Scaling-Up Exosomes and Other Extracellular Vesicles

The Origin of Biopharmaceutics (Biopharma) derive from The Division of Clinical Research in the U.S. Bureau of Medicine. However, authority is vested in the Division of Biopharmaceutics within the U.S. Food & Drug Administration (FDA), and so if generally considered as official onset of this field of expertise. Shortly after, bedrock concepts and parameters were developed and published. Topics ranging from pharmacokinetics and drug metabolism to bioavailability and bioequivalence were established. It is at this point where protocols and regulatory considerations for Scale-Up of Biologics also began. By extension, this is also the point where many challenges in scaling up/out are rooted.

 

Learning Objectives