Sequences from several different categories are available including functional genes (F), Our experts are ready to support your mAb product development and production, helping you to meet all of your monoclonal antibody analysis and characterization needs and according to the EMA and ICH guidelines.All IMGT germline databases are from IMGT/V-QUEST reference directory sets. Our experience spans recombinant monoclonal antibodies and related products such as bispecifics, biosimilars, fusion proteins, Fab-fragments and Fc fragments and antibody drug conjugates (ADCs). These charge heterogeneity methods can also be validated and used in quality control for monitoring this CQA as part of a batch release requirement. To establish overall levels of charge variants, we use CE or IEF techniques. During characterization, we apply our knowledge to determine the PTM profile, establishing the location of variants through peptide mapping with high resolution mass spectrometry. Recombinant mAbs undergo chemical degradation through diverse mechanisms comprising deamidation, oxidation, isomerization, and fragmentation that result in several charge variants and heterogeneity formation. To monitor aggregation, we use Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC), SEC-MALS, Dynamic Light Scattering (DLS) and Western Blot. Protein aggregation and fragmentation may lead to immunogenicity or loss of biological activity and our team use a variety of analytical approaches to address product variant or degradants.
Our state-of-the-art laboratories for custom antibody benefit from continuous investment in advanced analytical instrumentation, which allows us to deliver data with the highest sensitivity, accuracy, and resolution. Our team also profile post-translational modification hot spots through peptide mapping and monitoring areas such as the complementary determining region (CDR) which are important for specificity and so modifications in these regions are more likely to impact on activity. This allows expected sequences to be confirmed and terminal amino acid homogeneity to be assessed. Mass spectrometry is a powerful technique for confirming the primary sequence with intact mass analysis and peptide mapping. Physicochemical properties (includes colour, clarity / opalescence, pH, particulates, turbidity, extractable volume, moisture, osmolality) comms.Quantification of host cell proteins (HCP) - total or individual HCPs and residual DNA.Aggregation studies (SEC, DLS, Western Blot).Evaluation of PTMs including oxidation and deamidation (Mass spectrometry, cIEF).Terminal amino acid sequencing including lysine clipping, proline amidation, pyroglutamic acid.Disulphide bridge mapping (Mass spectrometry).Spectroscopic profile (CD, NMR, FTIR, Fluorescence) for secondary and higher order structure.Liquid chromatographic patterns (RP-HPLC, Ion Exchange HPLC, SEC).Electrophoretic and isoform patterns (cIEF, gel IEF, SDS PAGE, Western Blot, CZE).Extinction coefficient determination and validation.Amino acid sequence and composition (peptide mapping, mass spectrometry, amino acid analysis).Intact molecular weight (MW) and MW distribution (mass spectrometry, SEC-MALS).
We offer comprehensive antibody and mAb characterization and analysis services: Our antibody product ICH stability studies include forced degradation studies for identification of degradation products and development of stability indicating methods.
ANTIBODY SEQUENCE ANALYSIS TRIAL
We also offer support analytics to help you to demonstrate consistency or comparability of manufactured batches or as release tests for clinical trial materials or on-going GMP batch release tests. These analytics can be tailored to address your specific needs throughout development and the production and product lifecycle with a focus on monitoring relevant critical quality attributes (CQAs), to demonstrate that process changes do not impact physicochemical properties and structure, the presence of product-related impurities or process-related impurities. Monographs) to design strategic packages pertinent to your need and phase of development from preclinical-phase characterization studies through to Good Manufacturing Practice (cGMP) manufacture and beyond. With our high level of expertise in antibody and mAb analysis and characterization, we apply our experience, industry, and regulatory knowledge (in particular EMA and ICH guidelines, Ph. Expert support services in the analysis and characterization of antibodies and mAbs
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