Regulatory Perspective on Extended Characterization, Setting the Specifications & CQA to Evolve Your ADC From Discovery Through Clinical Development & Regulatory Filing
Physiochemical Assays Outside of DAR Distribution/Characterization to Produce a More Holistic Analytical Profile of Your ADC
Enhancing Quantification of Free Drug to Set the Limits in the Free Drug Assays & Demonstrate Lack of Toxicity
Turbocharging Bioassay Development to Overcome Long Development Times & Ensure You Can Update Development Conditions at an Earlier Stage
Purity Assays to Better Analyse Impurities & Justify Their Presence in the Final Drug Product
Shattering the Mystery Behind DAR Distribution & Characterization to Platform the Process & Have Better Control Over It
Overcoming Variability With Potency Assays to Reduce Complexity & Show Its Working in Representing the Actual Potency of the ADC
Venue
Hilton Boston Back Bay ,
40 Dalton Street, Boston, Massachusetts, United States
