Protheragen-ING Lab provides comprehensive solutions for the analysis of biologics, designed to offer professional analytical support to customers in the biomedical industry at all stages from research and development to manufacturing. Our services cover multiple aspects of biologics and are ready to help with the most complex projects.
Protheragen-ING Lab has assembled an experienced team of scientists in the field of biologics who can use cutting-edge instruments and techniques to identify and solve a wide range of analytical problems.
Find out more about each of our services
Protheragen-ING Lab performs analytical testing for all aspects of monoclonal antibodies, including analytical method development, raw material testing and stability services. Our services are dedicated to helping our clients ensure the safety, efficacy and quality of their monoclonal antibodies.
Protheragen-ING Lab's experienced team of experts uses industry-leading technology and equipment to analyze the size, purity, and impurity level of mRNA, as well as the raw materials of mRNA, and provides accurate results and test reports quickly.
Living Biotherapeutic Products (LBP) have the advantages of high safety, low cost, excellent efficacy and fast absorption compared to traditional chemical synthetic drugs. Protheragen-ING Lab provides turnkey services to characterize LBP to ensure the effectiveness and safety of the product.
Protein Characterization
Protein characterization is necessary for the development and manufacture of biological products. Protheragen-ING Lab provides one-stop protein analysis services, including all the important information for product development needs.
Everyone at Protheragen-ING Lab understands the importance of accuracy in protein characterization. We provide precise insight into the structural quality of the molecule to help our customers optimize protein potency and biological activity.
Primary Structure
- Peptide Mapping by LCMS and capillary electrophoresis (CE)
- Amino Acid Composition/Sequence LCMS, CE -N and C terminal sequence
- Intact Protein Molecular Weight By Size Exclusion Chromatography With Multi-Angle Light Scattering (SEC-MALS) or SDS PAGE Electrophoresis
- Protein Concentration by LCMS
- Isoelectric Point
- Spectroscopic Profile (FTIR)
Post Translational Modifications (LCMS, CE)
- Glycosylation/Sialyation (LCMS.CE.UPLC)
- Potency
- Binding by Enzyme Linked
- Immunosorbent Assays (ELISA), UV, Fluorescence And Luminescence
- Charge Heterogeneity
- Deamidation
- Di-Sulfide Bonds
- N-Acetylation
- Enzyme Activity Assays by Spectroscopy
- Phosphorylation
Impurities and Degradation Products
- Host Cell Proteins (ELISA)
- Host Cell DNA/RNA (qPCR)
- Aggregation
- Size exclusion chromatography with multi-angle light scattering (SEC-MALS)
- Zeta-Potential
Stability
- Thermal Stability by Differential Scanning Calorimetry (DSC)
- Photostability
- Freeze/Thaw Stability Shipping Studies
- ICH Long-Term Stability 5 ℃, -20 ℃, -80 ℃
Antibody Drug Conjugates/Peptide drug conjugates
- Drug-Antibody Ratio (DAR)
- Small Molecule Purity/Potency/Degradation (UPLC, LCMS)
- Linker analysis
Oligonucleotides
- Sequence (LCMS)
- Impurities (HILIC, IEX, LCMS, CE)
- Chain Length (CE)
- Molecular Mass (LCMS)
- Duplex formation (SEC)
Cell-Based Methods
- In vitro Potency
- USP <87>Biological Reactivity Tests, In vitro
- Proliferation Assays
- Neutralizing Antibody Assays
- Cytokine Assays
- Antibody Dependent Cytotoxicity
- Complement Dependent Cytotoxicity
Our Advantages
- Our team consists of scientists and engineers with deep biopharmaceutical backgrounds who have extensive experience in the field of biologics analysis.
- We used the latest analytical techniques, including mass spectrometry, nuclear magnetic resonance, circular dichroism, and high performance liquid chromatography, to ensure the accuracy and reliability of the analysis results.
- According to the specific needs of customers and product characteristics, we provide customized analysis solutions to meet the unique needs of different customers.
- Our quality management system follows international standards to ensure that every aspect of our analytical services is of the highest standard.
- We understand the urgency of biologics development and manufacturing and therefore provide rapid analytical services to support our clients' project schedules.
- Our services are not limited to a single test, but provide a comprehensive analysis solution from research and development to production.
- We provide continuous technical support and consulting services to our customers to help them solve challenges encountered in biologics analysis.
- We provide detailed data analysis and reporting services to help customers better understand test results and make decisions accordingly.
Contact us today to learn more about our biologics testing services or to inquire about customized testing solutions.