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BOC Sciences bioanalysis service department has a professional research team and analysis laboratory equipped with advanced instruments, as well as implemented with comprehensive information management to meet the FDA/CFDAGLP standards requirements. Our services cover pharmacokinetics, pharmacodynamics, immunogenicity and bioequivalence; we provide antibody-drug conjugates (ADCs) drugs screening and development services, as well as preclinical and clinical research to support our customers.
The accelerated approval of ADC drugs was beneficial from advanced technologies, including antibody engineering and conjugation technology. Furthermore, this enhancing progress has also stimulated the industry's passion for ADC drug-related research and development. But what follows next is the implementation of novel requirements toward the various technical means for the research and development. The biological analysis of ADC drugs confronts multiple obstacles, which include high structural complexity of ADC drugs; high similarities with biological macromolecules in bodies; upregulated heterogeneity; interference due to internal metabolism's dynamic changes; and requirement of high sensitivity technique in detection of free drugs. Thus, choosing the most suitable quality control technology has become essential for ADC drug development and quality analysis. In ADC drug development, structural confirmation, characterization and quality control are crucially linked to the accuracy, sensitivity and selectivity of a successful ADC drug. Based on these learnings, BOC Sciences equipped state-of-the-art analytical and preparative UPLC and LC instruments to provide our clients with the most comprehensive analytical services.
| Characterization | Test Items | Assay Methods | |
| Drug Conditions | MW (Sugar Loss) | LC-MS (Da) | |
| Conjugation Site Analysis | LC-MS/MS | ||
| Mean Conjugation Rate | LC-MS/MS, HIC-HPLC, RP-HPLC | ||
| Drug Distribution | LC-MS/MS, HIC-HPLC, RP-HPLC, CE-SDS | ||
| DAR Analysis | Relative Content of Different pl | cIEF | |
| Charge Isomer Distribution | CEX-HPLC (%) | ||
| CZE | CZE (min) |
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