Singapore, 12 December 2025 – Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program.  Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025.

Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery.

ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platform for drug development.

Statement From Hung-Che Chiang, General Manager of Shine-On Biomedical
“Preclinical studies have shown promising biodistribution characteristics supporting further exploration across small-molecule, nucleic acid, and protein-based payloads.”

In parallel, Esco Aster, providing Mitosis™ Enterprise Solutions to support potential future evaluation of single-use cGMP workflows at China Medical University Hospital.

This collaboration strengthens Esco Aster’s position as Singapore’s first fully homegrown CRDMO offering end-to-end engineered cancer exosome development—from cell line creation to GMP manufacturing using its patented 3D Tide Motion™ bioreactor. This technology lowers COGS by enabling multiple conditioned media harvests per run. Esco Aster also co-develops autologous cell therapy programs in ASEAN, including a T-cell reactivation platform targeting non-G12C KRAS mutation NSCLC.

Esco Aster supports Asia-Pacific innovators through biomanufacturing scale-up, market access, and commercialization across South Asia, ASEAN, and Oceania—a region valued at ~USD 10.5 trillion GDP with ~2.6 billion people. Supported by a network of medical centres and clinician-scientists, Esco Aster facilitates IIT and FIM studies, especially in Australia, where R&D incentives lower costs. The company advances its “One World BioSolutions for One Health” vision, enabling high yield at low GMP cost to strengthen Singapore’s and Asia’s bioeconomy. 

For additional press coverage of this announcement, please visit:
BioInformant – Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract with Shine On Biomedical
https://bioinformant.com/esco-aster-signs-exosome-clinical-cgmp-manufacturing-contract/ 

About Esco Aster
Esco Aster is a global contract research, development, and manufacturing organization (CRDMO) dedicated to enabling the seamless translation of biopharmaceutical innovations from laboratory concept to clinical application. Leveraging proprietary continuous and adherent bioprocessing platforms, Esco Aster provides end-to-end solutions spanning process development, cGMP manufacturing, analytics, and regulatory support for cell therapies, gene therapies, vaccines, biologics, and exosome-based therapeutics. With a strong commitment to quality, scalability, and affordability, Esco Aster empowers biotech and pharmaceutical partners worldwide to accelerate development timelines and achieve reliable clinical and commercial outcomes. Learn more at www.escoaster.com.

About Shine-On Biomedical Co., Ltd.
Shine-On Biomedical Co., Ltd. is a Taiwan-based biotechnology company pioneering the development of targeted exosome therapeutics and next-generation multispecific biologics. Established in 2021, Shine-On combines advanced engineering platforms—including HLA-G targeted exosome delivery systems and trispecific T-cell engager technologies—to create precision medicines for cancer and other diseases with high unmet clinical needs. The company is recognized among Taiwan’s leading innovators in exosome drug development and is actively advancing a pipeline of novel therapeutic candidates toward clinical evaluation. Learn more at https://en.shineon-bio.com.