Your need: ensure the quality and compliance of your products by mastering their proteomic composition
Proteomic analysis
Proteomic analysis is a cutting-edge method used to identify, characterize and quantify the proteins present in complex biological samples. These studies make it possible to explore the proteome, that is, the full set of proteins expressed in a cell, tissue or organism at a given time.
Protein composition, structure and quantification
Proteomic analysis provides data on:
Proteomic analysis for biopharmaceuticals
Proteomic analysis is essential to ensure the quality, safety, and efficacy of biotherapies such as recombinant proteins, monoclonal antibodies, and vaccines.
The recombinant proteins, used in many treatments, require precise characterization to verify their structure and detect any post-translational modifications.
The monoclonal antibodies, essential in targeted therapies, require in-depth analysis to ensure their purity, stability, and ability to interact properly with biological targets. Finally, vaccines, whether protein-based or nucleic acid-based, require proteomic validation to guarantee their efficacy and eliminate risks related to contaminants or structural variations.
It makes it possible to characterize post-translational modifications, ensure protein integrity, and meet regulatory requirements in biopharmaceutical.
Proteomic analysis to control biotherapies
For biosimilars, proteomic analysis helps ensure equivalence with originator products. For plasma-derived products, this analysis ensures the identification and quantification of critical proteins, while optimizing manufacturing processes.
Proteomic analysis therefore provides answers to secure and optimize the development and production of these biotherapies.
The FILAB laboratory carries out your proteomic analysis for safe and high-performance biotherapies
The FILAB laboratory has the experience and the analytical equipment needed to support biopharmaceutical companies with proteomic analysis through tailor-made support.
Our services for proteins
Peptide analysis and characterization (peptide mapping)
Our technical resources
FAQ
Proteomic analysis is important for ensuring the quality, safety, and efficacy of biotherapies. It makes it possible to characterize therapeutic proteins (e.g., recombinant proteins, monoclonal antibodies) by detecting post-translational modifications, structural variations, and any degradation, in order to meet strict regulatory requirements and ensure product stability.
For biosimilars, proteomic analysis is essential to demonstrate their equivalence with reference products. It makes it possible to compare protein profiles in detail, identify any differences, and ensure that biosimilars meet the same quality, efficacy, and safety standards as the original product, in accordance with regulations.
In quality control, proteomic analysis is used to verify batch purity, identify degraded or modified proteins, and detect any contamination. These analysis ensure that each produced batch meets the defined specifications and helps avoid the risk of product rejection or recalls.
Proteomic analysis helps optimize bioprocesses by identifying critical protein-related steps (e.g., aggregation, degradation). This contributes to improving yield, reducing production costs, and avoiding interruptions caused by quality issues. It is also essential for validating changes made to manufacturing processes or raw materials.
For the cosmetics industry, proteomic analysis plays a key role in identifying and validating biological actives, particularly bioactive peptides used in anti-aging or moisturizing formulations. Manufacturers need precise control to ensure that the biological mechanisms targeted by their products are effective, while also guaranteeing the absence of contaminants or allergens in the formulations.
Proteomic analysis enables companies in the biopharmaceutical sectors to address:
- Quality control and compliance : Ensuring the integrity, stability, and safety of therapeutic proteins while meeting strict regulatory requirements.
- Bioprocess optimization : Characterizing key proteins to refine formulations and control critical stages of manufacturing processes.
- Contaminant detection : Identifying exogenous or trace proteins that could compromise the purity or efficacy of biotherapies.
