Analysis & Testing
ATONEST®Analysis and Testing Services
In biopharmaceuticals, various analytical procedures for drugs are the most critical basis for their approval and successful market entry. To meet clients' needs for biopharmaceutical analytical testing, leveraging extensive release testing experience, Aton announces the launch of the ATONEST®analysisand testing service platform.
With the addition of the ATONEST® analysis and testing service platform, Aton combines industry-leading manufacturing technology with robust analytical testing capabilities, elevating itself to provide a one-stop solution for cell line construction, analytical methods development, process development, IND submission, clinical sample manufacture, BLA/NDA submission, to commercial production testing, thereby empowering clients more comprehensively in new drug research and development.
With the addition of the ATONEST® analysis and testing service platform, Aton combines industry-leading manufacturing technology with robust analytical testing capabilities, elevating itself to provide a one-stop solution for cell line construction, analytical methods development, process development, IND submission, clinical sample manufacture, BLA/NDA submission, to commercial production testing, thereby empowering clients more comprehensively in new drug research and development.
Service Modules
ATONEST®Service Modules
ATONEST®Service List
The ATONEST®analysis and testing service platform encompasses seven categories, including research and characterization-related testing, stability testing & storage, antibody & ADC in-process and release testing, microbiological & environmental & water testing, biological activity testing, raw materials & packaging materials testing, and elemental impurities characterization (ICH Q3D).
More than 180 testing and analysis
With 70+ INDs, 10+ NDAs/BLAs, and in the testing and release of 750+ commercial batches, we provide clients with professional, high-quality testing reports that meet international standards and comply with CNAS requirements. We are also continuously expanding our range of analysis and testing services to meet increasing market demands.
Seven Testing Categories
R&D and Characterization Related Tests
Primary Structure, Higher Order Structure, Glycoforms Analysis, Immunization Characteristics Analysis, Extinction Coefficient, Characterization of Impurities
Stability Testing & Storage
Stability study, Stability Storage
Antibody & ADC In-process and Release Testing
Release Methods for Antibodies (mAb, BsAb), Fused Proteins, ADC Naked Antibodies, Bacteriostatic Water for Injection, etc.: Compendial Methods, Non-Compendial Methods, UPB Testing, ADC-Related Testing
Microbiological & Environmental & Water Testing
Microbial and Environmental Monitoring, Compendial Water Quality Testing, Compressed Air Monitoring
Biological Activity Testing
Molecular Testing (qPCR platform), Elisa Platform Testing, and Other Tests Related to Biological Activity
Raw Materials & Packaging Materials Testing
Raw Material Testing (according to Chinese, US, and EU Compendial Standards), Packaging Material Testing (according to National Standards)
Elemental Impurities Characterization (ICH Q3D)