#Singapore #exosome therapy #Shine-On Biomedical #Esco Aster

Esco Aster and Shine-On Biomedical Collaboration on a Game-Changing Exosome Drug Delivery Platform

In a groundbreaking partnership, Esco Aster, a leader in cell and derivative contract research and development, has joined forces with Shine-On Biomedical to advance a novel exosome drug delivery platform focused on HLA-G targeting. Based at the JTC LaunchPad in Singapore, Esco Aster will provide comprehensive cGMP manufacturing support, setting the stage for innovative cancer therapies.

The Role of Esco Aster

Esco Aster's commitment to excellence in biomanufacturing shines through its vertical integration in the clinical research, development, and manufacturing organization (CRDMO) space. Their state-of-the-art facility is designed to facilitate high-yield exosome processing, which is essential for drug development. For this collaborative project, Esco Aster is leveraging its proprietary cell line platform to enhance the efficiency and efficacy of exosome production.

Earlier in 2023, Shine-On Biomedical enlisted Esco Aster to undertake various cGMP services, beginning with the high-yield development of exosomes. This included extensive technical support across process development, analytical assessments, and formulation strategies essential for exosome drug loading. The development process culminated in successful GMP engineering runs that significantly aid in the upcoming submission to the U.S. FDA.

FDA Clearance and Future Outlook

Notably, the Investigational New Drug (IND) application submitted by Shine-On Biomedical received clearance from the U.S. FDA in the first quarter of 2025. This marks a significant milestone for the partnership, paving the way for Shine-On's proprietary product, SOB100, to enter into human clinical trials.

Hung-Che Chiang, General Manager of Shine-On Biomedical, expressed optimism regarding preclinical studies, highlighting that they demonstrated promising biodistribution characteristics. These findings strengthen the rationale for exploring not just small-molecule therapeutics, but also nucleic acid and protein-based drug candidates.

Technological Advancements for Future Studies

To support ongoing research, Esco Aster is also conducting exploratory studies on exosome loading as per Shine-On's specific instructions. These studies will provide critical insights that may be utilized in larger scale clinical applications, enabling a broader range of therapeutic options.

Moreover, Esco Aster has introduced Mitosis™ Enterprise Solutions—an innovative approach to assess single-use cGMP workflows specifically for China Medical University Hospital. This move reflects Esco Aster's dedication to research advancement and optimization in biomanufacturing practices.

Strengthening the Bioeconomy

Through this collaboration, Esco Aster is not only positioning itself as Singapore's premier homegrown CRDMO but also enhancing its reach across the Asia-Pacific region. The company’s capabilities in engineered cancer exosome development, from initial cell line creation to GMP manufacturing, empower biomedical innovators in a region with a significant economic footprint.

With an estimated GDP of around USD 10.5 trillion and a population exceeding 2.6 billion, the Asia-Pacific market presents a golden opportunity for advancing healthcare technologies. Esco Aster's efficiency in biomanufacturing facilitates better market access and commercialization pathways for products emerging from this collaborative venture.

Conclusion

This significant partnership signifies a promising avenue for drug delivery innovations using exosome technology. Esco Aster and Shine-On Biomedical aim to redefine therapeutic interventions contributing to advanced patient care solutions. By aligning their vision of "One World BioSolutions for One Health," they are set to enhance not only the local bioeconomy of Singapore but also the broader landscape of global healthcare.