Biopharmaceuticals mainly include proteins, peptides, monoclonal antibodies, nucleic acids, etc. They are currently used to treat major diseases such as oncology, AIDS, diabetes, cardiovascular and cerebrovascular diseases in clinical. Generally speaking, biopharmaceuticals are treatments with high efficiency and fewer side effects than traditional therapeutics. Although biopharmaceuticals are highly safe, they can cause an immune response and lead to systemic immune effects such as allergies. The related side effects often depend on the applied dose of the therapeutic drug. In order to correctly evaluate the efficacy and safety of various biological drugs in the human body, it is necessary to study the pharmacokinetics of the drugs in the body to provide a basis for individualized treatment. Therefore, it is essential to select quantitative assays with high specificity, sensitivity, and reproducibility in order to accurately evaluate the efficacy and safety of biological drugs in vivo.
The determination of protein quantity (concentration) is an important test procedure for biopharmaceutical products, as detailed in the relevant specifications from the International Conference on Harmonisation (ICH). Various methods for determining protein quantity are available currently, with the choice of assay depending on protein preparation, quantity available, and required throughput.
Amino Acid Analysis
The amino acid analysis is one of the most commonly used methods to characterize and quantify biopharmaceuticals. Our amino acid analysis service can be used to quantify specific amounts of purified proteins and peptides, which can also be used to determine the total protein concentration in complex samples.
Intact Proteins or Peptides Analysis
Liquid chromatography-mass spectrometry (LC-MS) techniques have been used in traditional methods for the bioanalysis of small-molecule drugs, protein, and ligand binding analysis. However, due to the higher selectivity, specificity, and dynamic range of mass spectrometry, LC-MS-based analysis has become an alternative method for quantitative analysis of biological drugs.
Our Protein Quantification Services for Biopharmaceuticals
Based on the in-depth understanding of the physical and chemical properties of proteins and amino acids, creative proteomics, as an expert in the field of biopharmaceuticals, provides protein quantitative determination services to accelerate your drug development. We use state-of-the-art technology and the latest workflow solutions from sample digestion to peptide and protein quantification.
➢ Amino Acid Analysis Service
➢ Extinction Coefficient Determination Service
➢ MALDI-TOF-MS Intact Protein Analysis
➢ ESI-MS Intact Protein Analysis
- Comprehensive set of technologies (instruments, columns, databases, methods, etc.) ensures that every element of the protein analysis is reliably determined
- Accurate quantitative analysis
- Fast turnaround time
- Customized exclusive solutions
- Reliable protein digestion and purification strategies
- High resolution, sensitivity and throughput
- J. E. Noble Æ A. E. Knight Æ A. J. Reason Æ A. Di Matola Æ M. J. A. Bailey. A Comparison of Protein Quantitation Assays for Biopharmaceutical Applications. Mol Biotechnol (2007) 37:99–111.