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Perspectives on Continuous Processing

By: Howard Levine
Presented at BioProcess International Conference and Exhibition, Sep 25-28; Boston, MA. 
This presentation is a perspective on the evolution from batch to continuous processing underway in the the biopharmaceutical industry. Batch processing has long been the norm for the pharmaceutical industry. In part, it has persisted due to an “If it ain’t broke, don’t fix it” mentality on the part of industry and regulators. However, as the biopharmaceutical industry looks to the future and seeks to be more adaptive to patient needs in delivering life-saving medicines quickly, efficiently, and cost effectively, a new paradigm in biomanufacturing is taking hold. Continuous processing has become the norm in almost every other major industry segment addressing issues of scale, flexibility, and cost while improving overall product quality. Our factories of the future, especially those producing products for rare diseases and niche markets, need not be massive. Instead, flexible, modular facilities embracing single-use technologies and continuous processing will enable companies to meet the needs of more localized populations. As in other industries, continuous processing will allow the biopharmaceutical industry triumph over the challenges of cost, scale, and flexibility to the benefit of patients worldwide. As our industry slowly adopts the principles of continuous manufacturing, we have moved from asking the question of “How do we do it?” to the realm of implementation, stating “Look what we’ve done!”