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BOC Sciences' assay center is equipped with advanced instruments to provide comprehensive biopharmaceutical analysis services in compliance with the FDA regulatory requirements. Our one-stop system supports the analysis and determination of Antibody-Drug Conjugates (ADCs), which determine drugs' biological activity and provide a series of standardized cellular and biochemical assays.
Certain antibody-conjugated drugs (ADCs) can be tested in the naked antibody stage, such as glycosylation structure, peptide map, charge heterogeneity, which is more accessible than the conjugated stage. For ADC development, selecting the appropriate quality control methods, quality control items and consumables based on the target attributes is an essential link in helping drugs move from theoretical design to laboratory preparation. In order to ensure the safety, efficiency and quality of the ADCs drug, the drug activity needs to be tested during the development stages, which is also one of the most critical indicators during the development process. Methods for viability detection include in vivo assays, in vitro animal organ assays, biochemical enzyme reaction assays, immunological activity assays and in vitro cell culture assays.
Cellular health plays a vital role in the screening of drugs. During the early stage of drug development, it was common to evaluate whether a drug could efficiently eliminate cell targets. BOC Sciences provides various methods to detect cell viability and cytotoxicity, including the stain exclusion method, fluorescence exclusion method, MTT colorimetric method, Annexin V/PI staining method, etc. In addition, we can also perform cellular health assays according to customer needs.
Drug effects testing is an important part of product quality control strategy for complex drugs. It is combined with the detection of physicochemical properties to ensure production consistency in the products life cycle. In general, the efficacy determination should reflect the mechanism of action of the products. For multifunctional products, more than one pharmacodynamic test is required to fully grasp its biological activity. BOC Sciences can provide drug effects testing services to evaluate ADCs through antigen binding assays and cell-based functional tests. We can use flow cytometry to test the cell cycle, discover specific drug effects to each cell cycle stage as well as study the overall drug effect toward the targets. Furthermore, high-resolution images can also be used to observe intracellular transport and co-localization.
Flow cytometry is a laser technique for detecting cell or particle properties. It is a powerful tool for rapid, quantitative and accurate determination of cell characteristics. BOC Sciences can track and locate the intracellular transport of drugs through flow cytometry and fluorescence microscopy. We can provide cell detection methods for development and validation to meet customers' regulatory requirements. We design tailor-made cell detection development solutions based on experimental processes and optimized customer-supplied analytical methods to enhance research.
| Quality Attributes | Test Item | Assay Methods |
| Identification | Peptide Mapping, Charge Heterogeneity, Immunoassay | RP-HPLC, cIEF & CE & IEX-HPLC, Western Blotting, ELISA |
| Glycan Profiling | Sialic Acid Content, N-Glycan Content | HILIC-UPLC, CE |
| Purity | Size Heterogeneity | CE-SDS, SEC-GPLC, SDS-PAG |
| Charge Heterogeneity | IEX-HPLC, cIEF, Zeta Potential/Nanosizer | |
| Product-Related Impurities | CE, LC-MS/MS | |
| Process-Related Impurities（Protein A, Host cell DNA, HCP） | ELISA, QPCR | |
| Potency | Bioassay, Binding Assay | Cell Assay, Antigen Binding ELISA, Biacore, Flow Cytometry |
| Content | Protein Concentration | UV, HPLC, BCA |
| Safety | Sterility, Bacterial Endotoxin, Abnormal Toxicity (USP-Acute Toxicity, EP-Undue Toxicity) | Purification by Filtration and Column, In Vivo Testing (Uses Mouse or Guinea Pig) |
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