Antibody-Drug Conjugates Development: GMP & GLP Testing
GMP and GLP Services
Wolfe Laboratories’ integrated translational drug development services enable a seamless transition from analytical and drug product development to preclinical and clinical studies in a manner compliant with regulations and industry standards.
Drug Substance and Drug Product
Wolfe Laboratories provides stage-appropriate development, qualification and validation of analytical methods, characterization and release testing of drug substance and drug product, and stability testing in a GMP- and GLP-compliant environment. Wolfe Laboratories supports GMP manufacturing by performing analytical and process technology transfer to one of its manufacturing collaborators or to a manufacturer selected by the client and by providing project management, in-process, release and stability testing as required.
Preclinical and Clinical Samples
Wolfe Laboratories provides GLP bioanalytical services for testing of biological samples from preclinical and clinical studies, including stage-appropriate LC-MS/MS method development and validation, testing of biological samples, incurred sample reanalysis (ISR) and long-term storage stability assessment.