Biopharmaceutical Characterization Services
- Home
- Applications
- Biopharmaceutical Characterization Services
Service Details
Biopharmaceuticals are complex medicines made from living cells or organisms, often produced using cutting-edge biotechnology methods. They are proteins (including antibodies), nucleic acids (DNA, RNA, or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and produced by means other than direct extraction from natural (non-engineered) biological sources. However, due to the complex biological process and many influencing factors of biological products, new impurities may be introduced during the production process of biological products, or the structural properties of biological products may become inhomogeneous. These factors may weaken the efficacy of biological drugs, and even cause adverse results such as biological toxicity and immune response of the body. Therefore, biopharmaceuticals must undergo a series of strict tests before entering clinical trials to determine whether the biopharmaceuticals are compliant.
Structural and physicochemical characterization is an important part of biopharmaceutical evaluation. Creative Proteomics provides a variety of structural and physicochemical elemental analyzes covering biopharmaceuticals according to ICH Q6B guidelines, including but not limited to.
Based on high-resolution mass spectrometry technology, Creative Proteomics provides a series of complete biopharmaceutical characterization solutions, from amino acid composition and primary structure analysis of proteins, peptides, antibodies, vaccines and other biological products, to product variability and purity analysis.
Our goal is to provide high-quality biopharmaceutical identification and analysis services for global researchers, including but not limited to:
Biopharmaceutical Identification Analysis Services
According to the requirements of ICH Q6B guidelines, Creative Proteomics provides comprehensive biopharmaceutical identification and analysis services, including biopharmaceutical amino acid analysis, peptide mapping analysis, antibody epitope mapping, molecular weight determination and other services.
Biopharmaceutical Variation Analysis Services
The production process of biopharmaceuticals is accompanied by various modification problems, including oxidation, glycosylation, deamidation and mutation. With an advanced mass spectrometry platform, Creative Proteomics provides comprehensive analysis and characterization services for biopharmaceutical variants.
Biopharmaceutical Purity Analysis Services
Quantification of impurities in biopharmaceuticals directly affects efficacy, which can negatively impact the stability, safety, and efficacy of protein therapeutics. Creative Proteomics' biopharmaceutical purity assays will confirm the purity (i.e. identify any unwanted impurities) of your product, whether it is a peptide, protein or glycoprotein.
*Note: In addition to the above services, we can also provide customized services for other types of biological products and biopharmaceuticals. You are welcome to contact us for specific requirements related to these biopharmaceuticals.
Creative Proteomics has a dedicated team of bioscientists to provide a range of biopharmaceutical and bioinformatics analysis services to our clients. Thanks to our biological expertise and data analytics capabilities, we provide high-quality biopharmaceutical analysis solutions. Please contact us immediately If you are interested in our services.
For research use only, not intended for any clinical use.