Biological Products Analysis Service
Drugs with biological origins are still the mainstream treatments for many diseases. These drugs include antibodies, recombinant proteins, vaccines, etc. With technological progression and expending demands, hundreds and thousands of new biopharmaceutical drugs have been developed each year. However, successful development of these drugs relies on ensuring the quality, potency, and safety of your biopharmaceutical product, as impurity and defection of these biopharmaceutical products may compromise the efficacy and place potential risks when applied in clinical stage. Therefore, evaluation of biopharmaceuticals is critical and necessary before clinical trials. To help solve the challenges in the developmental process of biopharmaceutical products, MtoZ Biolabs has established a comprehensive analytical platform for biopharmaceutical analysis, and is able to cover most biopharmaceutical related requirements. We strictly follow the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use.
Technical Platforms
Capillary Isoelectric Focusing
2D-DIGE
Size Exclusion Chromatography (SEC)
High Performance Liquid Chromatography (HPLC)
Reversed-Phase Chromatography (RP)
MALDI-TOF-MS/MS
ESI-TOF-MS/MS
Native MS
Hydrogen-Deuterium Exchange (HDX) MS
Identification of Biopharmaceuticals
Variation Analysis of Biopharmaceuticals
Purity Analysis of Biopharmaceuticals
*Apart from the above services, we can also provide customized service for other types of biologics and biopharmaceuticals. You are welcome to contact us for specific requirement related to these biopharmaceuticals.
Service Advantages
1. Free Consultation and Experimental Design
2. Well-Established Analytical Platform & Comprehensive Range of Technologies
3. Full-Package Service for Proteins/Antibody/Vaccines
4. Professional Data Analytical System
5. Support Custom Service
Applications
1. Antibody Analysis
2. Antibody-Drug-Conjugates (ADCs) Analysis
3. Protein/Peptide Analysis
4. Vaccines Analysis
5. PEGylated Proteins Analysis
6. Glycan Analysis
Related Services
Metabolomics
Quantitative Proteomics
Protein Analysis
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• Biopharmaceutical Impurities Analysis Service
Testing, identifying, quantifying, and controlling pharmaceutical impurities are crucial for ensuring the purity, safety, and quality of both drug substances and finished drug products. Pharmaceutical impurities originate from a variety too. This includes starting materials and their contaminants, reagents, catalysts, solvents, intermediates, excipients, leachables, and degradation products. These contaminants may be organic, related either to the process or the drug, or they could be inorganic o......
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• Charge Heterogeneity Analysis Service
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• Therapeutics Characterization Service | Advanced Structural
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• Primary Structure Analysis Service
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