BOC Sciences bioanalysis service department has a professional scientific research team, the analysis laboratory is equipped with advanced instruments and equipment, and comprehensive information management is implemented. The experimental research meets the requirements of FDA/CFDAGLP standards. The service covers pharmacokinetics, pharmacodynamics, immunogenicity and bioequivalence, and provides customers with screening and development of Antibody-Drug Conjugates (ADCs) drugs, as well as preclinical and clinical research.

ADC has both the specificity of large-molecule drugs and the cytotoxicity of small-molecule drugs, and ADC need to bioquantitate their antibody and small-molecule drug components during the development process. ELISA and LC-MS/MS methods have become common bioanalytical techniques for ADC analysis. Traditionally, the in vivo quantitative analysis of biological macromolecules uses the ELISA method, and small molecule drugs use the LC-MS/MS method. In the process of ADC drug development, structural confirmation, characterization, and quality control are all important links, which must be as accurate, sensitive and selective as possible.

Bioanalytics services provided by BOC Sciences include

• DAR value determination (HIC, LC-MS, RP-HPLC)
• Conjugation site confirmation (HIC)
• Determination of free small molecules (determining drug loading)
• Purity assessment (gel electrophoresis, molecular sieve (SEC) high performance liquid chromatography)
• ADC serum stability (immunology, chromatography, etc.)
• ADC drug release kinetics (optical, chromatography, isotope, etc.)
• Quantification of residual unbound drug (HPLC, LC-MS)

The current methods that BOC Sciences can use for bioanalytics include

• Analytical and preparatory UPLC and LC
• LC-MS and LC-MS / MS for small and large molecules
• GC-MS (headspace analysis)
• All types of chromatography (Size-exclusion/gel-filtration chromatography SEC, reversed phase RP, hydrophobic interaction chromatography HIC, Hydrophobic interaction liquid chromatography HILIC, Ion exchange chromatography IEX, chiral separations)
• 1D-NMR analysis
• 2-D NMR analysis

BOC Sciences is equipped with a series of state-of-the-art analytical and preparative UPLC and LC instruments. We can provide our clients with a very comprehensive analysis service.

Our advantages

• True loyalty and partnership
• Skilled chemistry team
• Fully equipped analytical support
• High quality, low cost products
• Advanced technology and methods
• Comprehensive analysis of biopharmaceutical services