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Unlocking the Code to Precise Quantification of ADC Therapeutics: A Comprehensive Analysis of Cutting-Edge Technologies
SDM Bioservices has successfully established a hybrid immuno-capture LC-MS/MS platform for the simultaneous quantification of ADC total antibody, conjugated antibody, conjugated drug, and free small-molecule payload. This approach significantly reduces reliance on specific antibody reagents, enables rapid method development and validation, and supports high-throughput sample analysis—thereby accelerating project timelines and advancing drug development efforts.
ODAC Votes Against GSK's ADC Belantamab Mafodotin Combination Therapies
July 23, 2025 GSK disclosed that the FDA has postponed PDUFA date of the Blenrep® (belantamab mafodotin) combination therapy BLA. The agency established a new action date of October 23, 2025 for completion of BLA review.
SDM Sharing | Pre-IND Meeting Preparation Guidelines (China)
this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.
VIF 2025 REVIEW | Dr. Yuwen on Global Vaccine Registration Strategy and Key Considerations
Global Vaccine Solutions via Multidimensional Strategies.
