Among small molecule drugs, such as small RNAs, oligonucleotides, peptides or vaccines, recombinant proteins are the most commonly. The discovery and development of protein therapeutics is growing rapidly because of their cell-specific modality and relative lack of compound-specific toxicity, and soon will equal and even surpass chemical entity drug development.
By stringently monitoring both the manufacturing process over time and the finished product, drug manufacturers must ensure product consistency, quality, and purity. Therefore, to support and guide decisions made in developing the manufacturing process and product formulation of protein therapeutics, accurate and reproducible characterization methods are therefore an absolute requirement. A biologic must be "well-characterized" to assure its safety and efficacy. For protein pharmaceuticals, well-characterized means that the identity, heterogeneity, impurity, and potency can be defined with a high degree of confidence. Considering the complexity of the proteins, there is no one analytical platform or application that can meet all of these needs.
Fig1. ICH Guidelines for Protein Drug CharacterizationProtein characterization pose significant challenges. Most of the time, protein drugs are heterogeneous mixtures of closely related molecular weights and charged isoforms derived from living cells and usually include a complex pattern of product- and process-related impurities. What's more, recombinant proteins are complex: various post-translational modifications, a highly specific three-dimensional structure, and the potential for aggregation, adsorption, and truncation. The precise amino acid sequence, molecular weight, charge variances, glycosylation, aggregation level and oxidation level are all important components of thorough characterization of a protein drug.
In line with the ICH Q6B Guidance, Creative Proteomics offers protein analysis and characterization services including structure analysis, physicochemical properties, biological activity, immunochemical properties and purity and impurities determination to ensure the quality and consistency of your product. Creative Proteomics can fully characterize any protein biopharmaceuticals for the Chemistry and Manufacturing Controls (CMC) section of Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologic License Applications (BLAs). Protein drug characterization services available at Creative Proteomics are as below.
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