Antibody drug conjugates (ADCs) remain an important oncology therapeutic modality. ADC analyses require complex bioanalytical strategies to ensure complete pharmacokinetic and immunogenicity data is accurately reported which include both LBA and LC-MS/MS technologies.
KCAS has supported multiple Antibody Drug Conjugate (ADC) studies both in the Pharmaceutical and Biopharmaceutical divisions. Our regulated departments have been involved in non-clinical and clinical studies up to and including Phase 3 studies. We are able to respond quickly to regulatory agency inquiries regarding the analytical methodology used to assist you in your data package submission.
KCAS has integrated, on-site research divisions that can work together and streamline the complexities of ADC analyses to deliver reliable, defendable data on time. We have the scientific expertise and equipment to develop and validate both the LC-MS/MS based methods as well as the LBA based methods to successfully support your Antibody Drug Conjugate (ADC) program .