in defining and conducting their analytical studies. The approach aims to connect business needs with a consistent technical strategy, from feasibility assessment through to reporting of results.
Preliminary discussions help clarify the nature of the samples, the information available, the comparison objective, the expected level of characterization and time constraints.
Dedicated analytical capabilities for peptide fingerprinting and mass measurement
Peptide fingerprinting is based on the controlled enzymatic digestion of a protein, followed by analysis of the resulting peptides. The peptide profile generated provides a basis for comparison between a sample and a reference defined as part of the study.
Mass spectrometry measures the molecular mass of an intact protein or peptides resulting from its digestion. Depending on the analytical objective, Filab laboratory uses liquid chromatography coupled with mass spectrometry, as well as high-resolution mass spectrometry (HRMS) analysis.
Analyzing intact proteins and peptides
The analysis can be performed at the intact protein level to observe its molecular mass, or after enzymatic digestion to study the peptide profile. The selected approach depends on the question being addressed and the level of information sought.
Chromatography and mass spectrometry data are interpreted in light of the defined analytical plan. Results are provided in a report tailored to the study’s needs.
Leveraging high-resolution mass spectrometry
High-resolution mass spectrometry enables precise measurement of mass-to-charge ratios and strengthens the ability to discriminate between peptide species with similar masses. It is particularly useful when characterization requires detailed mass information.
However, the choice of analytical conditions must remain consistent with the matrix, available concentrations, molecular complexity and project objective.
Obtaining actionable results for your project
Results are presented in a structured format to facilitate their use by project teams. The report may include operating conditions, analytical observations and the comparison elements defined within the scope of the study.
Filab laboratory adapts the level of reporting to the project’s requirements, whether for an exploratory study, an analytical investigation or development support.
Start your analytical study
To initiate a project, provide the available information about the molecule, matrix, samples and analytical objective. Filab laboratory will then be able to assess the request and define a suitable study proposal.
Describe your needs, discuss them with our teams and obtain a peptide or mass fingerprinting analysis strategy tailored to your project.