Large scale production and characterization of exosomes

Exosome-based therapeutics are rapidly evolving as a new modality with a promising potential in multiple clinical areas. Successful implementation requires development of robust large-scale processes for the manufacture of highly purified material. However, the complexity and heterogeneity of exosomes pose significant R&D challenges. Here, we present the successful development of a manufacturing process using immortalized human cells, currently operating at commercial scale. Contrary to traditional ultracentrifugation approaches for exosome production, our process is based on modern biochemical engineering principles, resulting in a robust and scalable operation. The related analytics and characterization methods are also discussed

Complex new modalities require advanced bio manufacturing platforms: The case of exosome biotherapeutics

Exosome-based therapeutics are rapidly evolving as a high potential new modality in multiple clinical areas such as oncology, immuno oncology, neurology and tissue regeneration, among others. As these indications involve large patient populations, the implementation of exosome therapeutics requires robust manufacturing processes yielding large quantities of highly purified material. However, the complexity and heterogeneity of exosomes pose significant R&D challenges. Here, we present the successful development of a large-scale manufacturing process using engineered human cells grown in a high-density continuous culture. The upstream process is followed by a sequence of purification steps yielding material of high purity and quality. The related analytical and characterization methods are also discussed

Exosome-based Biotherapeutics: Opportunities, development and path to commercialization

Over the last quarter century, we have witnessed the emergence of a diverse portfolio of biotech drug modalities, ranging from recombinant proteins to cell and tissue therapies. In general, there is a trend toward growing drug complexity, following the deeper understanding of disease biology. While the biochemical engineering concepts employed in the manufacturing of these modalities reflect this diversity, significant benefits have been gained through development of bioprocessing platforms with broader applicability. This presentation will focus on the potential of exosome-based therapeutics, a new modality that has witnessed tremendous progress over the last few years. The bioprocess and analytical technologies for their future commercialization will be discussed in the context of the capabilities and limitations of the existing biomanufacturing platforms

Industrialization of the GMP manufacture of exosome therapeutics and opportunities for further multifold process productivity increase

Exosome therapeutics 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. Due to the complexity and natural heterogeneity of exosomes, the development of such an advanced production technology is not a trivial task. This presentation will discuss our ability to develop GMP processes to manufacture precisely engineered engEx exosomes from Codiak’s pipeline. With two lead programs in clinical trials in cancer patients, and an IND approved for a third program in immuno-oncology this year, we have significantly scaled our GMP production capacity. Our large-scale process uses either 2,000L fed-batch or, more recently, 500L high-density perfusion bioreactors culturing HEK cells at high density in chemically defined media. The bioreactor harvest is processed through a sequence of purification steps yielding exosomes of high potency and purity, and with consistent quality attributes. Opportunities for a further multifold increase of process productivity and reduction of CoG through implementation of integrated continuous biomanufacturing technology will be outlined. This presentation will also review the applicability of the above technology to the manufacture of other ATMPs

The multidimensional evolution of ICB: New concepts, technology, and therapeutic modalities

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Si-based anode materials for lithium rechargeable batteries

Silicon is a very promising candidate to replace graphite as the anode in Li-ion batteries because of its very high theoretical capacity, relatively low cost and low toxicity. However, it has not yet made its way into commercial cells. This review highlights recent progress on Si-based anode materials for lithium rechargeable batteries