Biopharmaceuticals analytical services
Our biopharmaceutical services cover the analysis, characterization, and evaluation of various molecules, such as proteins, antibodies, and peptides. We address challenges related to their identity, purity, quality, safety, and efficacy.
Characterization, analysis, and testing of biotherapeutic and biological products in the laboratory
Biotherapeutic and biological products are innovative and complex solutions that require special attention at every stage of development. Whether for the characterization of small molecules (examples: nitrosamines) or large molecules, our laboratory is equipped with the latest analytical technologies to meet the strictest quality and safety requirements.
Characterization of large molecules (large molecules):
We offer advanced expertise in the characterization of biotherapeutic products, including recombinant proteins. Our proven methods ensure a thorough understanding of their structure, stability, and efficacy. In addition, we handle the characterization of cell and gene therapy products, helping bring cutting-edge treatments to market.
With our expertise and state-of-the-art tools, we support you in the success of your projects by ensuring the quality, safety, and efficacy of your biotherapeutic products.
FILAB helps you evaluate testing procedures and acceptance criteria for all your biotherapeutic products (mAb, proteins, peptides) - ICH Q6B
Thanks to our expertise in LC-MS/MS, we provide accurate and reliable data for the characterization of your biomolecules. Our biopharmaceutical analysis focus specifically on the structure and composition of monoclonal antibodies, recombinant hormones, therapeutic enzymes, and proteins, making it possible to detect any post-translational modifications, impurities, or degradation.
protein analysis thus makes it possible to assess the stability, purity, and integrity of these biomolecules, ensuring their compliance with regulatory standards and their efficacy in biopharmaceutical applications.
Structural characterization and biomolecule confirmation
Peptide mapping/peptide mapping
Structure of carbohydrate (monosaccharide composition (neutral and amino monosaccharides, sialic acid, glycosylation sites of polypeptide chain)
Reduced forms (HC, LC, Fab, FC)
Thermal stability
Sulfhydryl groups and disulfide bridges
Monosaccharide analysis by fluorimeter and HPLC
Characterization of physicochemical properties
Thanks to these methods, we provide robust and detailed data on the size, mass, and optical properties of biomolecules, which are essential for their development, validation, and quality control.
Molecular weight and size (intact mass by LC-MS and GPC-Triple Detection)
Liquid chromatography models (charge variants by IEX-UV)
Solubility: critical concentration and solution stability
Chromatographic profiles: characteristic liquid fingerprint by IEX or SEC
Spectroscopic profiles (ultraviolet and visible absorption and FTIR characterization)
Isoelectric point (pI) measurement:protein net charge
Impurity Identification in Biopharmaceutical Products
The detection and characterization of impurities in biopharmaceutical products are essential to ensure their safety, efficacy, and compliance with regulatory standards such as ICH Q6B.
Truncated forms by LC-MS
Post-translational modifications (PTM) by LC-MS/MS
Detection and Quantification of HCP (Host Cell Protein)
Analysis of solvent and cell culture residues
Aggregates by GPC-Triple Detection
Impurity procedures (ICH Q3D guideline, E&L etc...)
Quantitative analysis of residual DNA
Extractables & Leachables (E&L study)
For the detection of process-related impurities, we offer specific tests such as the quantification of elemental impurities according to USP 233 and ICH Q3D, as well as extractables and leachables analysis (E&L). We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction processes.
Thanks to our state-of-the-art analytical tools, we guarantee accurate data that comply with industry standards, thereby ensuring the quality and safety of your biopharmaceutical products.
FAQ
Peptide mapping is a key technique in the characterization of biotherapeutics. It involves fragmenting proteins into peptides to analyze their amino acid sequence. Used throughout drug development, this method ensures protein integrity and purity, detecting modifications and impurities through advanced technologies such as LC-MS/MS.
ICH Q6B is an international guideline that establishes uniform specifications for the quality of biotechnology and biological products. This document provides specific principles for the characterization, purity, identity, quantity, and potency of proteins, polypeptides, and their derivatives. It also applies to the control of impurities, contaminants, and other critical parameters related to manufacturing processes. The goal of ICH Q6B is to ensure that new products meet the required quality standards for market authorization, while ensuring the safety and efficacy of biological treatments.
The DSC makes it possible to assess the thermal stability of biomolecules, particularly proteins, in order to ensure their integrity and effectiveness throughout the development and production cycle.
FAQ
Peptide mapping is a key technique in the characterization of biotherapeutics. It involves fragmenting proteins into peptides to analyze their amino acid sequence. Used throughout drug development, this method ensures protein integrity and purity, detecting modifications and impurities through advanced technologies such as LC-MS/MS.
ICH Q6B is an international guideline that establishes uniform specifications for the quality of biotechnology and biological products. This document provides specific principles for the characterization, purity, identity, quantity, and potency of proteins, polypeptides, and their derivatives. It also applies to the control of impurities, contaminants, and other critical parameters related to manufacturing processes. The goal of ICH Q6B is to ensure that new products meet the required quality standards for market authorization, while ensuring the safety and efficacy of biological treatments.
The DSC makes it possible to assess the thermal stability of biomolecules, particularly proteins, in order to ensure their integrity and effectiveness throughout the development and production cycle.
