We are witnessing the rapid advancement of complex new modalities, such as cell and gene therapies, novel vaccines, engineered extracellular vesicles and virus-like particles, jointly referred to as ATMPs.  While ATMPs offer an unparalleled therapeutic potential, their immense complexity (when compared to traditional biotherapeutics, e.g., recombinant proteins and antibody) poses significant challenges to large scale GMP manufacturing.  This presentation will review the applicability of certain bioprocessing concepts developed for traditional modalities to the manufacture of ATMPs.  Exosome biotherapeutics will be used as an example, where the  application of such concepts, evolved into a new form, has been tremendously successful. <br/>Exosomes are rapidly evolving as a promising new modality in various clinical areas, such as oncology, immuno-oncology, neurology and metabolic diseases, among others.  As some of these indications involve large patient populations, the success of exosome therapeutics depends on our ability to manufacture allogenic exosomes at a large scale, with high purity and quality, acceptable CoG, and under GMP conditions.  To this end, we have developed an advanced manufacturing platform including a 500L high-density perfusion bioreactor growing engineered human cells, and an optimized sequence of filtration and chromatography steps yielding exosomes of high purity and quality.  Opportunities for a further multifold increase of process productivity through cell line engineering, media development, and implementation of integrated continuous methodology will be also outlined.

Advanced manufacturing of ATMPs:  Industrialization of exosome production using intensified continuous technology

ACS Spring 2022

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