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.

总部位于新加坡JTC LaunchPad的垂直整合细胞和衍生物CRDMO公司Esco Aster宣布，将为Shine-On Biomedical的HLA-G靶向外泌体项目提供CMC制造支持。Shine-On Biomedical在2023年赞助了Esco Aster的cGMP服务，首先利用Esco Aster的细胞系平台进行高产外泌体开发。

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..

工艺、分析和配方开发、外泌体载药、GMP工程运行和稳定性研究的技术报告支持了Shine-On的IND申请。该IND于2025年第一季度获得美国FDA的批准。

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.

此外，根据Shine-On的指示，Esco Aster正在为探索性外泌体载药可行性研究提供技术服务。Shine-On生物医学是一家新兴的外泌体药物递送创新者。

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.

ShineOn的专利产品SOB100，一种靶向HLA-G的外泌体药物递送载体，已通过美国FDA的IND审查，并正在进行I期临床研究，成为潜在的首个靶向HLA-G的外泌体药物开发平台。

Statement From Hung-Che Chiang, General Manager of Shine-On Biomedical

江宏哲声明，尚昂生物医学总经理

“Preclinical studies have shown promising biodistribution characteristics supporting further exploration across small-molecule, nucleic acid, and protein-based payloads.”

“临床前研究显示了支持小分子、核酸和蛋白质类载体进一步探索的有希望的生物分布特性。”

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

同时，Esco Aster 提供 Mitosis™ 企业解决方案，以支持中国医科大学医院未来对一次性 cGMP 工作流程的潜在评估。

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.

此次合作加强了Esco Aster作为新加坡首家完全本土化的CRDMO的地位，提供从细胞系创建到使用其专利的3D Tide Motion™生物反应器进行GMP生产的端到端工程化癌症外泌体开发。该技术通过实现每次运行多次收集条件培养基，降低了商品销售成本（COGS）。

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还在东盟共同开发自体细胞治疗项目，包括针对非G12C KRAS突变的非小细胞肺癌的T细胞再激活平台。

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.

Esco Aster 通过生物制造规模扩大、市场准入和商业化支持亚太地区的创新者，覆盖南亚、东盟和大洋洲——这一地区GDP约为10.5万亿美元，人口约26亿。依托医疗中心和临床科学家网络，Esco Aster 推动IIT和FIM研究，特别是在澳大利亚，研发激励政策降低了成本。

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. .

公司推进“One World BioSolutions for One Health”愿景，以低成本的GMP实现高产量，助力新加坡和亚洲的生物经济发展。

For additional press coverage of this announcement, please visit:

有关此公告的更多媒体报道，请访问：

BioInformant – Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract with Shine On Biomedical

BioInformant——Esco Aster与Shine On Biomedical签署外泌体临床cGMP制造合同

https://bioinformant.com/esco-aster-signs-exosome-clinical-cgmp-manufacturing-contract/

https://bioinformant.com/esco-aster-签署外泌体临床cGMP制造合同/

About Esco Aster

关于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.

Esco Aster 是一家全球性的合同研究、开发和制造组织 (CRDMO)，致力于实现生物制药创新从实验室概念到临床应用的无缝转化。通过利用其专有的连续性和贴壁式生物处理平台，Esco Aster 提供涵盖工艺开发、cGMP 生产、分析和监管支持的端到端解决方案，适用于细胞疗法、基因疗法、疫苗、生物制品以及基于外泌体的治疗药物。

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..

Esco Aster 致力于质量、可扩展性和经济实惠性，为全球生物技术和制药合作伙伴提供支持，助力加速开发进程，并实现可靠的临床和商业成果。欲了解更多信息，请访问 www.escoaster.com。

About Shine-On Biomedical Co., Ltd.

关于上海闪亮生物医药科技有限公司

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.

光曜生物医药有限公司是一家总部位于台湾的生物技术公司，率先开发靶向外泌体疗法和下一代多特异性生物制品。光曜成立于2021年，结合了先进的工程平台，包括HLA-G靶向性外泌体递送系统和三特异性T细胞接合器技术，为癌症和其他具有高度未满足临床需求的疾病创造精准药物。

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..

该公司被公认为台湾外泌体药物开发的领先创新者之一，正在积极推进一系列新型治疗候选药物进入临床评估阶段。欲了解更多信息，请访问 https://en.shineon-bio.com。

Source: escoaster.com

来源：escoaster.com