Paid Conditional Approval / Expanded Access

Esco Aster helps orchestrate clinical programs that are post-Phase 1/2a, under paid conditional approval, named-patient trials, expanded access, and compassionate use. We work with our clinical partners, subject to local in-country approvals.

Data collected under GCP/ICH guidelines can then support pivotal Phase II trials, conserving capital for the biotech company. When the work is performed in Australia, it also enables access to the R&D Tax Incentive.

How It Works
  1. Prerequisite: Phase 1/2a completed.
  2. Tech transfer into Esco Aster: Driven by an MSAT-as-a-service approach, we evaluate each customer’s unique User Requirement Specifications (URS) and process—regardless of the technology or application—to identify cost reductions, optimize workflows, or strategically automate and "gmpify" open processes into closed systems (such as using Tide/TideWave where applicable).
  3. Three-way coordination: Esco Aster coordinates with the locally incorporated biotech subsidiary as the sponsor and provides Chain of Custody (COC) and Chain of Identity (COI) services, including starting material preparation, on a fee-for-service basis.
  4. Regulatory filing: Esco Aster Clinical Development supports the sponsor and cancer centre in filing with the local authority.

Delivering Advanced Therapy Development Across Asia-Pacific

Esco Aster is expanding the development and delivery of advanced therapies across the Asia-Pacific region. We support innovators, biotechnology companies, and clinical-stage programs through an integrated platform of bioinnovation, process development, clinical development, and biomanufacturing services.

With Singapore as our Global and Corporate Headquarters, we serve clients and support clinical programs across key APAC and Oceania markets, including Malaysia, Taiwan, Thailand, Cambodia, Greater China, Japan, and South Korea.

Our growing regional footprint reflects the practical application of Esco Aster's capabilities in real-world development programs, from technology and process development to clinical and commercial-stage support.

Eligible Countries

Coming soon: Malaysia and Thailand

Equity Free MetaMorphosis Bioinnovation Venture Accelerator

Esco Aster's role extends beyond contract development and manufacturing. Through MetaMorphosis, we support the creation and acceleration of biotechnology ventures by providing access to technology, infrastructure, technical expertise, development capabilities, strategic capital networks, and commercialization pathways.

MetaMorphosis helps transform promising research and technology into scalable companies while reducing technical and development risks along the journey:

For emerging companies and technology innovators, this is an opportunity to leverage Esco Aster's existing capabilities and infrastructure while progressing toward clinical and commercial milestones.

Through the MetaMorphosis accelerator program, Esco Aster helps biotechs establish a presence in Singapore to obtain grants and strategic capital, with up to SGD 1.2 million in grant funding available through Startup SG Tech.

Grant funding can offset tech transfer costs. Esco Aster can also help you raise strategic capital or find licensees.

Supporting Clients Across the Clinical Development Journey

Esco Aster provides an integrated range of services for companies developing cell and gene therapies, viral vectors, biologics, vaccines, exosomes/extracellular vesicles, and other advanced therapeutic products.

Our capabilities include:

With these capabilities, Esco Aster supports clients as they move from early innovation and technical development toward clinical validation, pivotal development, and commercialization.

Our APAC Footprint

The map represents Esco Aster's current APAC clinical footprint and client/project presence, illustrating the geographic reach of the programs and organizations we support.

From our Singapore headquarters, Esco Aster's activities extend across:

This footprint continues to evolve as Esco Aster works with new partners, clients, and technology innovators across the region.

Our APAC Footprint

Esco Aster's growing APAC presence demonstrates our ability to take advanced therapeutic technologies beyond the laboratory and support their development across multiple markets.

By combining MetaMorphosis venture acceleration, Esco Aster's development and manufacturing services, Tide Motion® technology, and an established regional clinical footprint, we provide clients with a platform designed to support the full development pathway.

Innovation. Development. Clinical Translation. Manufacturing. Commercialization.

Esco Aster is helping build the infrastructure for the next generation of advanced therapies across Asia-Pacific.