Your need : to ensure the quality and conformity of your products by controlling their protein composition
Proteomics analysis
Proteomic analysis is a cutting-edge method used to identify, characterize and quantify the proteins present in complex biological samples. These studies explore the proteome, i.e. all the proteins expressed in a cell, tissue or organism at a given time.
Composition, structure and quantification of proteins
A proteomic analysis provides data on :
Proteomics analysis for biopharmaceuticals
Proteomic analysis is essential to guarantee the quality, safety and efficacy of biotherapies such as recombinant proteins, monoclonal antibodies and vaccines.
Recombinant proteins, used in numerous treatments, require precise characterisation to verify their structure and detect any post-translational modifications. Monoclonal antibodies, essential in targeted therapies, require in-depth analysis to ensure their purity, stability and ability to interact correctly with biological targets. Finally, vaccines, whether protein- or nucleic acid-based, require proteomic validation to guarantee their efficacy and eliminate the risks associated with contaminants or structural variations.
Proteomics can be used to characterise post-translational modifications, ensure protein integrity and meet biopharmaceutical regulatory requirements.
Proteomic analysis to control biotherapies
For biosimilars, proteomic analysis ensures equivalence with the original products. For plasma-derived products, this analysis ensures the identification and quantification of critical proteins, while optimising manufacturing processes.
Proteomic analysis thus offers solutions for securing and optimising the development and production of these biotherapies.
The FILAB laboratory carries out your proteomics analysis for safe and effective biotherapies
The FILAB laboratory has the experience and specific analytical equipment to provide biopharmaceutical companies with tailor-made proteomics analysis support.
FAQ
Proteomics analysis is important for guaranteeing the quality, safety and efficacy of biotherapies. It is used to characterise therapeutic proteins (e.g. recombinant proteins, monoclonal antibodies) by detecting post-translational modifications, structural variations and possible degradation, in order to meet strict regulatory requirements and ensure product stability.
For biosimilars, proteomics analysis is essential to demonstrate their equivalence with reference products. It enables detailed comparison of protein profiles, identifying any differences and ensuring that biosimilars meet the same standards of quality, efficacy and safety as the original, in compliance with regulations.
In quality control, proteomics analysis is used to check the purity of batches, identify degraded or modified proteins and detect any contamination. These analyses ensure that each batch produced meets the defined specifications and avoid the risk of product rejection or recall.
Proteomics analysis can be used to optimise bioprocesses by identifying critical protein-related stages (e.g. aggregation, degradation). This helps to improve yields, reduce production costs and avoid interruptions due to quality problems. It is also essential for validating changes to manufacturing processes or raw materials.
For the cosmetics industry, proteomics analysis plays a key role in the identification and validation of biological actives, particularly bioactive peptides used in anti-ageing or moisturising formulations. Manufacturers need precise control to ensure that the biological mechanisms targeted by their products are effective, while guaranteeing the absence of contaminants or allergens in the formulations.
Proteomics analysis enables manufacturers in the biopharmaceutical sector to meet :
- Quality control and compliance: guarantee the integrity, stability and safety of therapeutic proteins while meeting strict regulatory requirements.
- Bioprocess optimisation: characterize key proteins to improve formulations and control critical stages in the manufacturing process.
- Contaminant detection: identify exogenous or trace proteins that could compromise the purity or efficacy of biotherapies.
