#Singapore #HLA-G #Shine-On Biomedical #Esco Aster

Esco Aster's New Venture in Exosome Technology

In a significant advancement for the pharmaceutical industry, Esco Aster, a vertically integrated Cell and Derivatives Contract Research, Development, and Manufacturing Organization (CRDMO) based at the JTC LaunchPad in Singapore, has announced a noteworthy partnership with Shine-On Biomedical. This collaboration centers around a clinical manufacturing contract that focuses on the production of exosomes tailored for a groundbreaking drug delivery platform that targets HLA-G.

The agreement serves as a pivotal step for Shine-On Biomedical, renowned for its innovative approach to drug delivery through exosomes. In 2023, Shine-On Biomedical recognized the capabilities of Esco Aster and enlisted their services to ensure compliance with Good Manufacturing Practices (GMP). This collaboration aims at streamlining the development process for exosomes by leveraging Esco Aster's superior cell line platform.

Development and Regulatory Advancements

As part of this partnership, Esco Aster will contribute to various phases of the exosome development process, including:

• - Technical reports on process development
• - Analysis and formulation of exosomes
• - Loading and stability studies
• - Compliance and technical testing adhering to GMP standards

These initiatives support Shine-On's request for marketing authorization concerning the Shine-On exosome. Notably, in Q1 2025, the U.S. FDA approved the investigational new drug application for Shine-On's product, indicating significant progress toward clinical application.

Hung-Che Chiang, the General Manager of Shine-On Biomedical, stated, "Our preclinical studies have shown promising biodistribution characteristics that warrant further exploration of payloads, including small molecules, nucleic acids, and proteins." This reflects a solid commitment to advancing exosome-based therapies into viable clinical options.

Mitosis™ Solutions and Future Workflows

Parallel to this project, Esco Aster continues to innovate with its Mitosis™ solutions, which aim to enhance GMP workflows specifically for single-use applications in collaboration with China's Medical University Hospital. This foresight showcases Esco Aster's dedication to supporting broader biopharmaceutical initiatives on a regional level.

A Local Pioneer in the Biotechnology Landscape

This collaboration fortifies Esco Aster’s status as Singapore’s premier local CRDMO capable of offering a comprehensive solution for cancer exosome development—truly from cell line creation to GMP manufacturing. Utilizing proprietary technologies such as the 3D Tide Motion™ bioreactor, the company successfully lowers costs while maximizing production efficiency by enabling multiple harvests of conditioned media per cycle.

Moreover, Esco Aster is also actively involved in co-developing autologous cell therapy programs across the ASEAN region, spearheading initiatives like a T-cell reactivation platform targeting KRAS non-G12C mutant non-small cell lung cancer.

Regional Impact and Vision for the Future

Esco Aster’s strategic goals extend beyond mere production capabilities. By promoting biofabrication and facilitating market access and commercialization opportunities in South Asia, ASEAN, and Oceania—a region boasting a GDP of approximately $10.5 trillion and around 2.6 billion inhabitants—Esco Aster is poised to make a significant impact.

Supported by an expansive network of medical centers and clinician-researchers, Esco Aster enhances investigator-initiated trials and early-phase clinical studies, notably in Australia, where research and development incentives foster cost-effective innovation.

In summary, Esco Aster’s collaboration with Shine-On Biomedical marks a notable chapter in the biotechnology field, enhancing capabilities in exosome technology while also demonstrating a commitment to advancing healthcare options across the Asia-Pacific region. The alignment of these two organizations exemplifies the future of precision medicine through biotechnological innovation, encapsulating a vision of "One World BioSolutions for One Health."

For more information, please visit the official websites of Esco Aster and Shine-On Biomedical.