ELISPOT Assays Offer Unique Qualification for Cytokine-Based Immune Monitoring and Standardization Strategies.
Strategies for reducing drug attrition rates in the clinic through the application of transgenic ADME-Tox rodent models.
Antibody drug conjugates (ADCs) link precisely targeted antibodies to cytotoxic small molecule drugs with the goal of improving both the safety and efficacy of chemotherapeutics. Pivotal clinical trials of trastuzumab‐DM1 for women with treatment resistant HER2‐positive breast cancer and of SGN‐35 for relapsed/refractory Hodgkin's lymphoma represent the vanguard of several dozen ADCs currently in various stages of clinical development. According to Fred Regnier, Purdue University's John H. Law Distinguished Professor of Chemistry, Principal Investigator for the Purdue/IU Analytical Proteomics Team, and founder of Perfinity Biosciences, "The emergence of new isolation methods paired with stable isotope coding and mass spectrometry measurement of proteins, modified proteins, and their tryptic digests provides an unprecedented level of specificity and quantification in examining their structure, relative activity, and degradation in biological systems."
In today’s environment, the pharmaceutical formulator is increasingly challenged to deliver innovative medicines faster in spite of shorter timelines, fewer resources and increasing quality demands. At the same time, ‘evergreening’ existing products by innovator companies has increased due to the patent cliff. Generic companies are also seeking to improve their position and expand indications. Drug delivery is playing a key role in meeting these challenges.
Mike Butler explains how Xceleron is helping its clients to answer critical clinical development questions.