(206f) Continuous Crystallization Process Development

Batch-based manufacturing system currently employed by the pharmaceutical industry is costly and inefficient. A drug’s active ingredients are synthesized in a chemical manufacturing plant and then shipped to a separate facility where they are converted into large batches of pills, liquids, or creams. With multiple interruptions, including transport to separate locations, the production of just one batch of drugs can take weeks. What’s more, the manufacturing design and scale-up required to produce a new drug can be financially unsustainable and exceedingly time-consuming. Continuous Processes/Manufacturing offers a paradigm shift that will enable the industry to produce quality products more efficiently. Continuous crystallization has long been a standard method for the crystallization of bulk commodity chemicals and large-volume specialty chemicals, but it has only recently become a focus in the pharmaceutical and fine chemical industries. This presentation will:

• Highlight the current approaches to continuous crystallization

• Assess the advantages of a continuous crystallization process

• Analyze the key challenges and draw on real life case studies to present the key points