A monoclonal antibody is a type of antibody that is produced in a laboratory by cloning a single type of immune cell. It is a highly specific and targeted protein that is designed to recognize and bind to a specific antigen or molecule in the body. Monoclonal antibodies are used in a variety of medical applications, including cancer treatment, autoimmune disorders, and infectious diseases. They can be used alone or in combination with other therapies to enhance their effectiveness.
Monoclonal antibody product characterization is critical for ensuring the safety and efficacy of the product and for regulatory approval. It is also essential for establishing the quality control standards and manufacturing processes of the product to ensure consistency and reproducibility. Monoclonal antibody product characterization involves the analysis and evaluation of specific characteristics of a monoclonal antibody (mAb) product, which includes a comprehensive set of tests, including physicochemical, biological, and functional assays, to determine the product's identity, purity, potency, stability, and immunogenicity. Physicochemical characterization involves analyzing the physical and chemical properties of the mAb product, such as its molecular weight, isoelectric point, glycosylation pattern, and charge heterogeneity. Biological characterization involves evaluating the product's biological activity, such as its binding affinity, specificity, and potency. Functional characterization involves assessing the product's ability to elicit the desired biological response and its potential side effects in vivo.
ALL Chemistry Inc. offers comprehensive antibody and mAb characterization and analysis services:
Specificity: To determine the specificity of the antibody and the target antigen. This helps to ensure that the antibody is binding to the target of interest and not to other molecules.
Potency: The potency of the monoclonal antibody is determined by the binding affinity to the target antigen. Characterization helps to assess the binding affinity and the concentration of the antibody required to achieve a therapeutic effect.
Purity: To ensure that the monoclonal antibody is pure and free of contaminants such as host cell proteins, endotoxins, and viruses.
Stability: Monoclonal antibodies can be sensitive to changes in pH, temperature, and other environmental factors. Characterization helps to assess the stability of the antibody under different conditions.
Safety: To assess the potential for immunogenicity and other safety concerns associated with the monoclonal antibody. This is particularly important for therapeutic antibodies that are administered to patients.
Our Capabilities:
MW and MW distribution (mass spectrometry, SEC-MALS)
Amino acid sequence and composition (peptide mapping, mass spectrometry, amino acid analysis)
Glycan profiling (HILIC-FLR-MS)
Extinction coefficient determination and validation
Electrophoretic and isoform patterns (cIEF, gel IEF, SDS PAGE, Western Blot, CZE)
Liquid chromatographic patterns (RP-HPLC, Ion Exchange HPLC, SEC)
Spectroscopic profile (CD, NMR, FTIR, Fluorescence) for secondary and higher order structure
Disulphide bridge mapping (Mass spectrometry)
Terminal amino acid sequencing including lysine clipping, proline amidation, pyroglutamic acid. (Mass spectrometry, CE)
Evaluation of PTMs including oxidation and deamidation (Mass spectrometry, cIEF)
Potency assessment (cell based assays)
Aggregation studies (SEC, DLS, Western Blot)
Forced degradation studies
Quantification of host cell proteins (HCP) - total or individual HCPs and residual DNA
Physicochemical properties (includes colour, clarity / opalescence, pH, particulates, turbidity, extractable volume, moisture, osmolality) comms
+1 609 531 0668
info@all-chemistry.com
STE 104 Marlton , NJ 08053, USA