Biologics Characterization and Manufacturing
Win the race to FDA approval with iCE and MFI
The success of the drug development process is directly proportional to the utilization of accurate, sensitive and fast analytical methods for identification, quantitation, purity and other analyses of the drug substance and the drug product that you don’t get with many technologies.
iCE™ and MFI™ from ProteinSimple streamline measurement and quantification of the complex interactions between a drug product and the manufacturing process. Whether it’s the infrastructure, the vial or syringe, the cap, or the excipients and stabilizers that are in solution, it is important to understand how these affect the stability and activity of the product in order to prevent enhanced immunogenicity, loss of biologic activity, as well as hyperactivity. All of which constitute a risk for the patients and the company as a whole.
This e-book will take you on the journey through product development and provide specific examples of how iCE and MFI have been used in the race to FDA approval.