Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing

Wednesday, January 8, 2014 at 10:00 AM - 11:00 AM Eastern Standard Time (EST) and
Wednesday, January 15, 2014 at 10:00 AM - 11:00 AM Central European Time (CET)

High-potency manufacturing requires specialized facility capabilities, equipment selection, and manufacturing processes to achieve the desired levels of containment that meet occupational safety requirements. Selecting a contract manufacturing organization to handle your highly potent compound can be a time-consuming and difficult task. Often, much of the difficulty comes from not anticipating the information needs that a CMO requires prior to bringing your highly potent compound into its facility. In addition, identifying the key technical and production capabilities required of a CMO partner is crucial for effective CMO selection and project execution. This 60-minute webcast will examine:
  • The definition/classification of potent compounds
  • The types of toxicology information needed for preclinical and clinical development and commercial production
  • The systems, processes, procedures and capabilities required for handling and manufacturing high-potency pharmaceuticals
  • Strategies for effective project management and execution.

Key Learning Objectives
  • Understand the capabilities for containment, monitoring, waste disposal, analytical, process safety, material handling, and packaging required for high-potency manufacturing
  • Understand the industrial hygiene information, requirements, and operator training and skills needed for the safe handling of potent compounds
  • Gain insight for effective CMO selection, qualification, and collaboration for product launch.


Rita Peters

Editorial Director
Pharmaceutical Technology


Dean Calhoun

President and CEO
Affygility Solutions

Kenny McCleary
Senior International ESH Advisor
Evonik Corporation

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