Our company can provide bioanalysis services for macromolecular drugs that comply with FDA/CFDA GLP standards. This supports the screening and development of protein drugs, antibody drugs, vaccines, and biomarkers, as well as preclinical and clinical research.
Service Overview
Our company has an independent macromolecule bioanalysis platform and a biotechnology drug analysis platform. We flexibly use ELISA, ECL, IP, Co-IP, qPCR, FACS, Elspot, enzymology, and other methods to support cutting-edge biological drugs, including proteins and antibodies (monoclonal antibodies, bispecific or multispecific antibodies, antibody fragments), early development and preclinical and clinical research of ADC, peptide, nucleic acid, vaccine, and cell gene therapy drugs. We develop and validate assays for different targets and support PK/TK/immunogenicity (total ADA, Nab)/biomarker/cytokine analysis.
Our company's laboratory implements comprehensive information management. We have established a complete sample management chain and experimental data processing, tracking, and storage chain. Our data is guaranteed to be accepted by FDA and CFDA, and we provide biotechnology drug analysis services that fully comply with FDA/CFDA/OECD GLP regulations.
Research Capabilities
Our research capabilities include but are not limited to the following:
Supporting Large Molecule Bioanalysis Using LC-MS
We have been offering technology for the measurement of proteins in biological matrices utilizing our LC-MS capabilities. The separation of macromolecules from related endogenous components in biological samples presents significant difficulty in the LC-MS study of macromolecules.
For the purpose of achieving the appropriate level of sample purity and sensitivity, we have a great deal of experience with a range of extraction and purification processes. For each of your unique projects, we suggest and create robust analytical workflows using either top-down comprehensive analysis or bottom-up proteolytic digestion.
LC-MS/MS Bioanalysis of Peptides
Using LC-MS/MS, we have developed and validated a method for measuring peptide levels in plasma down to 10 pg/mL. When performing extraction or LC-MS/MS measurements, poor binding to labware is frequently caused by the amino acid makeup of peptides or by their unique binding to other patterns. Our team has experience quickly predicting/diagnosing these problems and putting solutions in place to offer a trustworthy approach.
Due to the presence of a variety of endogenous peptidases, peptides can frequently be broken down quickly. We have a lot of expertise evaluating their stability, so we can give our customers advice on how to handle this scenario using pre-analytical stabilizing approaches.
Fig.1 LC-MS/MS analysis of a peptide with a molecular weight of 1616.68 Da. (Sokolowska I, et al. 2013)
Overall Solutions
| Project Name | Macromolecular Drug Bioanalysis Service |
| Service Details | - Development of immunoassay methods and methodological verification
- Analysis of proteins, antibodies, ADCs, peptide drugs, vaccines, cell and gene therapy products, etc.
- Screening and analysis of biomarkers, cytokine detection
- Drug resistance antibody (ADA) immunogenicity test
- Clinical sample bioanalysis
(1) Macromolecule bioanalysis method development and methodological confirmation;
(2) Develop, transfer, optimize, and validate immunoassay methods for the determination of drug concentration in biological matrices
(3) Developed, validated, and optimized immunoassays such as Bevacizumab, Trastuzumab, Pertuzumab, and antibody-drug conjugates
(4) Our macromolecular biology laboratory can quickly and efficiently complete methodological verification in a short time to support the needs of potential projects - Protein, antibody, peptide, and drug analysis
(1) Global clinical and preclinical trials
(2) Pharmacokinetics, toxicity, and immunogenicity tests
(3) Bioequivalence test - Vaccine analysis
(1) Monovalent and multivalent vaccine testing
(2) Multiple serotype antibody detection
(3)
High throughput automation technology
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| Deliverables | Within agreed time, we will provide the summary to experiment data and conclusions, as well as a final experiment report. |
| Cycle | Decide according to your needs. |
If you want to know more about service prices or technical details, please feel free to contact us.
Reference
- Sokolowska I, et al. (2013). "Applications of Mass Spectrometry in Proteomics." Australian Journal of Chemistry. 66(7): 721-733.
It should be noted that our service is only used for research, not for clinical use.
