Introduction
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.
Our Services
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.
- Amino Acid Sequence
- Amino Acid Composition
- Terminal Amino Acid Aequence
- Peptide Mapping
- Sulfhydryl and Disulfide Bonds
- Carbohydrate
- Post-Translational Modification
- Complete Molecular Weight
- Peptide Mapping of Biosimilars
- Chromatography
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.
Key Features of Our Biopharmaceutical Characterization Services
- Free consultation and experimental design from our team of experienced experts.
- Sophisticated analytics platform and comprehensive technology coverage.
- Complete analytical services for biopharmaceuticals (protein/antibody/vaccine).
- Professional bioinformatics data analysis.
- Customized service.
- Perfect after-sales service.
Applications of Biopharmaceutical Characterization Services
- Protein/peptide Analysis
- Antibody Analysis
- Vaccine Analysis
- Analysis of PEGylated Proteins
- Glycan Analysis
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.
