The development of antibody-drug conjugates (ADCs) poses challenges to bioanalysis because of their inherently intricate structures and potential for very complex catabolism. BOC Sciences, the leading ADC solution provider, proposes its integrated testing strategies for structure, purity, and impurities.
Bioanalytics
"We are intensely aware that precise structural confirmation, characterization, and quality control are the vital factors determining the success or failure of ADC drug development," the technical advisor of BOC Sciences said, "therefore, we've established an expert team specializing in the bioanalysis platform, expecting to provide cost-efficient solutions for our partners."
It's of great concern that biological analysis of ADC drugs is a daunting process because of their structural complexities, high similarities with biological macromolecules in bodies, upregulated heterogeneity, unexpected interference caused by internal metabolism's dynamic changes, etc. BOC Sciences bioanalysis research department finally worked through the hardship with its knowledge and experience. It has cultivated multiple ADC bioanalysis methods (UPLC and LC, LC-MS and LC-MS/MS, GC-MS, SEC...), among which the most appropriate one is carefully chosen for a specific ADC project.
Bioassays
BOC Sciences has also created an assay center equipped with cutting-edge instruments to provide biopharmaceutical analysis and determination of antibody-conjugated drugs. Its present bioassay package includes cellular health assays, drug effects detection, and cell detection. BOC Sciences can help verify the safety, efficiency, and quality of ADCs, which is an indispensable step to promote them from theoretical design to laboratory preparation and then to industrial production.
The advisor commented on the bioassay result acceptance, "we will prepare a detailed report for customers to learn about experimental steps, related MS parameters, original data, and ADC analysis results. It is designed concise as well as precise for customers' reference."
With decades of experience in small molecule bioanalysis and characterization, BOC Sciences has considerable knowledge of the evolving regulatory framework across different regions and the scientific background of this product class. From laboratory testing in GMP-compliant laboratories to regulatory compliance and beyond, BOC Sciences' ADC analysis and characterization expertise is delivered consistently with precision, pace, and passion, enabling the customers to power ahead safely.
Learn more about BOC Sciences' ADC technologies at https://adc.bocsci.com/.
About
Bringing quality and safety to life, BOC Sciences scientists engage with clients from all around the world, helping them to meet all regulatory expectations and specifications for successful ADC substance and ADC product release.